CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/06/088464 [Registered on: 10/06/2025] Trial Registered Prospectively

Last Modified On:

17/08/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (SOS-AMI)

Scientific Title of Study

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (SOS AMI) Multi center, double blind, randomized, placebo controlled, parallel group study to evaluate the efficacy and safety of self administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction

Trial Acronym

Not applicable

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
2023-505438-85-00	EudraCT
NCT04957719	ClinicalTrials.gov
Protocol No.: ID-076A301 version: 7.0 dated 09 May 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr JPS Sawhney
Designation	Chairman
Affiliation	Sir Ganga Ram Hospital
Address	Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Room # F25, First floor, Casualty building, Rajinder Nagar, New Delhi, Delhi - 110060 New Delhi DELHI 110060 India New Delhi DELHI 110060 India
Phone	01135125600
Fax
Email	jpssawhney@yahoo.com

Details of Contact Person
Scientific Query

Name	Dr Sanjeev Hegde
Designation	Head of Clinical Operations
Affiliation	Mylan Pharmaceutical Pvt Ltd
Address	Mylan (Viatris), Prestige Platina 3, 7-11 floor, Prestige Tech Park II, Varthur Hobli, Outer Ring Road, Kadubesanahalli, Bengaluru-560103 India Bangalore KARNATAKA 560103 India
Phone	08066728587
Fax
Email	sanjeev.hegde@viatris.com

Details of Contact Person
Public Query

Name	Dr Sanjeev Hegde
Designation	Head of Clinical Operations
Affiliation	Mylan Pharmaceutical Pvt Ltd
Address	Mylan (Viatris), Prestige Platina 3, 7-11 floor, Prestige Tech Park II, Varthur Hobli, Outer Ring Road, Kadubesanahalli, Bengaluru-560103 India Bangalore KARNATAKA 560103 India
Phone	08066728587
Fax
Email	sanjeev.hegde@viatris.com

Source of Monetary or Material Support

Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91 CH-4123 Allschwil Switzerland

Primary Sponsor
Modification(s)

Name	Viatris Innovation GmBH
Address	Gewerbestrasse 14 CH-4123 Allschwil Switzerland
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
MYLAN PHARMACEUTICALS PRIVATE LIMITED	Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad- 500 096, Telangana, India

Countries of Recruitment

Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Denmark
Estonia
Finland
France
Georgia
Germany
Greece
Hungary
India
Israel
Italy
Japan
Lithuania
Mexico
Netherlands
New Zealand
Norway
Peru
Poland
Portugal
Republic of Korea
Romania
Saudi Arabia
Serbia
Slovakia
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Arab Emirates
United Kingdom
United States of America

Sites of Study
Modification(s)

No of Sites = 87
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ajay Chaurasia	Municipal Corporation of Greater Mumbai Topiwala National Medical College and BYL Nair Ch Hospital	Department of Cardiology, Municipal Corporation of Greater Mumbai Topiwala National Medical College and BYL Nair Ch Hospital, AL Nair road, Mumbai central, Mumbai-8 Mumbai MAHARASHTRA	9821317392 drajaychaurasia@hotmail.com
Dr Atul Kaushik	All India Institute of Medical Sciences	Department of Cardiology, All India Institute of Medical Sciences, Marudhar Industrial area, Basni Phase II, Jodhpur, Rajasthan, India- 342005 Jodhpur RAJASTHAN	9818358059 Kaushika@aiimsjodhpur.edu.in
Dr Debasis Acharya	All India Institute of Medical Sciences	All India Institute of Medical Sciences, AIIMS Road, Sijua, Patrapada, Bhubaneswar, Odisha- 751019 Khordha ORISSA	9862453219 cardio_debasish@aiimsbhubaneswar.edu.in
Dr Rakesh Yadav	All India Institute of Medical Sciences, New Delhi	South Delhi, 110029, Delhi, India South DELHI	9868026888 rakeshyadav123@yahoo.com
Dr Bhupinder Singh	All India Intitute of Medical Sciences	Department of Cardiology, All India Intitute of Medical Sciences, Mandi Dabwali road, Jodhpur Romana, Bathinda, Punjab-151001, India Bathinda PUNJAB	8427821837 doc_bhupi@rediffmail.com
Dr Navin Mathew	Amrita Institute of Medical Sciences and Research Centre	Dept.of Cardiology, AIMS-Ponekkara.P.O, Kochi-682041, Kerala, India Ernakulam KERALA	9495480544 navinmathew@aims.amrita.edu
Dr Brij Mohan Goyal	Apex Hospitals Pvt Ltd	SP-4 & 6, Central Road, Malviya Nagar Industrial Area, Malviya Nagar, Jaipur, Rajasthan 302017 Jaipur RAJASTHAN	9413141104 drbrijmohan96@gmail.com
Dr Jaspal Arneja	Arneja Heart & Multispeciality Hospital	123, Ramdaspeth, Nagpur, Maharashtra, India- 440010 Nagpur MAHARASHTRA	9823066007 Drjaspal@arnejaheartinstitute.com
Dr Shrikant Despande	Ashirwad Hospital & Research Centre	Maratha Section, Near Jijamata Udyan, Ulhasnagar -421004, Maharashtra, India Thane MAHARASHTRA	9822017445 Writetoshrikant1957@gmail.com
Dr Rajeev Marwaha	Atal Institute of Medical Super Specialities	Department of Cardiology, 1st floor, Room number-119, Atal Institute of Medical Super Specialities, Shimla- 171006 Shimla HIMACHAL PRADESH	177-2800168 rajeev.marwaha@gmail.com
Dr Upendra Kaul	Batra Hospital and Medical Research Centre	Batra Hospital and Medical Research Centre, Ground floor, Gate#3, Department of Academic and Research, 1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110062 DELHI New Delhi DELHI	9811150518 upendra.kaul@batrahospitaldelhi.org
Dr Vaibhav Bansidhar Patil	Bharati Vidyapeeth Medical College Hospital and Research Center	Bharati Vidyapeeth Medical College Hospital & Research Centre, Pune-Satara Road, Dhankawadi, Pune 411043, Maharashtra, India Pune MAHARASHTRA	8151096369 patilvaibhav27@ymail.com
Dr Girish Sonwalkar	BHS lakeview hospital	R.S No. 73/7, C.T.S No. 11888, Gokak Road, 73/7, opp. Fort Lake, Azad Nagar, Gandhi Nagar, Belagavi- 590016 Karnataka, India Belgaum KARNATAKA	9448144615 drGirishSonwalkar@gmail.com
Dr Sunil Washimkar	Central India Cardiology Hospital & Research Institute	Plot No. 1, Pioneer Co-Op Housing Society, Gawande Layout, Khamla Ring Road, Opp. Sawarkar Garden, Khamla, Nagpur-440015, Maharashtra, India. Nagpur MAHARASHTRA	9823065380 sunil_wash@rediffmail.com
Dr Manish Kumar Jha	Charak Hospital and Research Centre	Department of Cardiology, Charak Hospital and Research Centre, Hardoi road, Dubagga, Lucknow, Uttar Pradesh- 226003, India Lucknow UTTAR PRADESH	7054842318 rkslko.09@gmail.com
Dr Manojkumar Chopda	Chopda Medicare & Research Centre Pvt Ltd	3/5 Patil Lane No.1, Laxmi Nagar, Near K. B. H. Vidyalaya, Canada Corner, Nashik- 422005 Maharashtra, India Nashik MAHARASHTRA	9823021613 drchopdamanoj@gmail.com
Dr Hasmukh Gujar	CMETs Inamdar Hospital,	Vitthal Rao Shivarkar Road, Fatima Nagar, Wanowrie, Pune, Maharashtra 411013 Pune MAHARASHTRA	9226737554 drhasmukhgujar@gmail.com
Dr Mohd Aziz Khan	Crescent Hospital and Heart Centre	Near Lokmat Square, Dhantoli, Nagpur-440012 Maharashtra, India Nagpur MAHARASHTRA	9823056551 khandraziz@yahoo.com
Dr Naveen Jamwal	Dr. Ram Manohar Lohia Institute of Medical Sciences	Department of Cardiology, Vibhuti Khand, Gomti Naga, Lucknow- 226010 Lucknow UTTAR PRADESH	9415112357 drdrjamwwal@yahoo.com
Dr Tummala Sadanand Reddy	Employees’ State Insurance Corporation Super Speciality Hospital	7-1-634, Survey# 121/1 and 121/2, National Highway 65, Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad- 500038 Hyderabad TELANGANA	8142345693 tummalasreddy@gmail.com
Dr Joyal Shah	EPIC Hospital (A unit of Vatsalya Healthcare LLP)	Rajpath Rangoli road, Opposite Pandit Dindayal Auditorium hall, Behind Rajpath club, Bodakdev, Ahmedabad- 380054, Gujarat, India Ahmadabad GUJARAT	9825319645 drjoyal@gmail.com
Dr Atul Mathur	Fortis Escorts Heart Institute	Okhla road, New Delhi- 110025 New Delhi DELHI	9810187115 atul.mathur@fortishealthcare.com
Dr Arun Kochar	Fortis Hospital	Phase 8, Sector 62, Mohali, Punjab-160062 Chandigarh CHANDIGARH	9815266033 arun.kochar@fortishealthcare.com
Dr Vishal Batra	GB Pant Institute of Post Graduate Medical Education & Research	Department of Cardiology, 1, JLN Marg, 64 Khamba Road, Rajghat, New Delhi-110002 New Delhi DELHI	9758363967 drvishalbatra84@gmail.com
Dr Roopesh Singhal	GCS Medical College, Hospital and Research Centre	Opposite DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad – 380025, Gujarat, India. Ahmadabad GUJARAT	9099016535 roopeshrsinghal@gmail.com
Dr Parigela Prasanth	Government General Hospital	Department of Cardiology, First floor, Super Speciality Block,, Budhawara Peta, Kurnool-518002, Andhra Pradesh, India Kurnool ANDHRA PRADESH	8639163817 parigalanani@gmail.com
Dr Sajeer Kalathingathodika	Government Medical College	Department of Cardiology, Government Medical College, Kozhikode, Kerala- 673008 Kozhikode KERALA	9539912575 drsajeerkt@gmail.com
Dr K Venkateswara Rao	Government Medical College & Hospital	Bhagya Nagar, Ongole, Prakasam, Andhra Pradesh-523001 Prakasam ANDHRA PRADESH	9704855667 kvrao5113@gmail.com
Dr Ravi Vishnu Prasad	Indira Gandhi Institute of Medical Sciences	Sheikhpura, Patna, 800014, Bihar, India Patna BIHAR	9431646727 drravivishnuprasad@gmail.com
Dr Gouranga Sarkar	IPGME& R and SSKM Hospital	244, Acharya Jagadish Chandra Bose Road, Kolkata-700020, West Bengal, India Kolkata WEST BENGAL	8910236595 drgsmed@gmail.com
Dr Santosh Satheesh	Jawaharlal Institute Of Post Graduate Medical Education Medical Education and Research (JIPMER)	Department of cardiology, Ground floor, Super Speciality block, JIPMER, Puducherry Pondicherry PONDICHERRY	8220791555 drsanthoshsatheesh@gmail.com
Dr Santhosh Satheesh	Jawaharlal lnstitute of Post.Graduate Medical Education and Research	Department of Cardiology, Ground floor, Super Specialty block, JIPMER, Puducherry-605006 Pondicherry PONDICHERRY	8220791555 drsanthoshsatheesh@gmail.com
Dr Malik Mohd Azharuddin	Jawaharlal Nehru Medical College and Hospital	Aligarh Muslim University, Civil Line, Aligarh - 202002, Uttar Pradesh, India Aligarh UTTAR PRADESH	8126320218 malikazharuddin@gmail.com
Dr Pruthviraj Puwar	Jupiter Hospital	Sun-Pharma Atladra Rd, opposite ICAI Bhavan, Pramukh Swami nagar, Atladara, Vadodara-390012, Gujarat, India Vadodara GUJARAT	8866444474 drprithvirajnm@gmail.com
Dr Sujal Kumar Shetty	Justice K S Hegde Charitable Hospital	Deralakate, Mangalore University Road, Mangalore, 575018, Karnataka, India Dakshina Kannada KARNATAKA	8197879288 cardioctksh@gmail.com
Dr Ajit Bhagwat	Kamalnayan Bajaj Hospital	Gut no. ,43, Satara Parisar, Beed bypass Road, Sambhajinagar-431010, Maharashtra, India. Aurangabad MAHARASHTRA	9822050817 drbhagwat.knb@gmail.com
Dr Tom Devasia	Kasturba Medical College and Hospital	MAHE Manipal-576104, Karnataka, India Udupi KARNATAKA	9448158508 tom.devasia@manipal.edu
Dr Milind Gadkari	KEM Hospital	Department of Cardiology, 5th floor, Diamond Jubilee building, Rasta peth, Pune-411011, Maharashtra, India Pune MAHARASHTRA	9822030120 gadkarisa@gmail.com
Dr Nitthiyan Palaniswami	KG Hospital And Post Graduate Medical Institute & Research Centre	No- 5, KG Hospital and Post Graduate Medical Institute & Research Centre, Government Arts College Road, Coimbatore-641018, Tamil Nadu India Coimbatore TAMIL NADU	9159940950 nitthi94@yahoo.com
Dr Santosh Kumar Teppa	King George Hospital	Department of Cardiology, King George Hospital, Andhra Medical college, Maharanipeta, Visakhapatnam, 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH	9642636369 drtsantoshkumaresearch@gmail.com
Dr Rishi Sethi	King George Medical University	Department of Cardiology, Gate no.12, New block, Second floor, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh, 226003 Lucknow UTTAR PRADESH	9415085717 drrishisethi1@gmail.com
Dr Alok Ranjan	Kiran Multi Super Speciality Hospital and Research Centre	Near Sumul Dairy, Surat, Gujarat- 395004, India Surat GUJARAT	9099927100 dralokbranjan@gmail.com
Dr M R Prasad	KLES Dr. Prabhakor Kore Hospital and Medical Research centre	Nehru Nagar, Belagavi - 590010, Karnataka, India. Belgaum KARNATAKA	9243245777 drprasadmr@gmail.com
Dr Rajendra Kumar Jain	Krishna Institute of Medical Sciences Limited	1-8-31/1, Minister Road, Secunderabad-500003, Telangana, India Hyderabad TELANGANA	9848029443 kumarpre@hotmail.com
Dr Anandkumar Valsakumar	Lakeshore Hospital and Research Centre Ltd.	Ernakulam Maradu, Nettoor P.O., Kochi -682040, Kerala, India Ernakulam KERALA	9249488064 anandheart@gmail.com
Dr Polavarapu Veeraraghava Sarma	Lalitha Super Specialities Hospital Pvt Ltd,	Kothapet Main Rd, Kothapeta, Guntur, Andhra Pradesh 522001 Guntur ANDHRA PRADESH	9440808620 Drpvr.lssh@gmail.com
Dr Jabir Abdullakutty	Lisie Hospital	Lisie Hospital Rd, North Kaloor, Kaloor, Ernakulam, Kerala 682018 Ernakulam KERALA	9447011773 drjabi@yahoo.co.in
Dr Prashant Udigre	Mahatma Gandhi Missions’s Medical College & Hospital	Department of Pharmacology & Clinical Trial Center,N-6 CIDCO, Chatrapati Sambhaji Nagar - 431003, Maharashtra, India Aurangabad MAHARASHTRA	9503181111 udgire@rediffmail.com
Dr Ajmera Prakash	Malla Reddy Narayana Multispeciality Hospital,	Suraram X roads, Jeedimetla, Quthbullapur, Hyderabad- 500055 Hyderabad TELANGANA	9985401317 wglprakash@yahoo.com
Dr C B Keshavamurthy	Manipal Hospital Mysore	No. 85-86, Mysore-Bangalore ring road junction, Bannimantapa A layout, Siddiqui Nagar, Mysore-570015 Mysore KARNATAKA	8310100013 cbkeshavamurthy@gmail.com
Dr Satya Gupta	Marengo CIMS Hospital	Marengo CIMS Hospital 2nd floor, West building Opposite Panchamrut Bunglows Near Shukan Mall Off Science City Road Sola Ahmedabad Gujarat 380060 Ahmadabad GUJARAT	9925045780 satya.gupta@cims.me
Dr Viveka Kumar	Max Super Speciality Hospital Saket	2, Press Enclave road, Saket, New Delhi- 110017 New Delhi DELHI	9871001190 viveka.kumar@maxhealthcare.com
Dr Gaurav Minocha	Max Super Speciality Hospital Vaishali	Max Super Speciality Hospital Vaishali, W-3, Sector 1, Ghaziabad, 201001, Uttar Pradesh, India Ghaziabad UTTAR PRADESH	9910922299 gminocha27@yahoo.co.in
Dr Sanjay Mittal	Medanta - The Medicity	CH Bakhtawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001 Gurgaon HARYANA	9910044477 sanjay.mittal@medanta.org
Dr Sridhar Papani	Medicover Hospitals	Opposite Cyber Gateway, IBIS Hotel, Hitec City, Hyderabad-500081, Telangana, India Hyderabad TELANGANA	9490572735 Seedhi123@gmail.com
Dr Sivakumar Rathnavel	Meenakshi Super Speciality Hospital	171, Lake Area, Melur Road, Uthangudi, Madurai-625107,TamilNadu, India Madurai TAMIL NADU	9842158870 drsivakumar2004@gmail.com
Dr Abhishek Sachdeva	Moti Lal Nehru Medical College and Associate Swaroop Rani Nehru Hospital	George town, Civil line, Prayagraj, Uttar Pradesh- 211001, India Pratapgarh UTTAR PRADESH	99908 50478 drabhisheksachdeva@gmail.com
Dr Srikanth KV	Narayana Health - Institute of Cardiac Sciences	258/A, Bommasandra Indl Area, Hosur Road, Anekal Taluk, Bangalore- 560099 Bangalore KARNATAKA	9342659468 srikanth.kv.dr01@narayanahealth.org
Dr Vinod Sharma	National Heart Institute	49-50 Community Center, East of Kailash, New Delhi, Delhi-110065 New Delhi DELHI	9810131739 drvs.nhi@gmail.com
Dr Atul Abhyankar	Nirmal Hospital Pvt Ltd	Nirmal Hospital Pvt Ltd, Ring road, Surat, Gujarat, 395002 Surat GUJARAT	9825145738 heartfirst.surat@gmail.com
Dr Hitendra Bhagwatkar	NKP salve Institute of Medical Science & Research Centre and Lata Mangeshkar Hospital	Digdoh Hills, Hingna Road Nagpur- 440019 Maharashtra, India Nagpur MAHARASHTRA	9096115922 Hitendrabhagwatkar@gmail.com
Dr Krishna Mala Konda Reddy P	Osmania General Hospital	Department of Cardiology, QQDC Building, 1st floor, Osmania General Hospital, Afzalgunj, Hyderabad-500012 Hyderabad TELANGANA	9848015098 drkmkreddyp@yahoo.com
Dr Syam Sundar Mukharjee Madivada	Pulse Heart Super Speciality Hospital	Plot#142, Matrusri Cooperative House Building Society, Serilingampally, Ranga Reddy district, 500049, Hyderabad, Telangana, India Hyderabad TELANGANA	98480 14716 drmssm@gmail.com
Dr Arvindkumar Sharma	Rhythm Heart Institute	Near Siddharth Bungalows, Sama-Savli Road, Vadodara- 390022, Gujarat, India Vadodara GUJARAT	9429830260 drarvindcr@gmail.com
Dr Nirmala Castellino	Ruby Hall Clinic	40, Sassoon Road, Pune- 411001, Maharashtra, India Pune MAHARASHTRA	9822008333 nirmalacastellino@hotmail.com
Dr Dinesh Choudhary	S. P. Medical College and AG Hospital	A- Block, Department of Cardiology, S.P. Medical College, Bikaner – 334003, Rajasthan, India Bikaner RAJASTHAN	9414222727 drdineshchoudhary8@gmail.com
Dr Priya Palimkar	Sahyadri Super Speciality Hospital	Survey No.185A, Shastri Nagar, Near MSEB Office, Yerwada, Nagar Road, Pune-411006, Maharashtra, India Pune MAHARASHTRA	9270043039 drpriyapalimkar@gmail.com
Dr Ujwal Kumar	Sarvodaya Hospital and Research Center	Sector 8, Faridabad-121006, Haryana, India Faridabad HARYANA	7042447437 u_kumar1@hotmail.com
Dr Ajay Mahajan	Seth G. S. Medical College and KEM Hospital	Ground Floor, CVTC Building, Department of Cardiology, Acharya Donde Marg, Parel, Mumbai, Maharashtra- 400012 Mumbai MAHARASHTRA	9869032639 drmahajan.kem@gmail.com
Dr Tanuj Bhatia	Shri Guru Ram Rai Institute of Medical and Health Sciences and Shri Mahant Indiresh Hospital	Patel Nagar, Dehradun – 248001, India Dehradun UTTARANCHAL	9936618283 tanujbhatia21@rediffmail.com
Dr Chandrashekhar Patil	Shri Sai Cardiac Centre	2021, B, 6th lane, Rajarampuri, Kolhapur-416008, Maharashtra, India Kolhapur MAHARASHTRA	8147067525 saicardiac.acc@gmail.com
Dr Srinivasu Yalaga	Siddhartha Medical College and Govt General Hospital	Ring Road, Gunadala, Vijayawada – 520008, Andhra Pradesh, India. Krishna ANDHRA PRADESH	8328309714 dr.y.srinivasu@gmail.com
Dr JPS Sawhney	Sir Ganga Ram Hospital	Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Room # F25, First floor, Casualty building, Rajinder Nagar, New Delhi, Delhi - 110060 New Delhi DELHI 110060 India New Delhi DELHI	9810059773 jpssawhney@yahoo.com
Dr Satish Suryavanshi	SMC heart institute and IVF Research centre	VIP estate, Vidhan sabha Road, Infornt of BSNL office, Near Ashoka Ratan shankar Nagar, Raipur, 492007, Chhattisgarh Raipur CHHATTISGARH	9826334404 drsatishsuryavanshi@yahoo.co.in
Dr Balaraju Doddaiah	Sri Jayadeva Institute of Cardiovascular Sciences and Research	Bannerghatta road, Jayanagar 9th block, Bangalore-560069, Karnataka, India Bangalore KARNATAKA	8376906039 Balarajud2000@gmail.com
Dr Nagendra Boopathy Senguttuvan	Sri Ramachandra Hospital	Dental College Basement, Clinical Research Division, Ramachandra Nagar, Porur, Chennai- 600116, Tamil Nadu, India. Chennai TAMIL NADU	7358560284 drsnboopathy@gmail.com
Dr Veerapaneni Sree Ramchandra	Sri Sri Holistic Hospitals	1-2, Nizampet road, Survey 37, Kukatpally, Hyderabad, Telangana, 500090, India Hyderabad TELANGANA	9949033315 ramheart@gmail.com
Dr Muralidharan Thoddi	SRM Medical College Hospital & Research Centre	Centre for Clinical Pharmacology, 3rd Floor– D Block, SRM Nagar, Potheri, Kattankulathur- 603203, Tamil Nadu, India Chennai TAMIL NADU	9500054321 trmuralidharan14@gmail.com
Dr Kiron Varghese	St. Johns Medical College and Hospital	Cardio Research unit, Department of Cardiology, St. Johns Medical College Hospital, Sarjapur road, Koramangala, Bangalore-560034 Bangalore KARNATAKA	9845167912 drkiron@hotmail.com
Dr Mandip Tilara	Sterling Hospital	Plot#251, 150 feet Ring road, Near Raiya Circle, Rajkot-360007, India Rajkot GUJARAT	9825112083 drmandiptilara@gmail.com
Dr Pankaj Harkut	Swasthyam Superspeciality Hospital	Plot No. 97, 98, CTO Staff Co-operative, Housing Society, Vivekanand Nagar, Near Sai Mandir, Wardha Road, Nagpur- 440015, Maharashtra, India Nagpur MAHARASHTRA	9372723376 pankajharkut@rediffmail.com
Dr J Cecily Mary Majella	Tamil Nadu Government Multi Super Speciality Hospital	Tamil Nadu Government Multi Super Speciality Hospital, Omandurar estate, Chennai, Tamil Nadu, India- 600002 Chennai TAMIL NADU	9443584151 drcecilym.research@gmail.com
Dr Ajit Mullasari	The Madras Medical Mission	Main building Lobby room no L01, 4-A, Dr.J.J. Nagar, Mogappair, Chennai-600037,Tamil Nadu, India Chennai TAMIL NADU	04426565974 clireco@mmm.org.in
Dr Deepak Saha	TX Hospitals Private Limited	Block-l:8-2-680/A, Block-2: 8-2-679, Road no.:12, Banjara Hills, Hyderabad, Telangana, 500034, India Hyderabad TELANGANA	9493841512 drdeepaksaha@gmail.com
Dr Devang Desai	Unicare heart institute and Research center	Acme Plaza, B- Wing, Near Sosyo Circle, B/H New Civil Hospital, Canal Road, Surat-395002, Gujarat, India. Surat GUJARAT	9825117900 hridayamHeartcare@gmail.com
Dr Vikrant Vijan	Vijan Hospital & Research Centre	Dr. Vijan Hospital Marg, College Road, Nashik-422005, Maharashtra, India Nashik MAHARASHTRA	9539681750 dr.vijan.research@gmail.com
Dr Hemant Kokane	WMF’S Villloo Poonawalla Memorial Hospital	S.No.156, Soli Poonawalla Road (Solapur), Hadapsar, Pune-411028, Maharashtra, India Pune MAHARASHTRA	9619284398 hemantkokane@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 87
Name of Committee	Approval Status
Arnejas Institutional Ethics Committee	Approved
Ashirwad Ethics Committee	Approved
Central Ethics Committee Nitte Deemed To Be University	Approved
Crescent Hospital Institutional Ethics Committee	Approved
EPIC Hospital Ethics Committee	Approved
Ethics Committee Inamdar Multispecialty Hospital	Approved
Ethics Committee of All India Heart Foundation	Approved
Ethics Committee of CIMS	Approved
Ethics Committee of Crescent Hospital Heart Centre	Approved
Ethics Committee of Kamalnayan Bajaj Hospital	Approved
Ethics Committee S P Medical College Bikaner	Approved
Ethics Committee Sir Ganga Ram Hospital	Approved
IEC Columbia Asia Hospital Mysore	Approved
IEC Intervention Studies JIPMER Pondicherry	Approved
IEC JIPMER	Approved
IEC King George hospital	Approved
IEC TNMC Nair Hospital	Approved
Institute Ethics Committee	Approved
Institution Ethics Committee SGRRIM & HS	Approved
Institutional Ethic Committee Medicover Hospitals	Approved
Institutional Ethics Committee	Approved
Institutional Ethics Committee AIIMS Bhubaneswar	Approved
Institutional Ethics Committee Apex Hospital Pvt Ltd	Approved
Institutional Ethics Committee BVDU	Approved
Institutional Ethics Committee Charak Hospital and Research Centre	Approved
Institutional Ethics Committee Dr Ram Manohar Lohia Institute of Medical Sciences	Approved
Institutional Ethics Committee ESIC Medical College & Hospital	Approved
Institutional Ethics Committee for Sahyadri Hospital	Approved
Institutional Ethics Committee Fortis Escorts Heart Institute	Approved
Institutional Ethics Committee Fortis Hospital	Approved
Institutional Ethics Committee GCS Medical College	Approved
Institutional Ethics Committee Govt Medical College & Govt General Hospital	Approved
Institutional Ethics Committee Govt Medical College Kozhikode	Approved
Institutional Ethics Committee IGMC Shimla	Approved
Institutional Ethics Committee Indira Gandhi Institute Of Medical Sciences	Approved
Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital	Approved
Institutional Ethics Committee K G Hospital K Govindaswamy Naidu Medical Trust	Approved
Institutional Ethics Committee King Georges Medical University	Approved
Institutional Ethics Committee Kurnool Medical College	Approved
Institutional Ethics Committee Lisie Hospital	Approved
Institutional Ethics Committee Maulana Azad Medical College	Approved
Institutional Ethics Committee Max Super Specialty Hospital	Approved
Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre	Approved
Institutional Ethics Committee MLN Medical College	Approved
Institutional Ethics Committee Osmania medical College	Approved
Institutional Ethics Committee Sarvodaya Hospital and Research Centre	Approved
Institutional Ethics Committee Siddhartha Medical College and Govt General Hospital	Approved
Institutional Ethics Committee Sree Ramchandra Health Services	Approved
INSTITUTIONAL ETHICS COMMITTEE SRIHER	Approved
Institutional Ethics Committee SRM Medical College Hospital and Research Centre	Approved
Institutional Ethics Committee St Johns Medical College Hospital	Approved
Institutional Ethics Committee The Madras Medical Mission	Approved
Institutional Ethics Committee TX Hospitals	Approved
Institutional Ethics Committee WMFs Villoo Poonawalla Memorial Hospital	Approved
Institutional Ethics Committee, AIIMS, Bathinda	Approved
Institutional Ethics Committee, Devki Devi Foundation	Approved
Institutional Ethics Committee, KLE Universit	Approved
Institutional Ethics Committee, TNGMSSH	Approved
Institutional Ethics Committee-I Seth GS Medical College and KEM Hospital	Approved
Institutional Human Ethics Committee, All India Institute of Medical Sciences	Approved
IPGMEandR Research Oversight Committee	Approved
Jupiter Hospital and Research Centre Institutional Ethics Committee	Approved
KEM Hospital Research Centre Ethics Committee	Approved
KIMS Ethics Committee	Approved
Kiran Hospital Ethics Committee	Approved
Lakeshore Ethics Committee	Approved
Lakeview Ethics Committee	Approved
Lalitha Super Specialties Hospital Ethics Committee	Approved
lnstitutional Ethics Committee Amrita lnstitute of Medical Sciences	Approved
Magna Care Ethics Committee	Approved
MAHE Ethics Committee	Approved
Malla Reddy Medical College for Women Institutional Ethics Committee	Approved
Medanta Institutional Ethics Committee	Approved
MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECT	Approved
Narayana Health Medical Ethics Committee	Approved
Nirmal Hospital Ethics Committee	Approved
Poona Medical Research Foundation	Approved
Pulse Heart Super Speciality Hospital Institutional Ethics Committee	Approved
Rhythm Heart Institute Ethics Committee	Approved
Scientific Research and Ethical Review Committee	Approved
Shreyas Hospital Institutional Ethics Committee	Approved
SMC Heart Institute Institutional Ethics Committee	Approved
Sri Jayadeva Ethics Committee	Approved
Sterling Institutional Ethics Committee	Approved
Swasthyam Ethics Committee	Approved
Unity Hospital Ethics Committee	Approved
VIJAN HOSPITAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I213\|\|ST elevation (STEMI) myocardial infarction of unspecified site,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Placebo	Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI.
Intervention	Selatogrel	Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI. Other Names: • ACT-246475

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Confirmed diagnosis of symptomatic type 1 AMI STEMI or NSTEMI, no longer than 4 weeks prior to randomization.

ExclusionCriteria

Details

Chronic anemia with hemoglobin less than 10 g per dL.
Chronic thrombocytopenia with platelet count less than 100,000 per mm3.
Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Centralized

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome

TimePoints

1. Clinical status as assessed by a 6-point ordinal scale
1. Death (all causes), within 7 days after study treatment administration.
2. AMI with compromised electro-hemodynamics, within 2 days after study treatment administration.
3. STEMI, within 2 days after study treatment administration.
4. High-risk NSTEMI, within 2 days after study treatment administration.
5. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration.
6. None of the above

Time Frame: Total duration: up to 7 days

Secondary Outcome

Outcome	TimePoints
Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint) within 30 days after any self-administration	Time Frame: Total duration: up to 30 days

Target Sample Size

Total Sample Size="14000"
Sample Size from India="2500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

30/06/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

16/08/2021

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="4"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

The purpose of this study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in participants at risk of having a recurrent AMI.