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CTRI Number  CTRI/2016/09/007230 [Registered on: 01/09/2016] Trial Registered Prospectively
Last Modified On: 14/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative clinical trial to understand efficacy and safety of R-TPR-012/ Metalyse® in Patients with heart attack 
Scientific Title of Study   Prospective, multi-centre, randomized, two-arm, parallel group, active-control, comparative clinical study to evaluate efficacy and safety of R-TPR-012/ Metalyse® in Patients with ST segment elevation Myocardial Infarction (STEMI) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/CAD/2015/02_Version 2_18 Aug 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parvez Kosgi 
Designation  Head RLS clinical Trial 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai Thane MAHARASHTRA

Thane
MAHARASHTRA
400701
India 
Phone  02240678000  
Fax  02240678299  
Email  parvez.kosgi@relbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashank Deoghare 
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai Thane MAHARASHTRA

Thane
MAHARASHTRA
400701
India 
Phone  02240678000  
Fax  02240678299  
Email  shashank.deoghare@relbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Jay Madkaikar 
Designation  Project Manager 
Affiliation  Reliance Life Sciences Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai Thane MAHARASHTRA

Thane
MAHARASHTRA
400701
India 
Phone  02240678000  
Fax  02240678299  
Email  jay.madkaikar@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India 
 
Primary Sponsor  
Name  Reliance Life sciences Pvt Ltd 
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arneja Jaspal Singh  Arneja Heart and Multispeciality Hospital  Arneja Heart and Multispeciality Hospital Plot No. 123, Behind Somalwar High School, Ramdaspeth, Nagpur 440010, Maharashtra
Nagpur
MAHARASHTRA 		 7122450539

jaspalarneja_200@yahoo.com 
Dr Manojkumar Chopda  Chopda Medicare & Research Centre Pvt Ltd  Chopda Medicare & Research Centre Pvt Ltd, Plot No. 3/5, Laxmi Nagar, Patil Lane No 1,Near K B H Vidyalaya, Opp Vasant Market,Canada Corner, Nashik 422005 Maharashtra, India
Nashik
MAHARASHTRA 		 912532316200

Rush_manoj@yahoo.com 
Dr K Sambasivam  Dr. K Sambasivam  G. Kuppuswamy Naidu Memorial Hospital P.B. No. 6327, Nethaji Road, Pappanaickenpalayam, Coimbatore - 641 037
Coimbatore
TAMIL NADU 		 04224305327

drsambasivam@yahoo.com 
Dr Sethuraman Selvamani  Dr. Sethuraman Selvamani  Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai, Tamil Nadu India 625107
Madurai
TAMIL NADU 		 9104522586353

maniselva@hotmail.com 
DrAshok Bhupali  Dr.Ashok Bhupali  Apple Saraswati Multispeciality Hospital804/2,805/2,E ward,Circuit House To KadamwadiRoad, Bhosalewadi, Kolhapur – 416003
Kolhapur
MAHARASHTRA 		 2688888

abhupali@gmail.com 
DrKokane  Dr.Hemant Kokane  BJ Medical College and Sassoon Hospital,Jai Prakash Narayan Road, Near Pune Railway Station
Pune
MAHARASHTRA 		 02026130991

hemantkokane@gmail.com 
DrRony Mathew  Dr.Rony Mathew  Lisie Hospital, Lisie Pullepady Road, Kochi
Ernakulam
KERALA 		 48424011102

drronymathew@yahoo.com 
DrSachin Patil  Dr.Sachin Patil  Aster Aadhar Hospital, Kolhapur
Kolhapur
MAHARASHTRA 		 02316622555

sachinpatil.aacr@gmail.com 
DrVikas Agarwal  G.V. Meditech Private Limited  G.V. Meditech Private Limited, B 38/46-H, Raman Niwas, Mahmoorganj, Varanasi- 221010 India
Varanasi
UTTAR PRADESH 		 919621975232

Drvikasmed@gmail.com 
Dr Shailendra Ganjewar  Meditrina Institute of Medical Sciences  Meditrina Institute of Medical Sciences Director Cath Lab Meditrina Institute of Medical Sciences, Nagpur 440010 Maharashtra, India
Nagpur
MAHARASHTRA 		 07126669672

asganjewar@yahoo.com 
Dr Narendra Jathappa  Nanjappa Life Care  Nanjappa Life Care #5619, Gadikoppa, Sagar Road, Shivamogga - 577205, Karnataka, India
Shimoga
KARNATAKA 		 08182-225085

jnarendra2009@gmail.com 
Dr Mukund Kumbla  Omega hospital  Omega hospital, First Floor,Mahaveer Circle, Kankanady, Mangalore-575002, India
Dakshina Kannada
KARNATAKA 		 0824-2430000

omegahospital@bsnl.in 
Dr Pothineni Ramesh Babu  Ramesh Hospitals  Ramesh Hospitals, Ring Road, Near ITI College Vijayawada 520008 Andhra Pradesh, India
Vizianagaram
ANDHRA PRADESH 		 8662486094

rameshbabup@rameshhospitals.com 
Dr Abhijeet Palshikar  Sahyadri Speciality Hospital  Sahyadri Speciality Hospital, 30 C, Erandwane, Karve Road, Pune 411004 Maharashtra, India
Pune
MAHARASHTRA 		 02025459117

dr_abhijeet@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Apple Saraswati Multispeciality Hospital Institutional Ethical Committee  Approved 
GV Meditech Ethics Committee  Approved 
IEC Lisie Hospital  Approved 
Institutional Ethics Committe, Ramesh Hospital  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee,Arneja Hospital  Approved 
Magna Care Ethics Committee  Approved 
Meditrina Insitution Ethics Commitee  Approved 
Meenakshi Mission Hospital & Research Centre  Approved 
Nanjappas Insitutional Ethics Commitee  Approved 
Omega Ethical Committee  Approved 
Sahyadri Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with ST segment elevation Myocardial Infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metalyse(R)  Administered as per the body weight Intravenously as bolus, single dose 
Intervention  R-TPR-012  Administered as per the body weight Intravenously as bolus, single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female subjects in the range of 18 to 65 years of age (inclusive).
2. Subjects presenting with chest pain and/or equivalent symptoms and diagnosis of Acute Myocardial Infarction confirmed by physician along with following ECG changes (12 lead).
 ST elevation of ≥ 0.1 mV in two or more limb leads or
 ST elevation of ≥ 0.2 mV in two or more contiguous precordial leads
3. Subjects presenting with AMI within 6 hours of occurrence of symptoms.
4. Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures.
5. Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained to confirm his/her willingness to continue in the study
6. Subjects must be able to adhere to the study visit schedule and other protocol requirements. 
 
ExclusionCriteria 
Details  1. Subjects with Left Bundle Branch Block (LBBB).
2. History of contraindication to the use of thrombolytics.
3. Internal active bleeding or known history of hemorrhagic diathesis.
4. Any known history of haemorrhagic stroke or stroke of unknown origin
5. Any history of ischaemic stroke or transient ischaemic attack in the preceding 6 months
6. History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, major surgery, parenchymal biopsy, ocular surgery and/or significant trauma within the past 2 months (this includes any trauma associated with the current AMI).
7. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to screening for study.
8. Confirmed arterial hypertension of systolic BP 200 mm Hg and diastolic BP 110 mm Hg at entry which does not respond rapidly to treatment.
9. Cardiogenic shock (Systolic BP 60 mm Hg)
10. Administration of Tenecteplase in the last 14 days prior to screening for study.
11. Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hrs prior to screening for study.
12. Subjects on oral anticoagulant treatment.
13. Suspected AMI secondary to occlusion of one lesion treated previously with a per-cutaneous coronary intervention.
14. Suspicion of aortic dissection.
15. Subjects with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction.
16. Pregnant and lactating females.
17. Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis (based on history and examination)
18. Any other condition like active peptic ulceration, acute pancreatitis, which investigator feels would pose a significant hazard to subject if IP is administered
19. High risk subjects as per TIMI risk scoring. Such patients can be included after discussion with medical monitor, if investigator feels the study treatment as best possible option available for the subject.
20. Participation in any clinical study of an investigational product within the previous 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy endpoint will be rate of TIMI 3 flow (Thrombolysis In Myocardial Infarction) of the infarct related artery at 90 minutes and all-cause mortality rate at 30 days post dosing in subjects with STEMI following treatment with R-TPR-012/Metalyse  30 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
1. 50% resolution of elevated ST segment
2. Events of myocardial re-infarction(s)
3. Changes in left ventricular ejection fraction assessed by Echocardiography
4. Events of ventricular tachyarrhythmias
5. All-cause mortality rate at 6 months and 1 year post dosing considering the day of dosing as day 0
6. Change from baseline in cardiac enzymes level
7. Pharmacokinetic parameters assessment
8. Immunogenicity assessment
9. Safety 		 30 days 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   02/09/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 

This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study.











STEMI



The study is

to determine whether R-TPR-012 (Tenecteplase) is comparable to Metalyse® in efficacy as determined by TIMI (Thrombolysis In Myocardial Infarction) perfusion grades  and all-cause mortality rate at 30 days post dosing in subjects with STEMI following treatment with R-TPR-012/Metalyse®.


 
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