Study to evaluate whether or not abelacimab is safe and effective in preventing stroke in patients with atrial fibrillation who are considered as high risk of stroke, but who have been deemed to be unsuitable candidates for currently available oral anticoagulants.
Scientific Title of Study
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaluate the efficacy and Safety of abelacimab in High-risk Patients with Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral anticoagulation (LILAC).
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shekhar Dawkhar
Designation
Senior Director
Affiliation
Fortrea Development India Private Limited
Address
Fortrea Development India Private Limited, Building No.1, Unit No. 601, Raheja Mindspace,
Plot Nos. Gen2-1-D,E,F, MIDCTTC, Shiravane, Navi Mumbai
Thane MAHARASHTRA 400706 India
Phone
7506653414
Fax
Email
shekhar.dawkhar@fortrea.com
Details of Contact Person Scientific Query
Name
Dr Shekhar Dawkhar
Designation
Senior Director
Affiliation
Fortrea Development India Private Limited
Address
Fortrea Development India Private Limited, Building No.1, Unit No. 601, Raheja Mindspace,
Plot Nos. Gen2-1-D,E,F, MIDCTTC, Shiravane, Navi Mumbai
Thane MAHARASHTRA 400706 India
Phone
7506653414
Fax
Email
shekhar.dawkhar@fortrea.com
Details of Contact Person Public Query
Name
Dr Shekhar Dawkhar
Designation
Senior Director
Affiliation
Fortrea Development India Private Limited
Address
Fortrea Development India Private Limited, Building No.1, Unit No. 601, Raheja Mindspace,
Plot Nos. Gen2-1-D,E,F, MIDCTTC, Shiravane, Navi Mumbai
Thane MAHARASHTRA 400706 India
Phone
7506653414
Fax
Email
shekhar.dawkhar@fortrea.com
Source of Monetary or Material Support
Fortrea Development India Private Limited
Primary Sponsor
Name
Anthos Therapeutics Inc
Address
55 Cambridge Pkwy, Ste. 103 Cambridge, MA 02142
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Fortrea Development India Private Limited Building No Unit No Raheja Mindspace
Fortrea Development India Private Limited, Building No.1, Unit No. 601, Raheja Mindspace,
Plot Nos. Gen_2_1_D,E,F, MIDCTTC, Shiravane, Navi Mumbai
Countries of Recruitment
Argentina Brazil Bulgaria Canada Chile China Czech Republic Estonia Germany Hungary India Israel Italy Japan Latvia Mexico Poland Romania Spain United Kingdom United States of America
Room No. 217, 2nd floor, Department of Cardiology, Sijua, Patrpada, Dumduma, 751019 Khordha ORISSA
9491634156
cardio_ramachandra@aiimsbhubaneswar.edu.in
Dr Rakesh Yadav
AIIMS, New Delhi (Site# 2319)
Department of Cardiology, CN Centre, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 New Delhi DELHI
9868026888
rakeshyadav123@yahoo.com
Dr Jaideep Channayil Menon
Amrita Institute of Medical Sciences (AIMS) and Research Centre (Site#2304)
Department of Cardiology, Tower A, 5th floor, AIMS, Ponekkara, Kochi, 682041 Ernakulam KERALA
9895122099
menon7jc@gmail.com
Dr Jaspalsingh Arneja
Arneja Heart and Multispeciality Hospital (Site# 2336)
123, Ramdaspeth, Nagpur - 440010, Maharashtra, India. Nagpur MAHARASHTRA
9823066007
jaspalarneja_200@yahoo.com
Dr Daljeet Kaur Saggu
Asian Institute of Gastroenterology (Site#2333)
Mind Space Road, Gachibowli - 500032 Hyderabad TELANGANA
8978428938 91-40-23324255 info@aighospitals.com
Dr Divyaprakash Mada
Bangalore Medical College and Research Institute (Site#2311)
2nd floor, department of cardiology, BMCRI, Superspecialty Hospital, Victoria Hospital Campus, Fort, K. R. Road, Bangalore, 560002, Bangalore KARNATAKA
9113030135
drdivyaprakashbmc@gmail.com
Dr Gurpreet S Wander
Dayanand Medical College & Hospital (Site #2323)
Unit Hero DMC Heart Institute, Tagore Nagar, Civil Lines, Ludhiana - 141001, Punjab, India. Ludhiana PUNJAB
9815545316
drgswander@yahoo.com
Dr Prashant R Mishra
Deenanath Mangeshkar Hospital & Research Centre (Site#2305)
Super Speciality building, 2nd floor, Cardiology department, Erandwane, Pune, 411004 Pune MAHARASHTRA
9890090555
prashantmishra@gmail.com
Dr Bhagya Narayan Pandit
Dr. Ram Manohar Lohia Hospital (Site#2307)
Clinical Research Department, Ground floor, CCU building, Gate No. 6, ABVIMS, Baba Kharak Singh Marg, New Delhi – 110002 New Delhi DELHI
9350188470
bnpandit1977@gmail.com
Dr Pradeep Pereira
Father Muller Medical College Hospital (Site #2326)
Father Muller Road, Kankanady, Mangalore, Karnataka – 575002, India. Dakshina Kannada KARNATAKA
9483161460
pradeeppmed@gmail.com
Dr Girish MP
G.B Pant Institute of Post Graduate Medical Education and Research (Site#2301)
D-block, 6th floor, Research room, 1 Jawahar Lal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi, 110002 New Delhi DELHI
9891117573
girishpalleda@gmail.com
Dr Selvakumar Chinnakkannan
Geri Care Hospitals (Site#2338)
No.8, Dr. Nair Road, Behind Vani Mahal T Nagar, Chennai - 600017, Tamil Nadu, India. Chennai TAMIL NADU
9840978491
gccri@gericare.in
Dr Sunil N Washimkar
Government Medical College & Superspeciality Hospital (Site#2302)
Kala Bagh, Ajmer, Rajasthan – 305001, India Ajmer RAJASTHAN
9829290725
doctor.pramodpareek@gmail.com
Dr Rishi Lohiya
KIMS - Kingsway Hospital (Site#2315)
Room No 207, Second Floor, Cardiology Department, 44, Kingsway Rd, Near Kasturchand Park, Nagpur, 440001 Nagpur MAHARASHTRA
9320181115
drrvlohiya@gmail.com
Dr Jenny Madhuri Gudivada
King George Hospital (Site#2321)
Department of Cardiology, King George Hospital, Andhra Medical College, Maharanipeta, Visakhapatnam- 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9573472413
drjennymadhuriresearch@gmail.com
Dr Anand Kumar Valsakumar
Lakeshore Hospital and Research Centre Ltd (Site#2340)
24/477, Maradu, Nettoor P.O, Kochi - 682040 Ernakulam KERALA
Sir Ganga Ram Hospital Ethics Committee (Site# 2322)
Approved
Viveka Hospital Ethics Committee (Site#2316)
Approved
Zydus Hospital Ethics Committee (Site#2310)
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Abelacimab 150 mg per mL
Abelacimab 150 mg per mL provided as liquid in vial once monthly for up to 24 months.
Comparator Agent
Placebo to Abelacimab
Placebo to Abelacimab to be provided as liquid in vial once monthly for up to 24 months.
Inclusion Criteria
Age From
65.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Patient is able to understand and willing to provide written informed consent to participate in the trial
Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
Age 65-74 and a CHA2DS2VASc ≥5 OR age ≥75 and a CHA2DS2VASc ≥4
Judged by the responsible physician or by their own decision to be unsuitable for oral anticoagulation
At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls
ExclusionCriteria
Details
AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 60 days prior to randomization
Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c slash 5 bleeding
Efficacy: Up to 30 months
Safety: Up to 30 months
Secondary Outcome
Outcome
TimePoints
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia
Up to 30 months
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c slash 5 bleeding event
Up to 30 months
Efficacy: Cardiovascular (CV) mortality
Up to 30 months
Efficacy: All-cause mortality
Up to 30 months
Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Up to 30 months
Target Sample Size
Total Sample Size="1900" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.