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CTRI Number  CTRI/2023/10/058195 [Registered on: 03/10/2023] Trial Registered Prospectively
Last Modified On: 19/12/2023
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 study to learn how well the study treatment asundexian works and how safe it is compared to apixaban to prevent strokeor systemic embolism in people with irregular and often rapid heartbeat (atrial fibrillation), and at risk for stroke 
Scientific Title of Study   A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke 
Trial Acronym  OCEANIC-AF 
Secondary IDs if Any  
Secondary ID  Identifier 
141805  ClinicalTrials.gov 
19767 Version 1 dated 06 Jan 2023  Protocol Number 
2022-000758-28  EudraCT 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J P S Sawhney  
Designation  National Lead Investigator 
Affiliation  Sir Ganga Ram Hospital  
Address  Sir Ganga Ram Hospital Chairman - Department of Cardiology, Old Rajinder Nagar, New Delhi

North East
DELHI
110060
India 
Phone    
Fax    
Email  jpssawhney@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Anand Pendse 
Designation  Country Lead Monitor 
Affiliation  Bayer Pharmaceuticals Private Limited.  
Address  Pharmaceuticals Division, Research & Development, Pharmaceuticals Bayer House, Central Avenue, Hiranandani Estate, Thane.

Thane
MAHARASHTRA
400607
India 
Phone  9820563905  
Fax    
Email  anand.pendse@bayer.com  
 
Details of Contact Person
Public Query  
Name  Anand Pendse 
Designation  Country Lead Monitor 
Affiliation  Bayer Pharmaceuticals Private Limited.  
Address  Pharmaceuticals Division, Research & Development, Pharmaceuticals Bayer House, Central Avenue, Hiranandani Estate, Thane.

Thane
MAHARASHTRA
400607
India 
Phone  9820563905  
Fax    
Email  anand.pendse@bayer.com  
 
Source of Monetary or Material Support  
Bayer AG, 51368 Leverkusen, Germany. 
 
Primary Sponsor  
Name  Bayer Pharmaceuticals Private Limited 
Address  Pharmaceuticals Division, Research & Development, Pharmaceuticals Bayer House, Central Avenue, Hiranandani Estate, Thane : 400607. Maharashtra, India.  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Colombia
Czech Republic
Democratic People's Republic of Korea
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Latvia
Lithuania
Malaysia
Netherlands
New Zealand
Norway
Philippines
Portugal
Republic of Korea
Singapore
Slovakia
Spain
Switzerland
Taiwan
Turkey
Ukraine
United Kingdom  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sankar Chandra Mondal   IPGMER and SSKM Hospital  Department of Cardiology Ground Floor OPD 244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL 		 9433009582

drscmandal5@gmail.com 
Dr Milind Gadkari   KEM Hospital and Research Center  KEM Hospital, 5th floor, Diamond Jubilee Building, Sardar Moodliar Road, Rasta Peth, Pune-411011.
Pune
MAHARASHTRA 		 91-9763888656

gadkaris@gmail.com 
Dr Jabir Abdullakutty   Lisie Hospital  Department of Cardiology OPD First Floor Lisie Hospital P O Box 3053 Kochi 682018
Ernakulam
KERALA 		 9447011773

drjabi@yahoo.co.in 
Dr Atul Abhyankar  Shri B D Mahavir Heart Institute  Shree Mahavir Health Campus OPD Area Ground Floor Athwa Gate Ring Road Surat 395001
Surat
GUJARAT 		 9824145738

atulda@hotmail.com 
Dr J P S Sawhney   Sir Ganga Ram Hospital  Department of Cardiology Sir Ganga Ram Hospital 5th floor Sir Ganga Ram Hospital Marg Rajinder Nagar New Delhi 110060
North East
DELHI 		 9810059773

jpssawhney@yahoo.com 
Dr Vinod Vijan   Vijan Hospital and Research Center  Ground Floor OPD Vijan Hospital and Research Center Dr Vijan Hospital Marg HPT College Road Nashik 422005
Nashik
MAHARASHTRA 		 9822025353

dr.vijan.research@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
EC of Care Institute of Medical Sciences  Approved 
IEC Asian Institute of Gastroenterology  Approved 
Institutional Ethics Committee Lisie Hospital  Approved 
IPGME&R Research Oversight Committee  Approved 
KEM HOSPITAL Research Centre Ethics Committee  Approved 
Shri B.D. Mehta Mahavir Heart Institute Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Approved 
Vijan Hospital Ethics Committee Vijan Cardiac and Critical Care Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I482||Chronic atrial fibrillation. Ayurveda Condition: Atrial Fibrillation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent.

2. Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant.

3. CHA2DS2-VASc score ≥ 3 if male or ≥ 4 if female,
OR
CHA2DS2-VASc score of 2 if male or 3 if female and
enrichment criteria. 
 
ExclusionCriteria 
Details  1. Mechanical heart valve prosthesis

2. Moderate-to-severe mitral stenosis at the time of inclusion into the study

3. Atrial fibrillation only due to reversible cause

4. Requirement for chronic anticoagulation for a different indication than atrial fibrillation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Time to first occurrence of composite of stroke or systemic embolism

 		 Up to 34 months 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first occurrence of composite of ischemic stroke or systemic embolism  Up to 34 months 
Time to first occurrence of all-cause mortality  Up to 34 months 
Time to first occurrence of ischemic stroke  Up to 34 months 
Time to first occurrence of cardiovascular (CV) death  Up to 34 months 
Time to first occurrence of composite of CV death, stroke, or myocardial infarction  Up to 34 months 
Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding  Up to 34 months 
Time to first occurrence of clinically relevant non-major bleeding  Up to 34 months 
Time to first occurrence of hemorrhagic stroke  Up to 34 months 
Time to first occurrence of intracranial hemorrhage  Up to 34 months 
Time to first occurrence of fatal bleeding  Up to 34 months 
Time to first occurrence of minor bleeding  Up to 34 months 
Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality  Up to 34 months 
Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) ≥ 3), critical bleeding, or all-cause mortality  Up to 34 months 
 
Target Sample Size   Total Sample Size="18000"
Sample Size from India="100" 
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)   10/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/12/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
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  
Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with increased rates of death, stroke and other thromboembolic events. 
Current treatment guidelines recommend the use of long-term oral anticoagulant therapy such as VKAs, or NOACs in patients with AF at risk for stroke. 
This pivotal Phase 3 study will evaluate the efficacy and safety of asundexian compared with apixaban for the prevention of stroke or systemic embolism in participants with atrial fibrillation. 
Asundexian, as an oral FXIa inhibitor, is expected to show a benefit in reducing the risk for stroke or systemic embolism in patients with AF in Phase 3.
Asundexian is therefore an attractive candidate to be evaluated as a potential replacement for NOAC therapy in patients with AF.
In conclusion, asundexian is believed to represent a potentially improved new therapeutic option for thrombosis prevention in life-threatening thrombotic diseases with superior bleeding safety compared to oral anticoagulants and without a significant increase in bleeding risk on top of available antiplatelet therapy.
 
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