| CTRI Number |
CTRI/2008/091/000018 [Registered on: 13/02/2008] |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
A clinical trial to study the safety and efficacy of a new drug biotinylated idraparinux (SSR126517E) as compared to another drug warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillation |
Scientific Title of Study
Modification(s)
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A multicenter, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR126517E) with adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillation |
| Trial Acronym |
BOREALIS AF |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC10295 |
Protocol Number |
| NCT00580216 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Salini James |
| Designation |
|
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
A-101 Business Square,
Sir Mathuradas Vasanji Marg,
Chakala, Andheri East, MUMBAI-400 093 – INDIA
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912230707820 |
| Fax |
912230707844 |
| Email |
salini.james@sanofi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Salini James |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
A-101 Business Square, Sir Mathuradas Vasanji Marg,
Chakala, Andheri East, MUMBAI-400 093 – INDIA
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912230707820 |
| Fax |
912230707844 |
| Email |
salini.james@sanofi.com |
|
Source of Monetary or Material Support
Modification(s)
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| Sanofi-Synthelabo (India) Limited
54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai 400093
|
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Primary Sponsor
Modification(s)
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| Name |
SanofiSynthelabo India Limited |
| Address |
54/A, Sir Mathuradas Vasanji Marg,Chakala, Andheri East, MUMBAI-400 093 – INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
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Indonesia
India
Thailand
Argentina
Australia
Austria
Belarus
Brazil
Bulgaria
Canada
Chile
Colombia
Costa Rica
Croatia
Czech Republic
Denmark
Egypt
Estonia
Finland
France
Greece
Guatemala
Israel
Italy
Lithuania
Malaysia
Mexico
Morocco
Netherlands
New Zealand
Norway
Other
Panama
Peru
Poland
Portugal
Republic of Korea
Russian Federation
Slovakia
South Africa
Spain
Sweden
Taiwan
Turkey
Ukraine
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Naik |
The Heart Care Clinic |
201, Balleshwar Avenue, Opp. Rajpath Club, Sarkhej-Gandhinagar Highway, Opp. Rajpath Club, Ahmedabad- - 380 054
Ahmadabad
GUJARAT |
9825082666
naikajay@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Safe Search Independent Ethics Committee, Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Atrial fibrillation , (1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Biotinylated Idraparinux & Avidin |
3mg/week for initial 7 weeks and thereafter 1.5mg/week or 2mg/week depending on renal clearance.Minimum 6 months; maximum 2.5 years |
| Comparator Agent |
Warfarin |
Dose adjustment will be based on INR reading ; Minimum 6 months; maximum 2.5 years |
|
Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Permanent, persistent or paroxysmal non-valvular atrial fibrillation that is ECG-documented
2. With an indication for long-term VKA therapy based on the presence of previous ischemic stroke, TIA or systemic embolism; and/or at least two of the following risk factors
(1) hypertension requiring drug treatment; (2) moderately or severely impaired left ventricular function and/or congestive heart failure; (3) age > 75 years; (4) diabetes mellitus |
|
| ExclusionCriteria |
| Details |
1. Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism.
2. Stroke within previous 5 days or transient ischemic attack within previous 5 days.
3. Transient AF caused by a reversible disorder.
4. Planned major surgery or cardioversion within 30 days.
5. INR > 3 at baseline.
6. Uncontrolled hypertension: systolic blood pressure > 180 mm Hg &/or diastolic blood pressure > 110 mm Hg.
7. Active bleeding or high risk of bleeding
8. Pregnant or childbearing potential without proper contraceptive measures or breast feeding.
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| composite of all strokes or non central nervous system (CNS) systemic embolic events (SE) |
End of study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| separate components of the primary study outcome |
end of study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="9600"
Sample Size from India="94"
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
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
13/02/2008 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/12/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
Clincal Study Report |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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Trial will be conducted in 48 countries all over the world The Indian target - 94 patients Indian status - No patients randomized till date Planned date of first enrolment - 28th Feb 2008
A total of 3773 patients were randomized globally. In India, study was initiated at 18 study centers; and 72 patients were enrolled at these centers.
This study has been prematurily terminated. |