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 fibrillatio

Phase 3

• Conditions: Health Condition 1: null- Atrial fibrillationHealth Condition 2: I489- Unspecified atrial fibrillation and atrial flutter

• Registration Number: CTRI/2008/091/000018
• Lead Sponsor: SanofiSynthelabo India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 9600

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified