Protocol CV185030: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillatio

Phase 3

Completed

• Conditions: atrial fibrillation; 10007521

• Registration Number: NL-OMON35379
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 252

Inclusion Criteria

1) Age >= 18 years
2) In atrial fibrillation or atrial flutter not due to reversible cause and documented by ECG at the time of enrollment OR If not in atrial fibrillation/flutter at the time of enrollment, must have atrial fibrillation/flutter documented on two separate occasions, not due to a reversible cause at least 2 weeks apart in the 12 months prior to enrollment.
3) One or more of the following risk factor(s) for stroke: a) Age 75 years or older, b) prior stroke, TIA or systemic embolus, c) Either symptomatic congestive heart failure within 3 months or left ventricular dysfunction with an LV ejection fraction (LVEF) <= 40%, d) Diabetes mellitus, e) hypertension requiring pharmacological treatment.

Exclusion Criteria

1) Atrial fibrillation or flutter due to reversible causes.
2) Clinically significant mitral stenosis
3) Increased bleeding risk that is believed to be a contraindication to oral anticoagulation.
4) Conditions other than atrial fibrillation that require chronic anticoagulation.
5) Persistent, uncontrolled hypertension (systolic BP > 180 mmHg of diastolic BP > 100 mm Hg).
6) Active infective endocarditis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary efficacy endpoint: The primary efficacy endpoint is the time to first<br /><br>occurrence of confirmed stroke (ischemic or non-ischemic) or systemic embolism,<br /><br>regardless of whether the subject is receiving treatment at the time of event.<br /><br>Primary safety endpoint: The primary safety endpoint will be time to first<br /><br>occurrence of confirmed major bleeding during the treatment period or 30 days<br /><br>post-treatment if the event is a SAE.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary efficacy endpoints will be: time to first occurrence of<br /><br>confirmed: ischemic stroke, hemorrhagic stroke, systemic embolism, all cause<br /><br>death and the composite of the combinations of all of these indications.<br /><br>Secondary safety endpoints is a composite of confirmed major bleeding and<br /><br>confirmed clinically relevant non-major bleeding.</p><br>