Patent Foramen Ovale in Cryptogenic Stroke Study

Phase 4

Completed

• Conditions: Ischemic Stroke; Patent Foramen Ovale
• Interventions: Drug: Warfarin; Drug: Aspirin

• Registration Number: NCT00697151
• Lead Sponsor: Columbia University

Brief Summary

The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-06
• Primary Completion: 2000-06
• Study Completion: 2000-06
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-13
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-14
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• Age 30-85
• Ischemic stroke within 30 days
• Glasgow outcome scale ≥ 3
• No contraindications to warfarin/aspirin

Exclusion Criteria

• Basal INR > 1.4
• Post-procedural stroke
• Severe carotid atherosclerosis
• Cardioembolic stroke
• Contraindications to transesophageal echocardiography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warfarin	Warfarin	Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin
Aspirin	Aspirin	Aspirin 325 mg plus placebo warfarin

Primary Outcome Measures

Name	Time	Method
Recurrent ischemic stroke and death	2 years

Trial Locations

Locations (1)

Columbia College of Physicians and Surgeons; 🇺🇸 New York, New York, United States