Patent Foramen Ovale in Cryptogenic Stroke Study

• Status: Completed
• Trial end date: 2000-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Aspirin; Warfarin

Criteria

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