Patent Foramen Ovale in Cryptogenic Stroke Study

Completed · Phase 4 · Has a placebo group

Conditions studied: Ischemic Stroke, Patent Foramen Ovale

In brief

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.

Key facts

Study ID

NCT00697151

Run by

Columbia University

People needed

630

Starts

1993-06-01

Expected to finish

2000-06-01

Last updated by the study team

2011-09-15

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Columbia College of Physicians and Surgeons — New York, New York, United States

Full record on ClinicalTrials.gov

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