Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

Columbia University

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke; Patent Foramen Ovale

Treatments: Drug: Aspirin; Drug: Warfarin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00697151

6372

R01NS032525 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 630 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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630 participants in 2 patient groups

Warfarin

Active Comparator group

Description:

Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin

Treatment:

Drug: Warfarin

Aspirin

Active Comparator group

Description:

Aspirin 325 mg plus placebo warfarin

Treatment:

Drug: Aspirin