Patent Foramen Ovale in Cryptogenic Stroke Study

Columbia University630 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

630

Conditions

Ischemic Stroke Patent Foramen Ovale

Interventions

WarfarinDRUG

Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day

AspirinDRUG

Aspirin 325 mg once a day; placebo warfarin once a day

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Columbia College of Physicians and Surgeons

New York, New York, United States

Outcomes

Primary Outcomes

Recurrent ischemic stroke and death

Time frame: 2 years

Data from ClinicalTrials.gov

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