Patent Foramen Ovale in Cryptogenic Stroke Study

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Nervous System Diseases Patent Foramen Ovale Stroke Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia College of Physicians and Surgeons

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

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

Other names: Coumadin

Aspirin

Drug

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

Primary outcomes

Recurrent ischemic stroke and death

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Acronym: PICSS

Important dates

Study start: 1993
Primary completion: 2000
Study completion: 2000
First posted: Jun 13, 2008
Registry last updated: Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed