Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

This study has been completed.

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by:

Columbia University

ClinicalTrials.gov Identifier:

NCT00697151

First received: June 11, 2008

Last updated: September 14, 2011

Last verified: September 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Ischemic Stroke Patent Foramen Ovale	Drug: Warfarin Drug: Aspirin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Patent Foramen Ovale in Cryptogenic Stroke Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Aspirin Warfarin Warfarin sodium

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Recurrent ischemic stroke and death [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	630
Study Start Date:	June 1993
Study Completion Date:	June 2000
Primary Completion Date:	June 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Warfarin Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin	Drug: Warfarin Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day Other Name: Coumadin
Active Comparator: Aspirin Aspirin 325 mg plus placebo warfarin	Drug: Aspirin Aspirin 325 mg once a day; placebo warfarin once a day Other Name: Aspirin

Eligibility

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697151

Locations

United States, New York
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Shunichi Homma, MD

Columbia University

More Information

Publications:

Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP; PFO in Cryptogenic Stroke Study (PICSS) Investigators. Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study. Circulation. 2002 Jun 4;105(22):2625-31.

Homma S, DiTullio MR, Sacco RL, Sciacca RR, Mohr JP; PICSS Investigators. Age as a determinant of adverse events in medically treated cryptogenic stroke patients with patent foramen ovale. Stroke. 2004 Sep;35(9):2145-9. Epub 2004 Jul 1.

Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP. Atrial anatomy in non-cardioembolic stroke patients: effect of medical therapy. J Am Coll Cardiol. 2003 Sep 17;42(6):1066-72.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Di Tullio MR, Russo C, Jin Z, Sacco RL, Mohr JP, Homma S; Patent Foramen Ovale in Cryptogenic Stroke Study Investigators. Aortic arch plaques and risk of recurrent stroke and death. Circulation. 2009 May 5;119(17):2376-82. Epub 2009 Apr 20.

Responsible Party:	Shunichi Homma,MD - Principal Investigator, Columbia University
ClinicalTrials.gov Identifier:	NCT00697151 History of Changes
Other Study ID Numbers:	6372, R01NS032525
Study First Received:	June 11, 2008
Last Updated:	September 14, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

cerebrovascular diseases
ischemic stroke
patent foramen ovale

warfarin
aspirin
transesophageal echocardiography

Additional relevant MeSH terms:

Foramen Ovale, Patent
Heart Septal Defects, Atrial
Ischemia
Stroke
Cerebral Infarction
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

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