Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS)

September 14, 2011 updated by: Columbia University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

630

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Coumadin
Active Comparator: Aspirin
Aspirin 325 mg plus placebo warfarin
Drug: Aspirin
Aspirin 325 mg once a day; placebo warfarin once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent ischemic stroke and death
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Shunichi Homma, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1993

Primary Completion (Actual)

June 1, 2000

Study Completion (Actual)

June 1, 2000

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6372
  • R01NS032525 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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