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Patent Foramen Ovale in Cryptogenic Stroke Study

NCT00697151 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 630

Last updated 2011-09-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Warfarin

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

DRUG

Aspirin

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Shunichi Homma, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-06-30
Primary Completion
2000-06-30
Completion
2000-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697151 on ClinicalTrials.gov