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Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence

NCT00562289 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2017-10-19

No results posted yet for this study

Summary

A patent foramen ovale (PFO) is found more frequently in patients with an ischemic stroke than in control subjects.

Therapeutic options to prevent stroke recurrence include antiplatelet drugs, oral anticoagulants, and transcatheter closure of the foramen. However, there are no published studies showing convincingly the superiority of any one of these strategies in preventing stroke recurrence.

The aim of this randomized clinical trial is to assess whether chronic anticoagulation on the one hand and transcatheter on the other hand are superior to chronic antiplatelet therapy in preventing stroke recurrence.

Conditions

Interventions

DRUG

aspirin

during the follow up

DRUG

Antivitamins K or rivaroxaban or dabigatran or apixaban

during the follow up

DEVICE

Devices for PFO closure

endovascular treatment no longer than 21 days after the random.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • MAS Jean-Louis, MD, PhD · Centre hospitalier sainte Anne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT00562289 on ClinicalTrials.gov