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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00562289 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Stroke Patent Foramen Ovale Atrial Septal Aneurysm Migraine |
Drug: aspirin Drug: Antivitamins K Device: Devices for PFO closure |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence |
| Estimated Enrollment: | 900 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: aspirin
during the follow up
|
| 2: Experimental |
Drug: Antivitamins K
during the follow up
|
| 3: Experimental |
Device: Devices for PFO closure
endovascular treatment no longer than 21 days after the random.
|
Secondary prevention for stroke patients with PFO is a subject of considerable debate. Therapeutic options include antiplatelet drugs, oral anticoagulants, and transcatheter closure of the foramen. There are no published studies showing convincingly the superiority of any one of these strategies in preventing stroke recurrence. All the therapeutic options have some risks and unless randomised trials can define who should be treated with what (if anything), and for how long, we could end up exposing patients to unnecessary complications of treatment.
The primary objective of this study is to assess whether chronic anticoagulation (INR 2 to 3) on the one hand and endovascular treatment on the other hand are superior to chronic antiplatelet therapy in preventing stroke recurrence in young (16 to 60 years) patients with a PFO (> 30 microbubbles or associated with an atrial septal aneurysm) and an otherwise unexplained ischaemic stroke.
Secondary objectives of the study are:
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of a PFO with at least one of the following characteristics:
Exclusion Criteria:
Related medical treatments of the trial:
Contra-indication to antiplatelet therapy or oral anticoagulants :
Related to endovascular treatments :
Contacts and Locations| France | |
| Hopital Saint Anne | Recruiting |
| PARIS, France, 75014 | |
| Contact: Jean Louis MAS, MD PHD +33(0)-145658284 jl.mas@ch-sainte anne.fr | |
| Principal Investigator: | MAS Jean-Louis, MD, PhD | Centre hospitalier sainte Anne |
More Information
| Responsible Party: | Departement clinical research of the developement ( Mathieu QUINTIN ) |
| Study ID Numbers: | P060406 |
| Study First Received: | November 21, 2007 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00562289 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Stroke Patent Foramen Ovale Atrial septal aneurysm Antiplatelet therapy |
Oral anticoagulants Transcatheter closure Migraine |
|
Anti-Inflammatory Agents Coagulants Cerebral Infarction Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Brain Diseases Headache Disorders Fibrin Modulating Agents Pathologic Processes Migraine Disorders Therapeutic Uses Cardiovascular Diseases Heart Diseases Anticoagulants |
Cardiovascular Abnormalities Nervous System Diseases Cyclooxygenase Inhibitors 4-Hydroxycoumarins Hemostatics Vitamin K Platelet Aggregation Inhibitors Disease Attributes Headache Disorders, Primary Fibrinolytic Agents Cerebrovascular Disorders Heart Septal Defects, Atrial Antivitamins K Aspirin Foramen Ovale, Patent |