Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE)
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|ClinicalTrials.gov Identifier: NCT00562289|
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : October 19, 2017
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 or disease||Intervention/treatment||Phase|
|Ischemic Stroke Patent Foramen Ovale Atrial Septal Aneurysm Migraine||Drug: aspirin Drug: Antivitamins K or rivaroxaban or dabigatran or apixaban Device: Devices for PFO closure||Phase 3|
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:
- to evaluate the safety of the three therapeutic options, in terms of major drug-, device- or procedure-related complications, in order to allow a benefit/risk assessment of each therapeutic option in this population.
- to assess the rate of technical success and effectiveness of endovascular procedure to treat PFO and ASA.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||664 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: aspirin
aspirin use like antiplatelet
during the follow up
Antivitamins K or rivaroxaban or dabigatran or apixaban
Drug: Antivitamins K or rivaroxaban or dabigatran or apixaban
during the follow up
Experimental: Devices for PFO closure
Devices for PFO closure
Device: Devices for PFO closure
endovascular treatment no longer than 21 days after the random.
- stroke(fatal or not) [ Time Frame: during the follow up (between 2 or 9 years) ]
- Disabling stroke [ Time Frame: during the follow-up ]
- Ischemic stroke [ Time Frame: during the follow-up ]
- Cerebral haemorrhage [ Time Frame: during the follow-up ]
- Ischemic stroke, TIA, or systemic embolism [ Time Frame: during the follow-up ]
- Death (all causes) [ Time Frame: during the follow-up ]
- Vascular death [ Time Frame: during the follow-up ]
- Moderate to severe bleeding complications [ Time Frame: during the follow-up ]
- Procedural or device complications [ Time Frame: within 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562289
|Principal Investigator:||MAS Jean-Louis, MD, PhD||Centre hospitalier sainte Anne|