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.
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.
- Anticoagulants Drug
- PFO Closure + chronic antiplatelet therapy Procedure/Surgery
Intervention Desc: For the non-surgical closure of a patent foramen ovale (PFO) in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovale. Chronic antiplatelet therapy (ASA or clopidogrel or association of ASA & dipyridamole).
- Chronic Antiplatelet Treatment Drug
Intervention Desc: ASA or clopidogrel or association of ASA & dipyridamole
- Aspirin Drug
Other Names: clopidogrel; combination aspirin-dipyridamole Intervention Desc: during the follow up ARM 1: Kind: Experimental Label: 1 ARM 2: Kind: Experimental Label: aspirin Description: aspirin use like antiplatelet
- Antivitamins K Drug
Other Names: Antivitamins K Intervention Desc: during the follow up ARM 1: Kind: Experimental Label: 2 ARM 2: Kind: Experimental Label: anticoagulant Description: Antivitamins K or rivaroxaban or dabigatran
- Devices for PFO closure Device
Other Names: Each device for PFO closure must have the CE mark; and be approved by the Interventional Cardiology Committee Intervention Desc: endovascular treatment no longer than 21 days after the random. ARM 1: Kind: Experimental Label: 3 ARM 2: Kind: Experimental Label: Devices for PFO closure Description: Devices for PFO closure
- Antivitamins K or rivaroxaban or dabigatran or apixaban Drug
Intervention Desc: during the follow up ARM 1: Kind: Experimental Label: anticoagulant Description: Antivitamins K or rivaroxaban or dabigatran or apixaban
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomized to either drug therapy or PFO closure +chronic antiplatelet therapy arm as treatment for PFO. Target INR range 2-3 for chronic oral anticoagulation arm.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Stroke (fatal or not) during the follow up of 3 or 5 years.|
|Secondary||Disabling stroke; ischemic stroke; cerebral haemorrhage; ischemic stroke, TIA, or systemic embolism; mortality; vascular death; moderate to severe bleeding complications during the follow-up. Procedural or device complications within 30 days.|
|Primary||stroke(fatal or not)||during the follow up (between 3 or 5 years)||Yes|
|Secondary||Disabling stroke||during the follow-up||Yes|
|Secondary||Ischemic stroke||during the follow-up||Yes|
|Secondary||Cerebral haemorrhage||during the follow-up||Yes|
|Secondary||Ischemic stroke, TIA, or systemic embolism||during the follow-up||Yes|
|Secondary||Death (all causes)||during the follow-up||Yes|
|Secondary||Vascular death||during the follow-up||Yes|
|Secondary||Moderate to severe bleeding complications||during the follow-up||Yes|
|Secondary||Procedural or device complications||within 30 days||Yes|