Overview

This trial is active, not recruiting.

Conditions ischemic stroke, patent foramen ovale, atrial septal aneurysm, migraine
Treatments aspirin, antivitamins k or rivaroxaban or dabigatran or apixaban, devices for pfo closure
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Start date December 2007
End date December 2016
Trial size 664 participants
Trial identifier NCT00562289, P060406

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
aspirin use like antiplatelet
aspirin clopidogrel
during the follow up
(Experimental)
Antivitamins K or rivaroxaban or dabigatran or apixaban
antivitamins k or rivaroxaban or dabigatran or apixaban
during the follow up
(Experimental)
Devices for PFO closure
devices for pfo closure Each device for PFO closure must have the CE mark
endovascular treatment no longer than 21 days after the random.

Primary Outcomes

Measure
stroke(fatal or not)
time frame: during the follow up (between 2 or 9 years)

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 16 years up to 60 years old.

Inclusion Criteria: - Male or female, 16 <= age <= 60 ans. - Recent (<= 6 months) ischemic stroke documented by CT-san or MRI (whatever the duration of symptoms: shorter or longer than 24 hours). - Modified Rankin score <=3. - Absence of any other identifiable cause of stroke - Presence of a PFO with at least one of the following characteristics: - right-to-left shunt > 30 microbubbles, at rest or during provocative manoeuvres, by TTE ou TOE - associated ASA (base ≥ à 15 mm, total excursion > à 10 mm) by TOE - Informed consent. Exclusion Criteria: - Any identifiable cause of ischemic stroke other than PFO. - Isolated atrial septal defect or atrial septal defect associated with PFO with significant left-to-right shunt requiring closure. - Previous surgical or endovascular treatments of PFO or ASA. - Known or suspected pregnancy (beta hCG test must be performed before inclusion). - Women who are breast-feeding. - Inability to comply with the treatments or follow-up requirements of the study. - No affiliation to the national health service. - Presence of other medical problems that would either lead to inability to complete the trial or interfere with the assessment of outcomes. - Participation in another study. - Unable to understand the full meaning of the informed consent. - Related medical treatments of the trial: - Long-term oral anticoagulation or antiplatelet therapy is indicated for another disease. - Contra-indication to antiplatelet therapy or oral anticoagulants : - 3-arm trial : contra-indication to aspirin or clopidogrel or antivitamins K - 2-arm trial (closure vs antiplatelet therapy) : contra-indication to aspirin or clopidogrel - 2-arm trial (antivitamins K vs antiplatelet therapy : contra-indication to antivitamins K or to any antiplatelet drug - Increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding (e.g. gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, or intracranial hemorrhage), or other history of bleeding diathesis or coagulopathy. - Related to endovascular treatments : - Infection requiring antibiotics (inclusion is possible after healing, 4 weeks after withdrawal of antibiotics). - Very large or multi-perforated ASA for which endovascular treatments is deemed too risky. - Presence of thrombus or occlusion between the venous access and the right atrium. - Presence of an inferior vena cava filter. - Severe pulmonary hypertension.

Additional Information

Official title Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
Principal investigator MAS Jean-Louis, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.