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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00562289
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief 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.


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

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Blood Thinners
Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: aspirin
aspirin use like antiplatelet
 Drug: aspirin
during the follow up
Other Names:
  • clopidogrel
  • combination aspirin-dipyridamole
Experimental: anticoagulant
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.
Other Names:
  • Each device for PFO closure must have the CE mark
  • and be approved by the Interventional Cardiology Committee


Outcome Measures
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Primary Outcome Measures :
  1. stroke(fatal or not) [ Time Frame: during the follow up (between 2 or 9 years) ]

Secondary Outcome Measures :
  1. Disabling stroke [ Time Frame: during the follow-up ]
  2. Ischemic stroke [ Time Frame: during the follow-up ]
  3. Cerebral haemorrhage [ Time Frame: during the follow-up ]
  4. Ischemic stroke, TIA, or systemic embolism [ Time Frame: during the follow-up ]
  5. Death (all causes) [ Time Frame: during the follow-up ]
  6. Vascular death [ Time Frame: during the follow-up ]
  7. Moderate to severe bleeding complications [ Time Frame: during the follow-up ]
  8. Procedural or device complications [ Time Frame: within 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Hôpital Saint-Anne
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: MAS Jean-Louis, MD, PhD Centre hospitalier sainte Anne
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00562289    
Other Study ID Numbers: P060406
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: January 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Stroke
Patent Foramen Ovale
Atrial septal aneurysm
Antiplatelet therapy
 Oral anticoagulants
Transcatheter closure
Migraine
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Aneurysm
Foramen Ovale, Patent
Recurrence
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Heart Septal Defects, Atrial
Heart Septal Defects
 Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Aspirin
Dipyridamole
Rivaroxaban
Apixaban
Dabigatran
Antivitamins K
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents