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Trial record 1 of 8 for:    CLOSE PFO stroke
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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

Tracking Information
First Submitted Date  ICMJE November 21, 2007
First Posted Date  ICMJE November 22, 2007
Last Update Posted Date October 19, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2015)
stroke(fatal or not) [ Time Frame: during the follow up (between 2 or 9 years) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
stroke(fatal or not) [ Time Frame: during the follow up (between 3 or 5 years) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
-Disabling stroke -Ischemic stroke -Cerebral haemorrhage -Ischemic stroke, TIA, or systemic embolism -Death (all causes) -Vascular death -Procedural (within 30 days) or device complications -Moderate to severe bleeding complications [ Time Frame: Procedural (within 30 days) or device complications ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
Official Title  ICMJE Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Ischemic Stroke
  • Patent Foramen Ovale
  • Atrial Septal Aneurysm
  • Migraine
Intervention  ICMJE
  • Drug: aspirin
    during the follow up
    Other Names:
    • clopidogrel
    • combination aspirin-dipyridamole
  • Drug: Antivitamins K or rivaroxaban or dabigatran or apixaban
    during the follow up
  • 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
Study Arms  ICMJE
  • Active Comparator: aspirin
    aspirin use like antiplatelet
    Intervention: Drug: aspirin
  • Experimental: anticoagulant
    Antivitamins K or rivaroxaban or dabigatran or apixaban
    Intervention: Drug: Antivitamins K or rivaroxaban or dabigatran or apixaban
  • Experimental: Devices for PFO closure
    Devices for PFO closure
    Intervention: Device: Devices for PFO closure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2016)
664
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2007)
900
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00562289
Other Study ID Numbers  ICMJE P060406
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: MAS Jean-Louis, MD, PhD Centre hospitalier sainte Anne
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP