Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00562289

Purpose

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	Intervention	Phase
Ischemic Stroke Patent Foramen Ovale Atrial Septal Aneurysm Migraine	Drug: aspirin Drug: Antivitamins K Device: Devices for PFO closure	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Aneurysms Blood Thinners Migraine

Drug Information available for: Acetylsalicylic acid Dipyridamole Clopidogrel

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

stroke(fatal or not) [ Time Frame: during the follow up (between 3 or 5 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disabling stroke [ Time Frame: during the follow-up ] [ Designated as safety issue: Yes ]
Ischemic stroke [ Time Frame: during the follow-up ] [ Designated as safety issue: Yes ]
Cerebral haemorrhage [ Time Frame: during the follow-up ] [ Designated as safety issue: Yes ]
Ischemic stroke, TIA, or systemic embolism [ Time Frame: during the follow-up ] [ Designated as safety issue: Yes ]
Death (all causes) [ Time Frame: during the follow-up ] [ Designated as safety issue: Yes ]
Vascular death [ Time Frame: during the follow-up ] [ Designated as safety issue: Yes ]
Moderate to severe bleeding complications [ Time Frame: during the follow-up ] [ Designated as safety issue: Yes ]
Procedural or device complications [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	900
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: aspirin during the follow up Other Names: aspirin clopidogrel combination aspirin-dipyridamole
Experimental: 2	Drug: Antivitamins K during the follow up Other Name: Antivitamins K
Experimental: 3	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

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.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562289

Locations

France
Hopital Saint Anne	Recruiting
Paris, France, 75014
Contact: Jean Louis MAS, MD PHD +33(0)-145658284 jl.mas@ch-sainte anne.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

MAS Jean-Louis, MD, PhD

Centre hospitalier sainte Anne

More Information

No publications provided

Responsible Party:	Mathieu QUINTIN, Departement clinical research of the developement
ClinicalTrials.gov Identifier:	NCT00562289 History of Changes
Other Study ID Numbers:	P060406
Study First Received:	November 21, 2007
Last Updated:	January 16, 2008
Health Authority:	France: Ministry of Health

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:

Aneurysm
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Recurrence
Stroke
Cerebral Infarction
Migraine Disorders
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Disease Attributes

Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Headache Disorders, Primary
Headache Disorders
Aspirin
Aspirin, dipyridamole drug combination
Dipyridamole
4-Hydroxycoumarins
Vitamin K
Antivitamins K

ClinicalTrials.gov processed this record on February 09, 2012