Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
NCT ID: NCT00562289
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
664 participants
INTERVENTIONAL
2007-12-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
aspirin
aspirin use like antiplatelet
aspirin
during the follow up
anticoagulant
Antivitamins K or rivaroxaban or dabigatran or apixaban
Antivitamins K or rivaroxaban or dabigatran or apixaban
during the follow up
Devices for PFO closure
Devices for PFO closure
Devices for PFO closure
endovascular treatment no longer than 21 days after the random.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aspirin
during the follow up
Antivitamins K or rivaroxaban or dabigatran or apixaban
during the follow up
Devices for PFO closure
endovascular treatment no longer than 21 days after the random.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
16 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MAS Jean-Louis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier sainte Anne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Saint-Anne
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G; CLOSE Investigators. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017 Sep 14;377(11):1011-1021. doi: 10.1056/NEJMoa1705915.
Turc G, Lee JY, Brochet E, Kim JS, Song JK, Mas JL; CLOSE and DEFENSE-PFO Trial Investigators. Atrial Septal Aneurysm, Shunt Size, and Recurrent Stroke Risk in Patients With Patent Foramen Ovale. J Am Coll Cardiol. 2020 May 12;75(18):2312-2320. doi: 10.1016/j.jacc.2020.02.068.
Turc G, Calvet D, Guerin P, Sroussi M, Chatellier G, Mas JL; CLOSE Investigators. Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta-Analysis, and New Insights From the CLOSE Study. J Am Heart Assoc. 2018 Jun 17;7(12):e008356. doi: 10.1161/JAHA.117.008356.
Mas JL, Derumeaux G, Amarenco P, Arquizan C, Aubry P, Barthelet M, Bertrand B, Brochet E, Cabanes L, Donal E, Dubois-Rande JL, Durand-Zaleski I, Ernande L, Finet G, Fraisse A, Giroud M, Guerin P, Habib G, Juliard JM, Leys D, Lievre M, Lusson JR, Marcon F, Michel P, Moulin T, Mounier-Vehier F, Pierard L, Piot C, Rey C, Rodier G, Roudaut R, Schleich JM, Teiger E, Turc G, Vuillier F, Weimar C, Woimant F, Chatellier G; CLOSE investigators. close: Closure of patent foramen ovale, oral anticoagulants or antiplatelet therapy to prevent stroke recurrence: Study design. Int J Stroke. 2016 Aug;11(6):724-32. doi: 10.1177/1747493016643551. Epub 2016 Apr 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P060406
Identifier Type: -
Identifier Source: org_study_id