PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After

Status Not yet recruiting

Clinical Trial Summary

To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

Clinical Trial Description

The CLOSE trial (NCT00562289, NEJM 2017) has unambiguously demonstrated the superiority of patent foramen ovale (PFO) closure over antiplatelet therapy alone in patients aged up to 60 years with a PFO associated with an atrial septal aneurysm (ASA) or a large right-to-left shunt (so-called "high-risk PFO"), and an otherwise unexplained ischemic stroke. Oral anticoagulant therapy is also a logical approach assuming that PFO-related strokes are due to paradoxical embolism which implies a venous source of embolism, or to direct embolization of a thrombus formed at the atrial level. The CLOSE trial also suggested that oral anticoagulants might reduce stroke recurrence compared to aspirin. There is accumulating evidence that presence of a PFO is significantly associated with cryptogenic stroke in patients over 60 years. Cryptogenic ischemic strokes represent about one third of all ischemic strokes in patients older than 60 years. However, the optimal therapeutic strategy in patients older than 60 years with a PFO and an otherwise unexplained ischemic stroke is unknown, because these patients were excluded from randomized trials. The hypothesis tested in this trial is that transcatheter PFO closure plus long-term antiplatelet therapy is superior to antiplatelet therapy alone and that oral anticoagulant therapy is superior to antiplatelet therapy to prevent recurrent stroke in patients aged 60 to 80 years who have a high-risk PFO and a recent otherwise unexplained ischemic stroke. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05387954
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	Aurélie Guimfack
Phone	+331 44 84 17 98
Email	aurelie.guimfack@aphp.fr
Status	Not yet recruiting
Phase	Phase 3
Start date	June 1, 2022
Completion date	June 1, 2030

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See also
Status	Clinical Trial	Phase
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Completed	`NCT04604015` - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt	N/A
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
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Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Terminated	`NCT01018355` - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI	N/A
Completed	`NCT00831259` - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)	N/A
Not yet recruiting	`NCT05360771` - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System	N/A
Recruiting	`NCT05546320` - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale	Phase 4
Recruiting	`NCT05561660` - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)	Phase 4
Completed	`NCT03904277` - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting	`NCT06120270` - CeraFlex PFO Closure System PMCF Study
Terminated	`NCT01773252` - Right to Left Cardiac Shunt Detection	Phase 3
Completed	`NCT01216423` - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale	N/A
Completed	`NCT03377465` - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis	N/A
Active, not recruiting	`NCT04738071` - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting	`NCT06413147` - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting	`NCT06344494` - Cardiac Interventional ICE Imaging Trial	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years — CLOSE-2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms