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

ConditionsCryptogenic Ischemic StrokePatent Foramen Ovale
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60-80
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Man or woman aged 60 to 80 years.

Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration.

Absence of a more probable cause of stroke than PFO after a standardized etiological work-up (see addenda).

PFO with large shunt (> 20 microbubbles) appearing in the left atrium during at least one of the 3 cardiac cycles after complete opacification of the right atrium, detected either spontaneously or during provocative manoeuvers, on contrast transthoracic (TTE) or transoesophageal (TOE) echocardiography. The diagnosis of PFO by contrast TEE must be confirmed by contrast TOE showing a right-to-left passage of the contrast material across the PFO.

Disqualifiers

Life expectancy < 4 years.

Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 20.5).

Indication to long-term anticoagulant therapy.

mRS > 3.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcatheter PFO closure

    Procedure/Surgery

    PFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel until the end of the study.

  • Oral Anticoagulant, Direct-Acting

    Drug

    Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)

  • Antiplatelet therapy

    Drug

    Patients randomized to this arm will receive antiplatelet therapy throughout the study : aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then single antiplatelet therapy by aspirin or clopidogrel

Treatment groups

792 Participants
are divided into 3 treatment groups
Group A: Antiplatelet therapyActive comparator 1 intervention
Group B: Oral anticoagulants, Direct-ActingExperimental treatment 1 intervention
Group C: PFO closureExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Time to recurrent stroke (ischemic or hemorrhagic fatal or non-fatal)

Stroke: sudden onset of focal neurological symptoms related to a disturbance of the cerebral circulation. Ischemic stroke : at least one of the following criteria: * Sudden onset of focal neurological symptoms with the presence of cerebral infarction in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours). * Sudden onset of focal neurological symptoms lasting more than 24 hours, with no apparent cause other than cerebral ischemia. Intracerebral hemorrhage: sudden onset of focal neurological symptoms with the presence of cerebral hemorrhage in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours) and regardless of the cause of the hemorrhage (spontaneous or secondary to trauma, tumour or another cause). Unknown type of stroke : the type of stroke cannot be determined with certainty and the symptoms last more than 24 hours.

Time frame
From date of randomization until the date of first recurrent stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Secondary outcomes

1

Time to disabling stroke

mRS score greater than or equal to 3, with an increase of at least 2 points compared to the last mRS score before the stroke.

Time frame
From date of randomization until the date of first recurrent disabling stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)
2

Time to ischemic stroke

At least one of the following criteria: * Sudden onset of focal neurological symptoms with the presence of cerebral infarction in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours). * Sudden onset of focal neurological symptoms lasting more than 24 hours, with no apparent cause other than cerebral ischemia.

Time frame
From date of randomization until the date of first recurrent ischemic stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)
3

Time to ischemic stroke or systemic embolism

Clinical features related to embolism usually affecting a limb, mesenteric, splenic, or renal artery. The diagnosis of embolism must be confirmed by appropriate investigations.

Time frame
From date of randomization until the date of first recurrent ischemic stroke or systemic embolism, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)
4

Time to transient ischemic attack,

Sudden onset of neurological symptoms, presumed to be ischemic, resolving in less than 24 hours, clearly attributable to focal involvement of the central nervous system (or of the eye) with no signs of a corresponding recent cerebral infarction on brain imaging. The diagnosis of TIA will be confirmed by a neurologist, considering clinical data and brain imaging (MRI with diffusion sequence is recommended).

Time frame
From date of randomization until the date of first transient ischemic attack, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator

W.L.Gore & Associates

Collaborator

Abbott

Collaborator

Occlutech International AB

Collaborator

Centre Hospitalier St Anne

Collaborator

Source ClinicalTrials.gov
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