Health TrialsbyHealthPanel

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

ConditionsPatent Foramen OvaleCryptogenic StrokeOlder PatientsMedical TreatmentRecurrent Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJosep Rodes-Cabau

About this trial

Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cryptogenic stroke

Age >60 years

Right-to-left shunt as evaluated by echocardiography (TEE).

Disqualifiers

Lacunar (small vessel) stroke.

Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring).

Need for chronic anticoagulation therapy.

Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcatheter PFO closure

    Procedure/Surgery

    Transcatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study. Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

  • Optimal medical treatment

    Drug

    Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Treatment groups

714 Participants
are divided into 2 treatment groups
Group A: transcatheter PFO closure + optimal medical treatmentExperimental treatment 2 interventions
Group B: Optimal medical treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of ischemic events

New ischemic non-lacunar stroke events

Time frame
12 months

Secondary outcomes

1

Rate of stroke events

All new non-lacunar stroke events

Time frame
12 months
2

Rate of mortality

All cause mortality

Time frame
10 year follow-up
3

Rate of cardiovascular mortality

Cardiovascular death

Time frame
10 year follow-up
4

Incidence of cerebral hemorrhage

Cerebral bleeding

Time frame
10 year follow-up

Other outcomes

Sponsors and contacts

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

Josep Rodes-Cabau

Lead sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Sponsor institution

Source ClinicalTrials.gov
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