Anticoagulants for PFO Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

277 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2022-08-31

Brief Summary

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Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality.

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Detailed Description

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Conditions

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Patent Foramen Ovale

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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small-shunt Group

small (3-9 bubbles)

PFO closure

Intervention Type PROCEDURE

PFO closure

anticoagulant

Intervention Type DRUG

rivaroxaban

moderate-shunt Group

(10-30 bubbles)

PFO closure

Intervention Type PROCEDURE

PFO closure

anticoagulant

Intervention Type DRUG

rivaroxaban

large-shunt Group

\>30 bubbles

PFO closure

Intervention Type PROCEDURE

PFO closure

anticoagulant

Intervention Type DRUG

rivaroxaban

Interventions

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PFO closure

Intervention Type PROCEDURE

anticoagulant

rivaroxaban

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. verified PFO diagnosis through TEE, Bubble-TCD, or contrast echocardiography of the right heart;
2. ages range between 16 and 65;
3. no restrictions on sexual orientation;
4. stroke patients with cryptogenic strokes as per the TOAST classification;
5. no other likely causes for migraines, with the exception of PFO;
6. no multiple risk factors for cerebrovascular disease, such as hypertension, diabetes, or smoking.

Exclusion Criteria

* 1)severe, acute, or life-threatening conditions including acute cardio-cerebrovascular diseases, significant organ failure, or infections; 2)magnetic resonance imaging (MRI) contraindications, especially with contrast enhancement; 3) presence of cerebral artery stenosis, internal carotid artery stenosis, or atherosclerosis; 4) hypercoagulability or venous thrombosis; 5) contraindications associated with PFO closure and anticoagulants; 6) obstructive sleep apnea.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No