Anticoagulants for PFO Patients

NCT06375070 | Completed DMC

• 1 other identifier: RMeng1
• Study Type: observational
• Target: 277
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patent Foramen Ovale

Keywords

patent foramen ovale; migraine; stroke

Outcome Measures

Primary Outcomes (1)

• whether occur recurrent stroke or migraine relief

  12 months

Study Arms (3)

small-shunt Group

small (3-9 bubbles)

Procedure: PFO closure; Drug: anticoagulant

moderate-shunt Group

(10-30 bubbles)

Procedure: PFO closure; Drug: anticoagulant

large-shunt Group

\>30 bubbles

Procedure: PFO closure; Drug: anticoagulant

Interventions

PFO closure PROCEDURE

PFO closure

large-shunt Group; moderate-shunt Group; small-shunt Group

anticoagulant DRUG

rivaroxaban

large-shunt Group; moderate-shunt Group; small-shunt Group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible participants had their PFO diagnosis confirmed via transoesophageal echocardiography (TEE), bubble transcranial Doppler (Bubble-TCD), or contrast echocardiography of the right heart and gave their informed consent to participate

You may qualify if:

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

You may not qualify if:

• )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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

Foramen Ovale, Patent; Migraine Disorders; Stroke

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: August 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share