Anticoagulants for PFO Patients

Patent Foramen Ovale Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06375070
• Other study ID #: RMeng1
• Status: Completed
• Start date: August 2016
• Est. completion date: August 2022

Study information

• Verified date: April 2024
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale

Intervention

Procedure:
• PFO closure
PFO closure

Drug:
• anticoagulant
rivaroxaban

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whether occur recurrent stroke or migraine relief		12 months