Anticoagulants for PFO Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06375070

Enrollment

277

Registered

2024-04-19

Start date

2016-08-31

Completion date

2022-08-31

Last updated

2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Foramen Ovale

Keywords

patent foramen ovale, migraine, stroke

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.

Interventions

PROCEDUREPFO closure

PFO closure

DRUGanticoagulant

rivaroxaban

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
whether occur recurrent stroke or migraine relief	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026