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Completed

NCT Number: NCT06375070

Anticoagulants for PFO Patients

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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Key information

Conditions

Patent Foramen Ovale Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Headache Disorders Headache Disorders, Primary Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Migraine Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

PFO closure

Procedure

PFO closure

Anticoagulant

Drug

rivaroxaban

Primary outcomes

  1. whether occur recurrent stroke or migraine relief

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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