Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect

Phase 1

• Conditions: Patent foramen ovale or atrial septum defect; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-517115-70-00
• Lead Sponsor: Sint Antonius Ziekenhuis Stichting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

The subject is aged 18 years or older - The subject is scheduled for percutaneous closure of a PFO or ASD as indicated by the treating physician - The subject is able to understand and is willing to provide written informed consent to participate in the trial

Exclusion Criteria

- Unable or unwilling to return for required follow-up visits - High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical - Mechanical heart valves or valvular disease requiring surgery or interventional procedure - Ongoing major bleeding or complicated or recent (<72 hours) major surgery - Severe thrombocytopenia (<50.000/ml) - Mitral valve regurgitation grade 3 or more - Aortic valve stenosis (AVA<1.0cm2 or Pmax>50 mmHg) or regurgitation grade 3 or more - Left ventricular ejection fraction <30% - Life expectancy of less than 1 year - Any indication for long-term oral anticoagulation other than presence/closure of a PFO/ASD (such as atrial fibrillation) - Any indication for long-term (dual) antiplatelet therapy other than presence/closure of a PFO/ASD (such as recent coronary stenting) - Contraindication for the use of rivaroxaban or DAPT (e.g. history of intracranial bleeding) in the investigator's opinion - Pregnant or planning to become pregnant during the time of the study - Estimated glomerular filtration rate <50 ml/min/1.73m2 - Use of medication that significantly interacts with rivaroxaban; medication that inhibits cytochrome P450 3A4 or P-glycoprotein (such as ketoconazole, human immunodeficiency virus (HIV) protease inhibitors, clarithromycin, erythromycin and fluconazole) or induces cytochrome P450 3A4 (such as rifampicin and several anti-epileptic drugs).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified