Authorised Therapeutic exploratory (Phase II) Patent foramen ovale or atrial septum defect

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

EU CTIS ID: 2024-517115-70-00

What this study is testing

The goal of the study is to evaluate hemostasis, such as coagulation activation, thrombin generation and platelet reactivity following catheter-based closure of patent foramen ovale or atrial septal defect. Differences between post-procedural regimen (i.e. DAPT and rivaroxaban) will be assessed in the current pilot study.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • - 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).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.