Ended Therapeutic confirmatory (Phase III) Aortic stenosis

Blood thinners after transcatheter implantation of a new heart valve in patients with aortic stenosis

EU CTIS ID: 2023-510211-20-00

What this study is testing

To conduct a pragmatic randomized controlled trial assessing the optimal antithrombotic strategy in patients undergoing transcathter aortic valve implantation for aortic stenosis.

  • Therapeutic confirmatory (Phase III)

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

  • Age 65-80 years old
  • Successful TAVI for aortic stenosis
  • Signed informed consent form
  • Expected compliance with protocol

You likely can't join if

  • Contraindications for any of the treatment arms
  • Strict indication for antiplatelet drugs (i.e. percutaneous coronary intervention last 12 months, or other)
  • Strict indication for oral anticoagulants (i.e. atrial fibrillation with high stroke risk, recent or recurrent venous thromboembolism, or other)
  • Unable to start study medication within 72 hours after the procedure
  • Drug interactions - Concomitant use of inhibitors of CYP3A4 and P-glycoprotein (such as the antimycotic agents ketoconazole, itraconazole, voriconazole, posaconazole and HIV-protease inhibitors) and inducers of CYP3A4 and P-glycoprotein (phenytoin, carbamazepine, phenobarbital or St. Johns wort).

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, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

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.