In short
Currently, there is 1 ongoing clinical trial investigating treatments for patients with atrial septal defect who are undergoing closure procedures. This trial, conducted in the Netherlands, focuses on comparing different blood-thinning medications to improve outcomes after heart procedures.
Clinical trial locations
Study on Blood Thinners Rivaroxaban, Clopidogrel, and Aspirin for Patients with Heart Defects Undergoing Closure Procedures
This trial is investigating the best approach to prevent blood clots after a procedure to close a small opening in the heart, such as a patent foramen ovale or atrial septal defect. These conditions involve a hole between the upper chambers of the heart that can lead to complications if left untreated.
Who can participate:
- Adults aged 18 years or older
- Patients scheduled to undergo a catheter-based procedure to close a patent foramen ovale or atrial septal defect
- Individuals who are able to understand the study information and provide written consent
Who cannot participate:
Patients who have certain types of heart openings that are not suitable for this study, specifically those with particular characteristics of patent foramen ovale or atrial septal defect, will be excluded from participation.
What the trial involves:
After the heart closure procedure, participants will be assigned to receive one of several medication options. These include Xarelto (rivaroxaban), taken as a 20 mg tablet once daily, or Plavix (clopidogrel) 75 mg tablet once daily combined with acetylsalicylic acid (aspirin). Some participants may receive a placebo for comparison purposes.
The study aims to understand how these different medications affect blood clotting and platelet activity, which are important factors in preventing complications after the procedure. Throughout the trial, participants will undergo regular blood tests to measure various clotting factors and assess how well the treatment is working.
Investigational drugs:
The trial is testing rivaroxaban, a blood thinner that works by blocking proteins involved in blood clot formation. This medication is being compared with dual antiplatelet therapy (DAPT), which uses two medications together to prevent platelets from sticking together and forming clots. The goal is to determine which approach provides the best protection against blood clots while minimizing potential risks.
The study is expected to conclude by January 2026 and will provide valuable information to help doctors choose the most effective treatment for patients undergoing these heart procedures.
Summary
This single ongoing clinical trial for atrial septal defect is being conducted in the Netherlands and focuses specifically on post-procedure care following heart defect closure. The trial represents an important effort to optimize blood-thinning therapy for these patients, comparing established medications like rivaroxaban and clopidogrel with aspirin. The study's findings may help refine treatment guidelines for patients undergoing catheter-based closure procedures for heart defects, potentially improving safety and outcomes in this patient population.
