Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · May 11, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to prevent blood clots in patients who have recently undergone a procedure called Transcatheter Aortic Valve Replacement (TAVR). It compares two types of blood-thinning treatments: one group will take a medication called oral anticoagulation (like warfarin), while the other group will take aspirin. Both groups will be monitored for six months to see how well their treatment works in preventing complications, particularly focusing on the health of the newly implanted heart valve. After six months, everyone will switch to taking aspirin alone and will be followed for a year to gather more information.

To participate in this study, individuals should be between 18 and 85 years old, have severe aortic stenosis, and must have successfully received a TAVR using a specific method. However, certain patients may not be eligible, such as those with specific blood clotting issues or recent heart emergencies. Participants can expect to be part of a study that aims to improve care for future patients by comparing the effectiveness of these two treatments while being closely monitored by medical professionals throughout the year.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18-85 years old with severe aortic stenosis;
• • Successful TAVR via femoral artery approach (VARC 3 device success criteria);
• • Implantation of self-expanding bioprosthetic valve;
• • Be willing to give informed consent.
• Exclusion Criteria:
• • Patients with anticoagulant indications, such as atrial fibrillation, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism, history of mechanical valve implantation;
• • Patients needed double antiplatelet therapy, such as acute myocardial infarction within one year, coronary stent implantation within 6 months, peripheral artery stent implantation within 3 months;
• • Patients who received concomitant TAVR and percutaneous coronary intervention;
• • Patients with peptic ulcers or active bleeding or history of cerebral hemorrhage
• • Patients with ischemic stroke or TIA within 6 months;
• • Patients with left ventricular ejection fraction \< 30% or pulmonary hypertension (\>70mmHg) before discharge;
• • Patients intolerant or allergic to aspirin or Vitamin-K antagonists (warfarin);
• • Patients with evaluated glomerular filtration rate \<15ml/min/m2 (Cockcroft formula) or on dialysis;
• • Patients with poor compliance, unable to complete the study and follow-up as required;
• • Patients' life expectancy less than 1 year;
• • Patients who already participated in other clinical trials (within the last 30 days).