Status:
UNKNOWN
Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Transcatheter Aortic Valve Replacement
Antithrombotic Therapy
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAV...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT05375474
Start Date
July 27 2023
End Date
December 31 2025
Last Update
October 23 2023
Active Locations (1)
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1
Fuwai hospital
Beijing, Beijing Municipality, China, 100037