Clinical trial NCT05375474: Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
Official title: Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Transcatheter Aortic Valve Replacement
Antithrombotic Therapy
Bioprosthetic Valve Thrombosis
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-05-16
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.


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).

Primary outcomes:
measure: A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis, major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
timeFrame: 1 year
measure: Rates of bioprosthetic valve thrombosis detected by 4D-CT
timeFrame: 1 year
Secondary outcomes:
measure: A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis
timeFrame: 1 year
measure: Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
timeFrame: 1 year
measure: Cardiac death
timeFrame: 1 year
measure: Minor bleeding (BRAC 2)
timeFrame: 1 year
measure: Bleeding (BRAC 1, 2, 3a-c, 5)
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: TIA
timeFrame: 1 year
measure: Peripheral artery thrombosis
timeFrame: 1 year
measure: Intracardiac thrombosis
timeFrame: 1 year
measure: Major bleeding (BARC 3a)
timeFrame: 1 year
measure: Disabling/life-threatening bleeding (BARC 3b,3c,5)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
name: Yongjian Wu, MD,PhD
role: STUDY_CHAIR
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
name: Yunqing Ye, Master
role: STUDY_DIRECTOR
References: