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

Phase 4

Recruiting

• Conditions: Transcatheter Aortic Valve Replacement; Antithrombotic Therapy; Bioprosthetic Valve Thrombosis
• Interventions: Drug: Single antiplatelet therapy; Drug: Oral anticoagulation therapy

• Registration Number: NCT05375474
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-16
• Study Start: 2023-07-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single antiplatelet therapy group	Single antiplatelet therapy	Aspirin, 75-100mg
Oral anticoagulation therapy group	Oral anticoagulation therapy	Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5

Primary Outcome Measures

Name	Time	Method
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)	1 year	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)
Rates of bioprosthetic valve thrombosis detected by 4D-CT	1 year

Secondary Outcome Measures

Name	Time	Method
Bleeding (BRAC 1, 2, 3a-c, 5)	1 year	Bleeding (BRAC 1, 2, 3a-c, 5)
All-cause mortality	1 year	All-cause mortality
Peripheral artery thrombosis	1 year	Peripheral artery thrombosis
A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis	1 year	A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis
Myocardial infarction	1 year	Myocardial infarction
Stroke	1 year	Stroke
Major bleeding (BARC 3a)	1 year	Major bleeding (BARC 3a)
Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)	1 year	Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)
Cardiac death	1 year	Cardiac death
Minor bleeding (BRAC 2)	1 year	Minor bleeding (BRAC 2)
Disabling/life-threatening bleeding (BARC 3b,3c,5)	1 year	Disabling/life-threatening bleeding (BARC 3b,3c,5)
TIA	1 year	TIA
Intracardiac thrombosis	1 year	Intracardiac thrombosis

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China