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

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement; Antithrombotic Therapy; Bioprosthetic Valve Thrombosis
• Intervention / Treatment: Drug: Oral anticoagulation therapy; Drug: Single antiplatelet therapy

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yongjian Wu, MD,PhD; Phone Number: +86 13701387189; Email: yongjianwu_nccd@163.com
• Study Contact Backup: Name: Yunqing Ye, Master; Phone Number: +86 13699282532; Email: judia8510@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital
      • Contact: Yongjian Wu, MD, PhD; Phone Number: +86 13701387189; Email: yongjianwu_nccd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral anticoagulation therapy group; Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5	Drug: Oral anticoagulation therapy; Vitamin-K antagonists (warfarin)
Active Comparator: Single antiplatelet therapy group; Aspirin, 75-100mg	Drug: Single antiplatelet therapy; Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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
Rates of bioprosthetic valve thrombosis detected by 4D-CT		1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Study Chair: Yongjian Wu, MD,PhD, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences; Study Director: Yunqing Ye, Master, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: CSC-20220504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes