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

NCT05375474 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: CSC-20220504
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Replacement; Antithrombotic Therapy; Bioprosthetic Valve Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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)

  1 year

• Cardiac death

  1 year

• Minor bleeding (BRAC 2)

  1 year

• Bleeding (BRAC 1, 2, 3a-c, 5)

  1 year

Study Arms (2)

Oral anticoagulation therapy group

EXPERIMENTAL

Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5

Drug: Oral anticoagulation therapy

Single antiplatelet therapy group

ACTIVE COMPARATOR

Aspirin, 75-100mg

Drug: Single antiplatelet therapy

Interventions

Oral anticoagulation therapy DRUG

Vitamin-K antagonists (warfarin)

Oral anticoagulation therapy group

Single antiplatelet therapy DRUG

Aspirin

Single antiplatelet therapy group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (1)

• Hu X, Xu H, Wang C, Wang Y, Wang Y, Zhou D, Zhu Q, Xu K, Yang J, Zhang H, Jiang N, Zhang J, Fang Z, Fu G, Guo Y, Li Y, Wang M, Feng D, Niu G, Zhang E, Chen Y, Ye Y, Wu Y. Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial. BMJ Open. 2023 Nov 21;13(11):e076781. doi: 10.1136/bmjopen-2023-076781.

  PMID: 37989381 DERIVED

Study Officials

• Yongjian Wu, MD,PhD

  Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

  STUDY CHAIR

• Yunqing Ye, Master

  Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Yongjian Wu, MD,PhD

CONTACT

+86 13701387189; yongjianwu_nccd@163.com

Yunqing Ye, Master

CONTACT

+86 13699282532; judia8510@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of coronary artery disease center

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: July 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)