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

NCT ID: NCT05375474

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-27
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral anticoagulation therapy group

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

Group Type: EXPERIMENTAL

Oral anticoagulation therapy

Intervention Type: DRUG

Vitamin-K antagonists (warfarin)

Single antiplatelet therapy group

Aspirin, 75-100mg

Group Type: ACTIVE_COMPARATOR

Single antiplatelet therapy

Intervention Type: DRUG

Aspirin

Interventions

Oral anticoagulation therapy

Vitamin-K antagonists (warfarin)

Intervention Type: DRUG

Single antiplatelet therapy

Aspirin

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yongjian Wu, MD, PhD

Director of coronary artery disease center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongjian Wu, MD,PhD

Role: STUDY_CHAIR

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

Yunqing Ye, Master

Role: STUDY_DIRECTOR

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

Locations

Fuwai hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongjian Wu, MD,PhD

Role: CONTACT

yongjianwu_nccd@163.com

+86 13701387189

Yunqing Ye, Master

Role: CONTACT

judia8510@163.com

+86 13699282532

Facility Contacts

Yongjian Wu, MD, PhD

Role: primary

yongjianwu_nccd@163.com

+86 13701387189

References

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.

Reference Type: DERIVED

PMID: 37989381 (View on PubMed)

Other Identifiers

CSC-20220504

Identifier Type: -

Identifier Source: org_study_id