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

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05375474
Collaborator
(none)
420
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus double antiplatelet therapy (DAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the DAPT group (aspirin and clopidogrel) 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 prosthetic valve thrombosis diagnosed by 4D-CT.

Condition or Disease Intervention/Treatment Phase
  • Drug: oral anticoagulation therapy
  • Drug: double antiplatelet therapy
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: oral anticoagulation therapy group

Drug: oral anticoagulation therapy
Vitamin-K antagonists
Active Comparator: double antiplatelet therapy group

Drug: double antiplatelet therapy
aspirin and clopidogrel

Outcome Measures

Primary Outcome Measures

  1. A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, disabling bleeding, life-threatening bleeding and major bleeding [1 year]

    a composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, disabling bleeding, life-threatening bleeding and major bleeding

  2. Rates of prosthetic valve thrombosis detected by 4D-CT [1 year]

Secondary Outcome Measures

  1. A composite of all-cause mortality, myocardial infarction, stroke, TIA and peripheral artery thrombosis [1 year]

    a composite of all-cause mortality, myocardial infarction, stroke, TIA and peripheral artery thrombosis

  2. Disabling bleeding, life-threatening bleeding, and major bleeding [1 year]

    disabling bleeding, life-threatening bleeding and major bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Successful TAVR (VARC 3)

  • Self-expanding prosthetic valve

  • Written informed consent provided

Exclusion Criteria:

  • patients with indications for anticoagulation therapy, such as atrial fibrillation;

  • patients with indications for double antiplatelet therapy, such as myocardial infarction within 1 year, percutaneous coronary intervention within 6 months, or peripheral artery stent implantation within 3 months;

  • patients need concomitant PCI during the index hospitalization;

  • patients with peptic ulcers or active bleeding;

  • patients with ischemic stroke or TIA within 6 months;

  • patients with a history of cerebral hemorrhage;

  • patients allergic to aspirin, clopidogrel, or Vitamin-K antagonists;

  • patients with creatinine clearance rate<15ml/min (Cockcroft formula) or need dialysis;

  • patients' life expectancy less than 1 year;

  • patients who already participated in other clinical trials.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • China National Center for Cardiovascular Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yongjian Wu, Director of coronary artery disease center, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT05375474
Other Study ID Numbers:
  • CSC-20220504
First Posted:
May 16, 2022
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Thrombosis

Study Results

No Results Posted as of May 23, 2022