Back to results

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

Primary Purpose

Transcatheter Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Oral anticoagulation therapy

Single antiplatelet therapy

About this trial

This is an interventional treatment trial for Transcatheter Aortic Valve Replacement

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fuwai hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral anticoagulation therapy group

Single antiplatelet therapy group

Arm Description

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

Aspirin, 75-100mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Cardiac death

Minor bleeding (BRAC 2)

Bleeding (BRAC 1, 2, 3a-c, 5)

All-cause mortality

Myocardial infarction

Stroke

TIA

Peripheral artery thrombosis

Intracardiac thrombosis

Major bleeding (BARC 3a)

Disabling/life-threatening bleeding (BARC 3b,3c,5)

Full Information

NCT ID

NCT05375474

First Posted

May 11, 2022

Last Updated

October 18, 2023

Sponsor

China National Center for Cardiovascular Diseases

1. Study Identification

Unique Protocol Identification Number

NCT05375474

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 27, 2023 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transcatheter Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral anticoagulation therapy group

Arm Type

Experimental

Arm Description

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

Arm Title

Single antiplatelet therapy group

Arm Type

Active Comparator

Arm Description

Aspirin, 75-100mg

Intervention Type

Drug

Intervention Name(s)

Oral anticoagulation therapy

Intervention Description

Vitamin-K antagonists (warfarin)

Intervention Type

Drug

Intervention Name(s)

Single antiplatelet therapy

Intervention Description

Aspirin

Primary Outcome Measure Information:

Title

Description

Time Frame

1 year

Title

Rates of bioprosthetic valve thrombosis detected by 4D-CT

Time Frame

1 year

Secondary Outcome Measure Information:

Title

A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis

Description

A composite of all-cause mortality, myocardial infarction, stroke, TIA, peripheral artery thrombosis, intracardiac thrombosis

Time Frame

1 year

Title

Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)

Description

Major bleeding (BARC 3a), and disabling/life-threatening bleeding (BARC 3b,3c,5)

Time Frame

1 year

Title

Cardiac death

Description

Cardiac death

Time Frame

1 year

Title

Minor bleeding (BRAC 2)

Description

Minor bleeding (BRAC 2)

Time Frame

1 year

Title

Bleeding (BRAC 1, 2, 3a-c, 5)

Description

Bleeding (BRAC 1, 2, 3a-c, 5)

Time Frame

1 year

Title

All-cause mortality

Description

All-cause mortality

Time Frame

1 year

Title

Myocardial infarction

Description

Myocardial infarction

Time Frame

1 year

Title

Stroke

Description

Stroke

Time Frame

1 year

Title

TIA

Description

TIA

Time Frame

1 year

Title

Peripheral artery thrombosis

Description

Peripheral artery thrombosis

Time Frame

1 year

Title

Intracardiac thrombosis

Description

Intracardiac thrombosis

Time Frame

1 year

Title

Major bleeding (BARC 3a)

Description

Major bleeding (BARC 3a)

Time Frame

1 year

Title

Disabling/life-threatening bleeding (BARC 3b,3c,5)

Description

Disabling/life-threatening bleeding (BARC 3b,3c,5)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongjian Wu, MD,PhD

Phone

+86 13701387189

yongjianwu_nccd@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yunqing Ye, Master

Phone

+86 13699282532

judia8510@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongjian Wu, MD,PhD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yunqing Ye, Master

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Fuwai hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongjian Wu, MD, PhD

Phone

+86 13701387189

yongjianwu_nccd@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs