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

Transcatheter Aortic Valve Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375474
• Other study ID #: CSC-20220504
• Status: Recruiting
• Phase: Phase 4
• Start date: July 27, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Yongjian Wu, MD,PhD
• Phone: +86 13701387189
• Email: yongjianwu_nccd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Antithrombotic Therapy
• Thrombosis
• Transcatheter Aortic Valve Replacement

Intervention

Drug:
• Oral anticoagulation therapy
Vitamin-K antagonists (warfarin)
• Single antiplatelet therapy
Aspirin

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rates of bioprosthetic valve thrombosis detected by 4D-CT		1 year
Secondary	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
Secondary	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
Secondary	Cardiac death	Cardiac death	1 year
Secondary	Minor bleeding (BRAC 2)	Minor bleeding (BRAC 2)	1 year
Secondary	Bleeding (BRAC 1, 2, 3a-c, 5)	Bleeding (BRAC 1, 2, 3a-c, 5)	1 year
Secondary	All-cause mortality	All-cause mortality	1 year
Secondary	Myocardial infarction	Myocardial infarction	1 year
Secondary	Stroke	Stroke	1 year
Secondary	TIA	TIA	1 year
Secondary	Peripheral artery thrombosis	Peripheral artery thrombosis	1 year
Secondary	Intracardiac thrombosis	Intracardiac thrombosis	1 year
Secondary	Major bleeding (BARC 3a)	Major bleeding (BARC 3a)	1 year
Secondary	Disabling/life-threatening bleeding (BARC 3b,3c,5)	Disabling/life-threatening bleeding (BARC 3b,3c,5)	1 year