The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

Phase 4

Not yet recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Clopidogrel

• Registration Number: NCT04501900
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06
• Study Start: 2020-10
• Primary Completion: 2024-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2106

Inclusion Criteria

1. Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months
2. Written informed consent from the subjects
3. Qualified candidates for coronary bypass surgery
4. Lesions with reference vessel diameter 2.75 to 3.5 mm

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Exclusion Criteria

1. Age ≤ 18 years
2. Cardiogenetic shock
3. Chronic heart failure with a left ventricular ejection fraction ≤ 30%
4. Oral anticoagulation therapy
5. Known allergy or intolerance to the study medications
6. Malignancies and other comorbid conditions with a life expectancy less than 5 years
7. Subjects treated with both BRS and DES during the index procedure
8. Pregnant wowen
9. Planned staged PCI
10. Contemporaneous enrollment in a different clinical trial
11. Any revascularization within 1 year
12. Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment
13. Unprotected left main artery
14. Lesions located at the ostium of the main coronary artery
15. bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prolonged DAPT group	Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
MACE	3 years	The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization
BARC type 3, 4, and 5 bleeding events	3 years