The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation (SPARTA)

Fudan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Cardiovascular Diseases

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT04501900

ZS20200804

Details and patient eligibility

About

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.

Enrollment: 2,106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,106 participants in 2 patient groups

prolonged DAPT group

Active Comparator group

Treatment:

Drug: Clopidogrel

standard DAPT group

No Intervention group