The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

Phase 4UnknownNCT04501900

Shanghai Zhongshan Hospital2,106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,106

Conditions

Cardiovascular Diseases

Interventions

ClopidogrelDRUG

Study subjects diagnosed as stable, unstable ischemic coronary disease or myocardial infarction planning to undergo percutaneous coronary intervention (PCI) and no contradiction to prolonged DAPT are eligible for this trial. All subjects will provide written informed consent to participate. Subjects will be enrolled into the study before or within 24 hours after the index procedure. Subjects will be randomized to either discontinue P2Y12 inhibitor (clopidogrel or ticagrelor) (12 months total) or receive P2Y12 inhibitor for an additional 24 months (36 months total). Aspirin will be maintained in the entire study and can be replaced by cilostazol or indobufen if subjects are intolerant. Dosage of antiplatelet drugs will be according to local standard of practice. Subjects will be treated with XINSORB BRS only.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

MACE

The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization

Time frame: 3 years

BARC type 3, 4, and 5 bleeding events

Time frame: 3 years

Data from ClinicalTrials.gov

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