The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

Study Overview
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Brief Summary
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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.

Official Title
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The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months Written informed consent from the subjects Qualified candidates for coronary bypass surgery Lesions with reference vessel diameter 2.75 to 3.5 mm Exclusion Criteria: Age ≤ 18 years Cardiogenetic shock Chronic heart failure with a left ventricular ejection fraction ≤ 30% Oral anticoagulation therapy Known allergy or intolerance to the study medications Malignancies and other comorbid conditions with a life expectancy less than 5 years Subjects treated with both BRS and DES during the index procedure Pregnant wowen Planned staged PCI Contemporaneous enrollment in a different clinical trial Any revascularization within 1 year Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment Unprotected left main artery Lesions located at the ostium of the main coronary artery bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prolonged DAPT group<br> | Drug: Clopidogrel<br>* 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.<br>|
| No Intervention: standard DAPT group<br> | |

What is the study measuring?
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Primary Outcome Measures

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