Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)

Study Overview
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Brief Summary
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This study is a prospective, multicenter, parallel, open-label, randomized, controlled, superiority trial. It is planned to recruit 8,250 patients with multi-vessel disease(MVD), and the patients will be followed-up for 12 months after being implanted with a drug-eluting stent (DES) at one of 100 different centers. All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete randomization.

Official Title
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Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD): A Prospective, Multicenter, Randomized, Controlled Trial

Conditions
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Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Syndrome Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Coronary Disease, Vascular Diseases

Intervention / Treatment
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* Drug: Clopidogrel and Aspirin dual-antiplatelet therapy
* Drug: Aspirin monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The enrolled subjects must meet all of the following criteria: Aged 18-75 years old (inclusive). Patients with MVD who underwent DES implantation for 12 months. Patients have been treated with aspirin and can tolerant of aspirin at doses of 75-150 mg/day as maintenance therapy during the study period. Patients have signed informed consent. Exclusion Criteria: - Subjects who meet any one of the following criteria are excluded from the study: Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol. Contraindication to ADP receptor blockers or aspirin. Planned to use anticoagulants during the study period. Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period. Planned major cardiac or non-cardiac surgery during the study period. Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors. Known severe liver disease(ALT/AST is 3 times above normal). Subjects with renal failure who required or anticipated dialysis during the study period. Platelet count <50×10^9/L. Patients with: A history of intracranial bleed or ischemic stroke at any time. A central nervous system tumor or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time. Intracranial or spinal cord surgery within 5 years. Pregnancy or lactation or planned to pregnant during the study period. Life expectancy < 1 year. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer). Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse). Participation in another clinical study and did not reach the major endpoint. Involvement in the planning and/or conduct of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete randomization. The treatment group will use aspirin + clopidogrel dual anti-platelet therapy for 12 months, and the control group will use aspirin monotherapy for 12 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Aspirin monotherapy<br>Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization. | Drug: Aspirin monotherapy<br>* Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.<br>|
| Experimental: Clopidogrel and Aspirin dual-antiplatelet therapy<br>Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization. | Drug: Clopidogrel and Aspirin dual-antiplatelet therapy<br>* Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke). | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of MACCE in patients with MVD | 12 months after randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all-cause mortality. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of all-cause mortality in patients with MVD. | 12 months after randomization. | 
| Incidence of cardiovascular death. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of cardiovascular death in patients with MVD. | 12 months after randomization. | 
| Incidence of nonfatal myocardial infarction. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of nonfatal myocardial infarction in patients with MVD. | 12 months after randomization. | 
| Incidence of nonfatal stroke. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of nonfatal stroke in patients with MVD. | 12 months after randomization. | 
| Incidence of clinical adverse events. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of clinical adverse events (MACCE and BARC defined as type 2-5) in patients with MVD. | 12 months after randomization. | 
| Incidence of cardiovascular death or hospitalization. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of cardiovascular death or hospitalization (myocardial infarction, stroke, emergency revascularization, unstable angina or TIA) caused by thrombotic events in patients with MVD. | 12 months after randomization. | 
| Incidence of emergency revascularization. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of emergency revascularization in patients with MVD. | 12 months after randomization. | 
| Incidence of repeat revascularization. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of any repeat revascularization in patients with MVD. | 12 months after randomization. | 
| Incidence of definite/possible stent thrombosis. | To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of definite/possible stent thrombosis in patients with MVD. | 12 months after randomization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual antiplatelet therapy, Percutaneous coronary intervention, Coronary multivessel disease