Acute Coronary Syndrome, Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia, Syndrome Heart Disease, Vascular Diseases
Conditions
Keywords
Coronary multivessel disease, Dual antiplatelet therapy, Percutaneous coronary intervention
Brief summary
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 at least 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 permuted completely randomization.
Interventions
Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.
DRUGClopidogrel and aspirin dual-antiplatelet therapy
Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
Sponsors
Chinese Society of Cardiology
Lepu Medical Technology (Beijing) Co., Ltd.
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial, and the investigators and subjects will not be blinded. Under these conditions, the following methods will be employed to minimize bias: 1. Clinical Endpoint Committee (CEC) is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical safety or efficacy events of interest; 2. The statisticians are independent and blind to the grouping information.
Intervention model description
All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a permuted completely 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The enrolled subjects must meet all of the following criteria: 1. Aged 18-75 years old (inclusive). 2. Patients with MVD who underwent DES implantation for 12 months. 3. 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. 4. Patients have signed informed consent.
Exclusion criteria
\- Subjects who meet any one of the following criteria are excluded from the study: 1. Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol. 2. Contraindication to ADP receptor blockers or aspirin. 3. Planned to use anticoagulants during the study period. 4. Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period. 5. Planned major cardiac or non-cardiac surgery during the study period. 6. Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors. 7. Known severe liver disease(ALT/AST is 3 times above normal). 8. Subjects with renal failure who required or anticipated dialysis during the study period. 9. Platelet count \<50×10\^9/L. 10. 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. 11. Pregnancy or lactation or planned to pregnant during the study period. 12. Life expectancy \< 1 year. 13. 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). 14. Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse). 15. Participation in another clinical study and did not reach the major endpoint. 16. Involvement in the planning and/or conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke). | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of MACCE in patients with MVD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardiovascular death. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of cardiovascular death in patients with MVD. |
| Incidence of nonfatal myocardial infarction. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of nonfatal myocardial infarction in patients with MVD. |
| Incidence of nonfatal stroke. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of nonfatal stroke in patients with MVD. |
| Incidence of all-cause mortality. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of all-cause mortality in patients with MVD. |
| Incidence of NACE (net adverse clinical events). | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of net adverse clinical events (MACCE and BARC type 2-5 bleeding) in patients with MVD. |
| Incidence of repeat revascularization. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of any repeat revascularization in patients with MVD. |
| Incidence of definite/possible stent thrombosis. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of definite/possible stent thrombosis in patients with MVD. |
| Incidence of cardiovascular death or hospitalization. | Through study completion, median follow-up duration is 34.3 months. | 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. |
| Incidence of emergency revascularization. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of emergency revascularization in patients with MVD. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically relevant bleeding events. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of clinically relevant bleeding events (BARC type 2-5 bleeding) in patients with MVD. |
| Incidence of major bleeding events. | Through study completion, median follow-up duration is 34.3 months. | To evaluate the effect of clopidogrel and aspirin dual-antiplatelet therapy on the incidence of major bleeding events (BARC type 3-5 bleeding) in patients with MVD. |
Countries
China
Outcome results
None listed