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

Harbin Medical University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Clopidogrel and aspirin dual-antiplatelet therapy; Drug: Aspirin monotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04624854

DAPT-MVD-201912

Details and patient eligibility

About

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.

Enrollment: 8,250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,250 participants in 2 patient groups, including a placebo group

Aspirin monotherapy

Placebo Comparator group

Description:

Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.

Treatment:

Drug: Aspirin monotherapy

Clopidogrel and aspirin dual-antiplatelet therapy

Experimental group

Description:

Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.

Treatment:

Drug: Clopidogrel and aspirin dual-antiplatelet therapy