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NCT Number: NCT04624854

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clopidogrel and aspirin dual-antiplatelet therapy

Drug

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

Aspirin monotherapy

Drug

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

Primary outcomes

  1. Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke).

    Time frame: 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 outcomes

  1. Incidence of all-cause mortality.

    Time frame: 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.

  2. Incidence of cardiovascular death.

    Time frame: 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.

  3. Incidence of nonfatal myocardial infarction.

    Time frame: 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.

  4. Incidence of nonfatal stroke.

    Time frame: 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.

  5. Incidence of NACE (net adverse clinical events).

    Time frame: 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.

  6. Incidence of cardiovascular death or hospitalization.

    Time frame: 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.

  7. Incidence of emergency revascularization.

    Time frame: 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.

  8. Incidence of repeat revascularization.

    Time frame: 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.

  9. Incidence of definite/possible stent thrombosis.

    Time frame: 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.

Other outcomes

  1. Incidence of clinically relevant bleeding events.

    Time frame: 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.

  2. Incidence of major bleeding events.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Collaborators

  • Chinese Society of Cardiology
  • Lepu Medical Technology (Beijing) Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2020
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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