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Dual Anti-Platelet Therapy in...

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

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2025-09-23

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 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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Detailed Description

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Aspirin monotherapy

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

Group Type PLACEBO_COMPARATOR

Aspirin monotherapy

Intervention Type DRUG

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

Clopidogrel and aspirin dual-antiplatelet therapy

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

Group Type EXPERIMENTAL

Clopidogrel and aspirin dual-antiplatelet therapy

Intervention Type DRUG

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

Interventions

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Clopidogrel and aspirin dual-antiplatelet therapy

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

Intervention Type DRUG

Aspirin monotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Yu Bo

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Yu, M.D.,FACC

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Locations

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Xinqiao Hospital, Army Medical University

Chongqing, Chongqing Municipality, China

Site Status

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

Site Status

The Fifth Hospital of Xiamen

Xiamen, Fujian, China

Site Status

Guangdong Provincial People's Hospital

Zhongshan, Guangdong, China

Site Status

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Site Status

Central South University Xiangya School of Medicine Affiliated Haikou Hospital

Haikou, Hainan, China

Site Status

Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University)

Haikou, Hainan, China

Site Status

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Site Status

Cangzhou Central Hospital

Cangzhou, Hebei, China

Site Status

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

Site Status

Pingquan County Hospital

Chengde, Hebei, China

Site Status

Harrison International Peace Hospital

Hengshui, Hebei, China

Site Status

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The Third Hospital of Shijiazhuang

Shijiazhuang, Hebei, China

Site Status

Tangshan Central Hospital

Tangshan, Hebei, China

Site Status

The Second Affiliated Hospital of Xingtai Medical College

Xingtai, Hebei, China

Site Status

The Fifth Affiliated Hospital of Qiqihar Medical College, Daqing Longnan Hospital.

Daqing, Heilongjiang, China

Site Status

Daqing People's Hosipital

Daqing, Heilongjiang, China

Site Status

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

The First Hospital of Harbin

Harbin, Heilongjiang, China

Site Status

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

Site Status

The Second Hospital of Harbin

Harbin, Heilongjiang, China

Site Status

Harbin 242 Hospital

Harbin, Heilongjiang, China

Site Status

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Beidahuang Industry Group General Hospital

Harbin, Heilongjiang, China

Site Status

Shuangcheng People's Hospital

Harbin, Heilongjiang, China

Site Status

Hegang Hekuang Hospital

Hegang, Heilongjiang, China

Site Status

People's Hospital of Hegang City

Hegang, Heilongjiang, China

Site Status

The Baoquanling Hospital of Beidahuang Group

Hegang, Heilongjiang, China

Site Status

Nenjiang People's Hospital

Heihe, Heilongjiang, China

Site Status

Jiamusi Central Hospital

Jiamusi, Heilongjiang, China

Site Status

The First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, China

Site Status

Jiansanjiang Hospital of Beidahuang Group

Jiamusi, Heilongjiang, China

Site Status

Jixi Jikuang Hospital

Jixi, Heilongjiang, China

Site Status

Jixi People's Hospital

Jixi, Heilongjiang, China

Site Status