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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Acute Coronary Syndrome; Syndrome Heart Disease
• Intervention / Treatment: Drug: Aspirin monotherapy; Drug: Clopidogrel and aspirin dual-antiplatelet therapy

• Study Type: Interventional
• Enrollment (Actual): 8250
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400042
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing Municipality, China, 400037
      • Xinqiao Hospital, Army Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fuzhou University Affiliated Provincial Hospital
    • Xiamen, Fujian, China, 361101
      • The Fifth Hospital of Xiamen
  • Guangdong
    • Zhongshan, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
  • Guizhou
    • Zunyi, Guizhou, China, 563003
      • Affiliated Hospital of Zunyi Medical University
  • Hainan
    • Haikou, Hainan, China, 570311
      • The Second Affiliated Hospital of Hainan Medical University
    • Haikou, Hainan, China, 570208
      • Central South University Xiangya School of Medicine Affiliated Haikou Hospital
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University)
  • Hebei
    • Cangzhou, Hebei, China, 061014
      • Cangzhou Central Hospital
    • Chengde, Hebei, China, 067000
      • Affiliated Hospital of Chengde Medical University
    • Chengde, Hebei, China, 067500
      • Pingquan County Hospital
    • Hengshui, Hebei, China, 053000
      • Harrison International Peace Hospital
    • Shijiazhuang, Hebei, China, 052306
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 052360
      • The Third Hospital of Shijiazhuang
    • Tangshan, Hebei, China, 063099
      • Tangshan Central Hospital
    • Xingtai, Hebei, China, 054000
      • The Second Affiliated Hospital of Xingtai Medical College
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163316
      • Daqing People's Hosipital
    • Daqing, Heilongjiang, China, 163001
      • The Fifth Affiliated Hospital of Qiqihar Medical College, Daqing Longnan Hospital.
    • Harbin, Heilongjiang, China, 150086
      • The Second Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150010
      • The First Hospital of Harbin
    • Harbin, Heilongjiang, China, 150030
      • Heilongjiang Provincial Hospital
    • Harbin, Heilongjiang, China, 150066
      • Harbin 242 Hospital
    • Harbin, Heilongjiang, China, 150100
      • Shuangcheng People's Hospital
    • Harbin, Heilongjiang, China, 150056
      • The Second Hospital of Harbin
    • Harbin, Heilongjiang, China, 150088
      • Beidahuang Industry Group General Hospital
    • Hegang, Heilongjiang, China, 154100
      • Hegang Hekuang Hospital
    • Hegang, Heilongjiang, China, 154100
      • People's Hospital of Hegang City
    • Hegang, Heilongjiang, China, 154211
      • The Baoquanling Hospital of Beidahuang Group
    • Heihe, Heilongjiang, China, 161400
      • Nenjiang People's Hospital
    • Jiamusi, Heilongjiang, China, 154002
      • The First Affiliated Hospital of Jiamusi University
    • Jiamusi, Heilongjiang, China, 150086
      • Jiamusi Central Hospital
    • Jiamusi, Heilongjiang, China, 156300
      • Jiansanjiang Hospital of Beidahuang Group
    • Jixi, Heilongjiang, China, 158100
      • Jixi People's Hospital
    • Jixi, Heilongjiang, China, 158100
      • Jixi Jikuang Hospital
    • Mishan, Heilongjiang, China, 158300
      • Mishan People's Hospital
    • Mudanjiang, Heilongjiang, China, 157000
      • Mudanjiang City Second People's Hospital
    • Mudanjiang, Heilongjiang, China, 157011
      • Mudanjiang Cardiovascular Hospital
    • Mudanjiang, Heilongjiang, China, 157011
      • Mudanjiang First People's Hospital
    • Mudanjiang, Heilongjiang, China, 157011
      • Hongqi Hospital Affiliated to Mudanjiang Medical University
    • Mudanjiang, Heilongjiang, China, 158322
      • Mudanjiang Hospital of Beidahuang Group
    • Qiqihar, Heilongjiang, China, 161000
      • Qiqihar Jianhua Hospital
    • Qiqihar, Heilongjiang, China, 161000
      • The Third Affiliated Hospital of Qiqihar Medical University
    • Qiqihar, Heilongjiang, China, 161006
      • The First Affiliated Hospital of Qiqihar Medical University
    • Shuangyashan, Heilongjiang, China, 155100
      • Shuangyashan People's Hospital
    • Shuangyashan, Heilongjiang, China, 155100
      • Shuangyashan Mining Group Hospital
    • Shuangyashan, Heilongjiang, China, 155600
      • Baoqing County People's Hospital
    • Shuangyashan, Heilongjiang, China, 155811
      • The Hongxinglong Hospital of Beidahuang Group
    • Suihua, Heilongjiang, China, 152053
      • The First Hospital of Suihua City
    • Xing'anling, Heilongjiang, China, 165000
      • People's Hospital of Daxing'anling Region
    • Yichun, Heilongjiang, China, 153000
      • Yichun Forestry Central Hospital
    • Yichun, Heilongjiang, China, 152500
      • Tieli Medical Service Community Central Hospital
    • Yichun, Heilongjiang, China, 153000
      • The First Hospital of Yichun City
  • Henan
    • Kaifeng, Henan, China, 475001
      • Kaifeng Central Hospital
    • Nanyang, Henan, China, 473007
      • The First Affiliated Hospital of Nanyang Medical College
    • Nanyang, Henan, China, 473004
      • Nanyang First People's Hospital
    • Puyang, Henan, China, 457000
      • Puyang People's Hospital
    • Shangqiu, Henan, China, 476610
      • Central Hospital of Yongcheng
    • Shangqiu, Henan, China, 476005
      • First People's Hospital of Shangqiu
    • Xinxiang, Henan, China, 453099
      • Xinxiang Second People's Hospital
    • Yongcheng, Henan, China, 476600
      • The People's Hospital of Yongcheng
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450016
      • The 7th People's Hospital of Zhengzhou
    • Zhoukou, Henan, China, 477150
      • Dancheng County People's Hospital
  • Hubei
    • Yichang, Hubei, China, 443000
      • Yichang Central People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
    • Hengyang, Hunan, China, 421001
      • The First Affiliated Hospital of University of South China
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010017
      • Inner Mongolia Autonomous Region People's Hospital
    • Hulunbuir, Inner Mongolia, China, 021008
      • Hulunbuir People's Hospital
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222002
      • The First People's Hospital of Lianyungang
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital, Southeast University
    • Pizhou, Jiangsu, China, 221300
      • Affiliated Pizhou Hospital of Xuzhou Medical University
  • Jiangxi
    • Fuzhou, Jiangxi, China, 344000
      • First People's Hospital of Fuzhou
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
    • Changchun, Jilin, China, 130033
      • The Third Betune Hospital of Jilin University
    • Jilin, Jilin, China, 132011
      • Jilin Central General Hospital
    • Jilin, Jilin, China, 132012
      • Jilin Hospital of Chinese and Western Medicine
    • Songyuan, Jilin, China, 138001
      • Songyuan Central Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • First Affiliated Hospital of Dalian Medical University
    • Dalian, Liaoning, China, 116089
      • Central Hospital of Dalian University of Technology (Dalian municipal central hospital )
  • Ningxia
    • Yinchuan, Ningxia, China, 750002
      • General Hospital of Ningxia Medical University - Cardiovascular and Cerebrovascular Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710068
      • Shaanxi Provincial People's Hospital
  • Shandong
    • Feicheng, Shandong, China, 271608
      • Shandong Healthcare Group Feicheng Hospital
    • Jinan, Shandong, China, 250063
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 250022
      • The Fifth People's Hospital of Jinan
    • Jinan, Shandong, China, 250031
      • Shandong Second Provincial General Hospital
    • Jinan, Shandong, China, 250031
      • The Fourth People's Hospital of Jinan
    • Liaocheng, Shandong, China, 252699
      • The Second People's Hospital of Liaocheng
    • Tai’an, Shandong, China, 271099
      • The Affiliated Taian City Centeral Hospital of Qingdao University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital Wusong Branch, Fudan University
  • Sichuan
    • Dazhou, Sichuan, China, 635099
      • Dazhou Central Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin Municipality, China, 300222
      • Tianjin Chest Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830001
      • People's Hospital of Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang, China, 830054
      • First Affiliated Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.	Through study completion, median follow-up duration is 34.3 months.

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.	Through study completion, median follow-up duration is 34.3 months.
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.	Through study completion, median follow-up duration is 34.3 months.
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.	Through study completion, median follow-up duration is 34.3 months.
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.	Through study completion, median follow-up duration is 34.3 months.
Incidence of NACE (net adverse clinical events).	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.	Through study completion, median follow-up duration is 34.3 months.
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.	Through study completion, median follow-up duration is 34.3 months.
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.	Through study completion, median follow-up duration is 34.3 months.
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.	Through study completion, median follow-up duration is 34.3 months.
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.	Through study completion, median follow-up duration is 34.3 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically relevant bleeding events.	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.	Through study completion, median follow-up duration is 34.3 months.
Incidence of major bleeding events.	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.	Through study completion, median follow-up duration is 34.3 months.

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Collaborators: Chinese Society of Cardiology; Lepu Medical Technology (Beijing) Co., Ltd.
• Investigators: Principal Investigator: Bo Yu, M.D.,FACC, The Second Affiliated Hospital of Harbin Medical University

Publications and helpful links

General Publications

• Tian J, Wang Z, Wang Y, Wang F, Wang Y, Zhao P, Hou X, Peng X, Tian M, Wang D, Yu B. Rationale and Design of Dual Antiplatelet Therapy in Patients with Coronary Multi-Vessel Disease (DAPT-MVD): A Multicenter, Randomized, Controlled Trial. Clin Cardiol. 2024 Dec;47(12):e70049. doi: 10.1002/clc.70049.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): September 23, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Coronary multivessel disease; Dual antiplatelet therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Coronary Disease; Acute Coronary Syndrome; Arterial Occlusive Diseases; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Ticlopidine; Thienopyridines; Clopidogrel
• Other Study ID Numbers: DAPT-MVD-201912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No