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

Sponsor
Harbin Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04624854
Collaborator
Chinese Society of Cardiology (Other), Lepu Medical Technology (Beijing) Co., Ltd. (Industry)
8,250
109
2
35.9
75.7
2.1

Study Details

Study Description

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 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 complete randomization.

Condition or Disease Intervention/Treatment Phase
  • Drug: Clopidogrel and Aspirin dual-antiplatelet therapy
  • Drug: Aspirin monotherapy
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete 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.All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete 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.
Masking:
None (Open Label)
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: 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; The statisticians are independent and blind to the grouping information.
Primary Purpose:
Treatment
Official Title:
Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD): A Prospective, Multicenter, Randomized, Controlled Trial
Actual Study Start Date :
Oct 27, 2020
Anticipated Primary Completion Date :
Oct 26, 2023
Anticipated Study Completion Date :
Oct 26, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke). [12 months after randomization.]

    To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of MACCE in patients with MVD

Secondary Outcome Measures

  1. Incidence of all-cause mortality. [12 months after randomization.]

    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. [12 months after randomization.]

    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. [12 months after randomization.]

    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. [12 months after randomization.]

    To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of nonfatal stroke in patients with MVD.

  5. Incidence of clinical adverse events. [12 months after randomization.]

    To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of clinical adverse events (MACCE and BARC defined as type 2-5) in patients with MVD.

  6. Incidence of cardiovascular death or hospitalization. [12 months after randomization.]

    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. [12 months after randomization.]

    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. [12 months after randomization.]

    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. [12 months after randomization.]

    To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of definite/possible stent thrombosis in patients with MVD.

Other Outcome Measures

  1. Incidence of clinically relevant bleeding events. [12 months after randomization.]

    To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of clinically relevant bleeding events (BARC, defined as type 2-5) in patients with MVD.

  2. Incidence of major bleeding events. [12 months after randomization.]

    To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of major bleeding events (BARC, defined as type3-5) in patients with MVD.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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.

  1. Pregnancy or lactation or planned to pregnant during the study period.

  2. Life expectancy < 1 year.

  3. 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).

  4. Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse).

  5. Participation in another clinical study and did not reach the major endpoint.

  6. Involvement in the planning and/or conduct of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Beijing Luhe Hospital of Capital Medical University Beijing Beijing China 101149
2 The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400042
3 The Second Affiliated Hospital of Army Medical University Chongqing Chongqing China 516562
4 Fujian Provincial Hospital Fuzhou Fujian China 350001
5 Xiamen Fifth Hospital Xiamen Fujian China 361101
6 Pingquan County Hospital Qingyang Gansu China 744517
7 Shenzhen People's Hospital Shenzhen Guangdong China 518000
8 Guangdong Provincial People's Hospital Zhongshan Guangdong China 510080
9 The Eighth Affiliated Hospital, Sun Yat-Sen University Zhongshan Guangdong China 528406
10 Hezhou People's Hospital Hezuo Guangxi China 542800
11 Affiliated Hospital of Zunyi Medical University Zunyi Guizhou China 563003
12 Haikou People's Hospital Haikou Hainan China 570208
13 Hainan General Hospital Haikou Hainan China 570311
14 Cangzhou Central Hospital Cangzhou Hebei China 061014
15 Affiliated Hospital of Chengde Medical University Chengde Hebei China 067000
16 Harrison International Peace Hospital Hengshui Hebei China 053000
17 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 052306
18 The Third Hospital of Shijiazhuang Shijiazhuang Hebei China 052360
19 Tangshan Central Hospital Tangshan Hebei China 063099
20 The Second Affiliated Hospital of Xingtai Medical College Xingtai Hebei China 054000
21 Xingtai Third Hospital Xingtai Hebei China 054000
22 Daqing Long Nan Hospital Daqing Heilongjiang China 163001
23 Daqing Oilfield General Hospital Daqing Heilongjiang China 163316
24 Daqing People's Hosipital Daqing Heilongjiang China 163316
25 The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
26 Harbin First Hospital Harbin Heilongjiang China 150010
27 Heilongjiang Province Hospital Harbin Heilongjiang China 150030
28 Harbin Second Hospital Harbin Heilongjiang China 150056
29 Harbin 242 Hospital Harbin Heilongjiang China 150066
30 The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150086
31 The Second Cancer Hospital of Heilongjiang Province Harbin Heilongjiang China 150088
32 Shuangcheng People's Hospital Harbin Heilongjiang China 150100
33 Hegang Mining Group General Hospital Hegang Heilongjiang China 154100
34 Hegang People's Hospital Hegang Heilongjiang China 154100
35 Heilongjiang Provincial Agricultural Reclamation Baoquanling Administration Center Hospital Hegang Heilongjiang China 154211
36 Nenjiang People's Hospital Heihe Heilongjiang China 161400
37 The Central Hospital of Jiamusi City Jiamusi Heilongjiang China 150086
38 The First Affiliated Hospital of Jamusi University Jiamusi Heilongjiang China 154002
39 The Jiansanjiang People's Hospital of Heilongjiang Land Reclamation Jiamusi Heilongjiang China 156300
40 Jixi Jikuang Hospital Jixi Heilongjiang China 158100
41 Jixi People's Hospital Jixi Heilongjiang China 158100
42 Mishan People's Hospital Mishan Heilongjiang China 158300
43 Mudanjiang City Second People's Hospital Mudanjiang Heilongjiang China 157000
44 Hongqi Hospital of Mudanjiang Medical University Mudanjiang Heilongjiang China 157011
45 Mudanjiang Cardiovascular Hospital Mudanjiang Heilongjiang China 157011
46 Mudanjiang First People's Hospital Mudanjiang Heilongjiang China 157011
47 Mudanjiang Administration Center Hospital of Heilongjiang Land Reclamation Mudanjiang Heilongjiang China 158322
48 Qiqihar Jianhua Hospital Qiqihar Heilongjiang China 161000
49 The Third Affiliated Hospital of Qiqihar Medical University Qiqihar Heilongjiang China 161000
50 The First Affiliated Hospital of Qiqihar Medical University Qiqihar Heilongjiang China 161006
51 Emergency General Hospital of Shuangyashan Shuangyashan Heilongjiang China 155100
52 Shuangyashan People's Hospital Shuangyashan Heilongjiang China 155100
53 The People's Hospital of Baoqing Shuangyashan Heilongjiang China 155600
54 Hongxinglong Central Hospital Shuangyashan Heilongjiang China 155811
55 Suihua First Hospital Suihua Heilongjiang China 152053
56 Daxing'anling Prefecture People's Hospital Xing'anling Heilongjiang China 165000
57 Tieli People's Hospital Yichun Heilongjiang China 152500
58 Yichun First Hospital Yichun Heilongjiang China 153000
59 Yichun Forestry Central Hospital Yichun Heilongjiang China 153000
60 Kaifeng Central Hospital Kaifeng Henan China 475001
61 Nanyang First People's Hospital Nanyang Henan China 473004
62 The First Affiliated Hospital of Nanyang Medical College Nanyang Henan China 473007
63 Puyang People's Hospital Puyang Henan China 457000
64 The First People's Hospital of Shangqiu Shangqiu Henan China 476005
65 Central Hospital of Yongcheng Shangqiu Henan China 476610
66 The Second People's Hospital of Xinxiang City Xinxiang Henan China 453099
67 Yongcheng People's Hospital Yongcheng Henan China 476600
68 The Seventh People's Hospital of Zhengzhou Zhengzhou Henan China 450016
69 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
70 Dancheng People's Hospital Zhoukou Henan China 477150
71 The Fourth Hospital of Wuhan Wuhan Hubei China 430030
72 Renmin Hospital of Wuhan University Wuhan Hubei China 430060
73 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430062
74 Yichang First People's Hospital Yichang Hubei China 443000
75 The Third Xiangya Hospital of Central South University Changsha Hunan China 410013
76 The First Affiliated Hospital of University of South China Hengyang Hunan China 421001
77 The First People's Hospital of Lianyungang Lianyungang Jiangsu China 222002
78 Zhongda Hospital Southeast University Nanjing Jiangsu China 210009
79 Pizhou People's Hospital Pizhou Jiangsu China 221300
80 First People's Hospital of Fuzhou Fuzhou Jiangxi China 344000
81 The Third Affiliated Hospital of Jilin University Chang chun Jilin China 130033
82 The Second Affiliated Hospital of Jilin University Chang chun Jilin China 130041
83 Affiliated Hospital of Changchun Traditional Chinese Medicine University Changchun Jilin China 130021
84 The First Affiliated Hospital of Jilin University Changchun Jilin China 130021
85 Jilin Central Hospital Jilin Jilin China 132011
86 Jilin Integrated Traditional Chinese and Western Medicine Hospital Jilin Jilin China 132012
87 General Hospital of Jihua Group Company Jilin Jilin China 132022
88 Songyuan Central Hospital Songyuan Jilin China 138001
89 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116011
90 Dalian Municipal Cental Hospital Dalian Liaoning China 116089
91 Hulunbeir People's Hospital Hulunbeir Neimeng China 021008
92 Inner Mongolia People's Hospital Neimeng Neimeng China 010017
93 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750002
94 Feicheng Hospital of Shandong Guoxin Yiyang Group Fengcheng Shandong China 271608
95 The Fifth People's Hospital of Jinan Jinan Shandong China 250022
96 Shandong Second Provincial General Hospital Jinan Shandong China 250031
97 The Fourth People's Hospital of Jinan Jinan Shandong China 250031
98 Qilu Hospital of Shandong University Jinan Shandong China 250063
99 Yanzhou District People's Hospital Jining Shandong China 272100
100 The Second People's Hospital of Liaocheng Liaocheng Shandong China 252699
101 Taian City Central Hospital Tai'an Shandong China 271099
102 Wusong hospital Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai China 200032
103 Shanxi Provincial People's Hospital Xian Shanxi China 710068
104 Xinqiao Hospital Army Medical University Chongqing Sichuan China 400000
105 Dazhou Central Hospital Dazhou Sichuan China 635099
106 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
107 Tianjin Chest Hospital Tianjin Tianjin China 300222
108 Xinjiang Uiger Municipal People's Hospital Ürümqi Xinjiang China 830001
109 The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang China 830054

Sponsors and Collaborators

  • Harbin Medical University
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yu Bo, Director, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT04624854
Other Study ID Numbers:
  • DAPT-MVD-201912
First Posted:
Nov 12, 2020
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu Bo, Director, Harbin Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022