Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)
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 |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
Inclusion Criteria:
- The enrolled subjects must meet all of the following criteria:
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Aged 18-75 years old (inclusive).
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Patients with MVD who underwent DES implantation for 12 months.
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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.
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Patients have signed informed consent.
Exclusion Criteria:
- Subjects who meet any one of the following criteria are excluded from the study:
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Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol.
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Contraindication to ADP receptor blockers or aspirin.
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Planned to use anticoagulants during the study period.
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Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period.
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Planned major cardiac or non-cardiac surgery during the study period.
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Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors.
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Known severe liver disease(ALT/AST is 3 times above normal).
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Subjects with renal failure who required or anticipated dialysis during the study period.
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Platelet count <50×10^9/L.
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Patients with:
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A history of intracranial bleed or ischemic stroke at any time.
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A central nervous system tumor or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time.
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Intracranial or spinal cord surgery within 5 years.
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Pregnancy or lactation or planned to pregnant during the study period.
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Life expectancy < 1 year.
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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).
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Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse).
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Participation in another clinical study and did not reach the major endpoint.
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Involvement in the planning and/or conduct of the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- DAPT-MVD-201912