Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04624854
Other study ID # DAPT-MVD-201912
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 27, 2020
Est. completion date April 30, 2025

Study information

Verified date June 2024
Source Harbin Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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 complete randomization.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 8250
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
Clopidogrel and Aspirin dual-antiplatelet therapy
Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
Aspirin monotherapy
Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.

Locations

Country Name City State
China Affiliated Beijing Luhe Hospital of Capital Medical University Beijing Beijing
China Cangzhou Central Hospital Cangzhou Hebei
China The Second Affiliated Hospital of Jilin University Chang chun Jilin
China The Third Affiliated Hospital of Jilin University Chang chun Jilin
China Affiliated Hospital of Changchun Traditional Chinese Medicine University Changchun Jilin
China The First Affiliated Hospital of Jilin University Changchun Jilin
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Affiliated Hospital of Chengde Medical University Chengde Hebei
China The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China The Second Affiliated Hospital of Army Medical University Chongqing Chongqing
China Dalian Municipal Cental Hospital Dalian Liaoning
China The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China Daqing Long Nan Hospital Daqing Heilongjiang
China Daqing Oilfield General Hospital Daqing Heilongjiang
China Daqing People's Hosipital Daqing Heilongjiang
China Dazhou Central Hospital Dazhou Sichuan
China Feicheng Hospital of Shandong Guoxin Yiyang Group Fengcheng Shandong
China First People's Hospital of Fuzhou Fuzhou Jiangxi
China Fujian Provincial Hospital Fuzhou Fujian
China The First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong
China Haikou People's Hospital Haikou Hainan
China Hainan General Hospital Haikou Hainan
China The Second Affiliated Hospital of Hainan Medical University Haikou Hainan
China Harbin 242 Hospital Harbin Heilongjiang
China Harbin First Hospital Harbin Heilongjiang
China Harbin Second Hospital Harbin Heilongjiang
China Heilongjiang Province Hospital Harbin Heilongjiang
China Shuangcheng People's Hospital Harbin Heilongjiang
China The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China The Second Cancer Hospital of Heilongjiang Province Harbin Heilongjiang
China Hegang Mining Group General Hospital Hegang Heilongjiang
China Hegang People's Hospital Hegang Heilongjiang
China Heilongjiang Provincial Agricultural Reclamation Baoquanling Administration Center Hospital Hegang Heilongjiang
China Nenjiang People's Hospital Heihe Heilongjiang
China Harrison International Peace Hospital Hengshui Hebei
China The First Affiliated Hospital of University of South China Hengyang Hunan
China Hezhou People's Hospital Hezuo Guangxi
China Hulunbeir People's Hospital Hulunbeir Neimeng
China The Central Hospital of Jiamusi City Jiamusi Heilongjiang
China The First Affiliated Hospital of Jamusi University Jiamusi Heilongjiang
China The Jiansanjiang People's Hospital of Heilongjiang Land Reclamation Jiamusi Heilongjiang
China General Hospital of Jihua Group Company Jilin Jilin
China Jilin Central Hospital Jilin Jilin
China Jilin Integrated Traditional Chinese and Western Medicine Hospital Jilin Jilin
China Qilu Hospital of Shandong University Jinan Shandong
China Shandong Second Provincial General Hospital Jinan Shandong
China The Fifth People's Hospital of Jinan Jinan Shandong
China The Fourth People's Hospital of Jinan Jinan Shandong
China Yanzhou District People's Hospital Jining Shandong
China Jixi Jikuang Hospital Jixi Heilongjiang
China Jixi People's Hospital Jixi Heilongjiang
China Kaifeng Central Hospital Kaifeng Henan
China The First People's Hospital of Lianyungang Lianyungang Jiangsu
China The Second People's Hospital of Liaocheng Liaocheng Shandong
China Mishan People's Hospital Mishan Heilongjiang
China Hongqi Hospital of Mudanjiang Medical University Mudanjiang Heilongjiang
China Mudanjiang Administration Center Hospital of Heilongjiang Land Reclamation Mudanjiang Heilongjiang
China Mudanjiang Cardiovascular Hospital Mudanjiang Heilongjiang
China Mudanjiang City Second People's Hospital Mudanjiang Heilongjiang
China Mudanjiang First People's Hospital Mudanjiang Heilongjiang
China Zhongda Hospital Southeast University Nanjing Jiangsu
China Nanyang First People's Hospital Nanyang Henan
China The First Affiliated Hospital of Nanyang Medical College Nanyang Henan
China Inner Mongolia People's Hospital Neimeng Neimeng
China Pizhou People's Hospital Pizhou Jiangsu
China Puyang People's Hospital Puyang Henan
China Pingquan County Hospital Qingyang Gansu
China Qiqihar Jianhua Hospital Qiqihar Heilongjiang
China The First Affiliated Hospital of Qiqihar Medical University Qiqihar Heilongjiang
China The Third Affiliated Hospital of Qiqihar Medical University Qiqihar Heilongjiang
China Wusong hospital Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai
China Central Hospital of Yongcheng Shangqiu Henan
China The First People's Hospital of Shangqiu Shangqiu Henan
China Shenzhen People's Hospital Shenzhen Guangdong
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China The Third Hospital of Shijiazhuang Shijiazhuang Hebei
China Emergency General Hospital of Shuangyashan Shuangyashan Heilongjiang
China Hongxinglong Central Hospital Shuangyashan Heilongjiang
China Shuangyashan People's Hospital Shuangyashan Heilongjiang
China The People's Hospital of Baoqing Shuangyashan Heilongjiang
China Songyuan Central Hospital Songyuan Jilin
China Suihua First Hospital Suihua Heilongjiang
China Taian City Central Hospital Tai'an Shandong
China Tangshan Central Hospital Tangshan Hebei
China Tianjin Chest Hospital Tianjin Tianjin
China Tianjin Medical University General Hospital Tianjin Tianjin
China The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
China Xinjiang Uiger Municipal People's Hospital Ürümqi Xinjiang
China Renmin Hospital of Wuhan University Wuhan Hubei
China The Fourth Hospital of Wuhan Wuhan Hubei
China Zhongnan Hospital of Wuhan University Wuhan Hubei
China Xiamen Fifth Hospital Xiamen Fujian
China Shanxi Provincial People's Hospital Xian Shanxi
China Daxing'anling Prefecture People's Hospital Xing'anling Heilongjiang
China The Second Affiliated Hospital of Xingtai Medical College Xingtai Hebei
China Xingtai Third Hospital Xingtai Hebei
China The Second People's Hospital of Xinxiang City Xinxiang Henan
China Yichang First People's Hospital Yichang Hubei
China Tieli People's Hospital Yichun Heilongjiang
China Yichun First Hospital Yichun Heilongjiang
China Yichun Forestry Central Hospital Yichun Heilongjiang
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Yongcheng People's Hospital Yongcheng Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China The Seventh People's Hospital of Zhengzhou Zhengzhou Henan
China Guangdong Provincial People's Hospital Zhongshan Guangdong
China The Eighth Affiliated Hospital, Sun Yat-Sen University Zhongshan Guangdong
China Dancheng People's Hospital Zhoukou Henan
China Affiliated Hospital of Zunyi Medical University Zunyi Guizhou

Sponsors (3)

Lead Sponsor Collaborator
Harbin Medical University Chinese Society of Cardiology, Lepu Medical Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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, defined as type 2-5) in patients with MVD. Through study completion, an average of 2 years.
Other Incidence of major bleeding events. 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. Through study completion, an average of 2 years.
Primary 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, an average of 2 years.
Secondary 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, an average of 2 years.
Secondary 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, an average of 2 years.
Secondary 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, an average of 2 years.
Secondary 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, an average of 2 years.
Secondary Incidence of clinical adverse events. 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. Through study completion, an average of 2 years.
Secondary 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, an average of 2 years.
Secondary 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, an average of 2 years.
Secondary 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, an average of 2 years.
Secondary 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, an average of 2 years.
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A