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Coronary Artery DiseasePhase 4NCT04624854

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

A Phase 4 study testing Clopidogrel and aspirin dual-antiplatelet therapy and Aspirin monotherapy in people with Coronary Artery Disease and Myocardial Ischemia, run by Harbin Medical University at 97 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Clopidogrel and aspirin dual-antiplatelet therapy and Aspirin monotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,250 participants
Where
97 sitesChina
Study dates
28 Oct 2020to 23 Sep 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The enrolled subjects must meet all of the following criteria:
  • Aged 18-75 years old (inclusive).
  • Patients with MVD who underwent DES implantation for 12 months.
  • 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.
  • Patients have signed informed consent.

Who cannot join

  • Subjects who meet any one of the following criteria are excluded from the study:
  • Planned to use of ADP receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol.
  • Contraindication to ADP receptor blockers or aspirin.
  • Planned to use anticoagulants during the study period.
  • Planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period.
  • Planned major cardiac or non-cardiac surgery during the study period.
Show all 20Show fewer
  • Concomitant oral or intravenous therapy with CYP2C19 medium or strong inhibitors.
  • Known severe liver disease(ALT/AST is 3 times above normal).
  • Subjects with renal failure who required or anticipated dialysis during the study period.
  • Platelet count <50×10^9/L.
  • 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.
  • Pregnancy or lactation or planned to pregnant during the study period.
  • Life expectancy < 1 year.
  • 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).
  • Concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse).
  • Participation in another clinical study and did not reach the major endpoint.
  • Involvement in the planning and/or conduct of the study.

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

China97 sites

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061014

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Third Betune Hospital of Jilin University

    Changchun, Jilin, 130033

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, 067000

  • Pingquan County Hospital

    Chengde, Hebei, 067500

  • Xinqiao Hospital, Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Central Hospital of Dalian University of Technology (Dalian municipal central hospital )

    Dalian, Liaoning, 116089

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

    Daqing, Heilongjiang, 163001

  • Daqing People's Hosipital

    Daqing, Heilongjiang, 163316

  • Dazhou Central Hospital

    Dazhou, Sichuan, 635099

  • Shandong Healthcare Group Feicheng Hospital

    Feicheng, Shandong, 271608

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian, 350001

  • First People's Hospital of Fuzhou

    Fuzhou, Jiangxi, 344000

  • Central South University Xiangya School of Medicine Affiliated Haikou Hospital

    Haikou, Hainan, 570208

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

    Haikou, Hainan, 570311

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570311

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The First Hospital of Harbin

    Harbin, Heilongjiang, 150010

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang, 150030

  • The Second Hospital of Harbin

    Harbin, Heilongjiang, 150056

  • Harbin 242 Hospital

    Harbin, Heilongjiang, 150066

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • Beidahuang Industry Group General Hospital

    Harbin, Heilongjiang, 150088

  • Shuangcheng People's Hospital

    Harbin, Heilongjiang, 150100

  • Hegang Hekuang Hospital

    Hegang, Heilongjiang, 154100

  • People's Hospital of Hegang City

    Hegang, Heilongjiang, 154100

  • The Baoquanling Hospital of Beidahuang Group

    Hegang, Heilongjiang, 154211

  • Nenjiang People's Hospital

    Heihe, Heilongjiang, 161400

  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 421001

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia, 010017

  • Hulunbuir People's Hospital

    Hulunbuir, Inner Mongolia, 021008

  • Jiamusi Central Hospital

    Jiamusi, Heilongjiang, 150086

  • The First Affiliated Hospital of Jiamusi University

    Jiamusi, Heilongjiang, 154002

  • Jiansanjiang Hospital of Beidahuang Group

    Jiamusi, Heilongjiang, 156300

  • Jilin Central General Hospital

    Jilin City, Jilin, 132011

  • Jilin Hospital of Chinese and Western Medicine

    Jilin City, Jilin, 132012

  • The Fifth People's Hospital of Jinan

    Jinan, Shandong, 250022

  • Shandong Second Provincial General Hospital

    Jinan, Shandong, 250031

  • The Fourth People's Hospital of Jinan

    Jinan, Shandong, 250031

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250063

  • Jixi Jikuang Hospital

    Jixi, Heilongjiang, 158100

  • Jixi People's Hospital

    Jixi, Heilongjiang, 158100

  • Kaifeng Central Hospital

    Kaifeng, Henan, 475001

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222002

  • The Second People's Hospital of Liaocheng

    Liaocheng, Shandong, 252699

  • Mishan People's Hospital

    Mishan, Heilongjiang, 158300

  • Mudanjiang City Second People's Hospital

    Mudanjiang, Heilongjiang, 157000

  • Hongqi Hospital Affiliated to Mudanjiang Medical University

    Mudanjiang, Heilongjiang, 157011

  • Mudanjiang Cardiovascular Hospital

    Mudanjiang, Heilongjiang, 157011

  • Mudanjiang First People's Hospital

    Mudanjiang, Heilongjiang, 157011

  • Mudanjiang Hospital of Beidahuang Group

    Mudanjiang, Heilongjiang, 158322

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

  • Nanyang First People's Hospital

    Nanyang, Henan, 473004

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan, 473007

  • Affiliated Pizhou Hospital of Xuzhou Medical University

    Pizhou, Jiangsu, 221300

  • Puyang People's Hospital

    Puyang, Henan, 457000

  • Qiqihar Jianhua Hospital

    Qiqihar, Heilongjiang, 161000

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang, 161000

  • The First Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang, 161006

  • Zhongshan Hospital Wusong Branch, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • First People's Hospital of Shangqiu

    Shangqiu, Henan, 476005

  • Central Hospital of Yongcheng

    Shangqiu, Henan, 476610

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 052306

  • The Third Hospital of Shijiazhuang

    Shijiazhuang, Hebei, 052360

  • Shuangyashan Mining Group Hospital

    Shuangyashan, Heilongjiang, 155100

  • Shuangyashan People's Hospital

    Shuangyashan, Heilongjiang, 155100

  • Baoqing County People's Hospital

    Shuangyashan, Heilongjiang, 155600

  • The Hongxinglong Hospital of Beidahuang Group

    Shuangyashan, Heilongjiang, 155811

  • Songyuan Central Hospital

    Songyuan, Jilin, 138001

  • The First Hospital of Suihua City

    Suihua, Heilongjiang, 152053

  • The Affiliated Taian City Centeral Hospital of Qingdao University

    Tai’an, Shandong, 271099

  • Tangshan Central Hospital

    Tangshan, Hebei, 063099

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300222

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

  • The Fifth Hospital of Xiamen

    Xiamen, Fujian, 361101

  • People's Hospital of Daxing'anling Region

    Xing'anling, Heilongjiang, 165000

  • The Second Affiliated Hospital of Xingtai Medical College

    Xingtai, Hebei, 054000

  • Xinxiang Second People's Hospital

    Xinxiang, Henan, 453099

  • Yichang Central People's Hospital

    Yichang, Hubei, 443000

  • Tieli Medical Service Community Central Hospital

    Yichun, Heilongjiang, 152500

  • The First Hospital of Yichun City

    Yichun, Heilongjiang, 153000

  • Yichun Forestry Central Hospital

    Yichun, Heilongjiang, 153000

  • General Hospital of Ningxia Medical University - Cardiovascular and Cerebrovascular Hospital

    Yinchuan, Ningxia, 750002

  • The People's Hospital of Yongcheng

    Yongcheng, Henan, 476600

  • The 7th People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450016

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Guangdong Provincial People's Hospital

    Zhongshan, Guangdong, 510080

  • Dancheng County People's Hospital

    Zhoukou, Henan, 477150

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563003

Other trials in China

About this study

Official title: 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.

Being tested
Clopidogrel and aspirin dual-antiplatelet therapy, Aspirin monotherapy
Keywords
Coronary multivessel disease, Dual antiplatelet therapy, Percutaneous coronary intervention
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clopidogrel and aspirin dual-antiplatelet therapyDrug

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

  • Aspirin monotherapyDrug

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

Study groups in NCT04624854
Study groupRoleWhat they receive
Aspirin monotherapyPlacebo comparatorPatients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.
Receives: Drug: Aspirin monotherapy
Clopidogrel and aspirin dual-antiplatelet therapyExperimentalPatients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
Receives: Drug: Clopidogrel and aspirin dual-antiplatelet therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (9)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start28 Oct 2020
  3. Primary completion23 Sep 2025
  4. Study completion23 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
8,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624854
Sponsor's protocol ID
DAPT-MVD-201912
Status last verified
Nov 2025
First submitted
27 Oct 2020
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tian J, Wang Z, Wang Y, Wang F, Peng X, Xiao J, Li C, Hou X, Tong Q, Yu X, Gao G, Zhao P, Zhao J, Liu Y, Qin Z, Lu H, Zhang S, Li S, Weng Z, Tang H, He Y, Zhang C, Liu Y, Jiang J, Zhang J, Cai L, Xiu L, Mintz GS, Wang D, Stone GW, Yu B; DAPT-MVD Trial Investigators. Extended Dual Antiplatelet Therapy for Multivessel Coronary Artery Disease. N Engl J Med. 2026 Jul 16;395(3):233-242. doi: 10.1056/NEJMoa2517588.

    PubMed 42456136

  • 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.

    PubMed 39587825

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel and aspirin dual-antiplatelet therapy and Aspirin monotherapy in people with Coronary Artery Disease and Myocardial Ischemia, run by Harbin Medical University at 97 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke). (time frame: Through study completion, median follow-up duration is 34.3 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624854, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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