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Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and HemorrhagePhase 4OPT-BIRISKNCT03431142

Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial

A Phase 4 study testing Clopidogrel and Clopidogrel+aspirin in people with Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage, run by Shenyang Northern Hospital at 103 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

Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary. Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Clopidogrel and Clopidogrel+aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,758 participants
Where
103 sitesChina
Study dates
12 Feb 2018to 30 Dec 2020
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ACS patients undergoing PCI (New-Generation DES) and finishing 9-12 months of DAPT
  • 18 ~ 85 years old adult patients
  • Patients under the age of 65 must meet at least one of the following clinical criteria of high bleeding risk and at least one of the following clinical criteria of high ischemic risk; Patients aged 65-75 must meet one of the following clinical criteria of either high bleeding risk or high ischemic risk.
  • Clinical criteria of high bleeding risk:
  • ≥75 years old
  • female
Show all 23Show fewer
  • Iron deficiency anemia
  • history of stroke (hemorrhagic or ischemic)
  • ongoing medical treatment of diabetes (oral hypoglycemic agents or subcutaneous insulin)
  • Chronic kidney disease (eGFR <60mL/min or creatinine clearance<60mL/min)
  • Clinical criteria of high ischemic risk:
  • ≥75 years old
  • Multiple coronary lesions
  • target lesions required for stent of total length> 30mm
  • Thrombotic target lesions
  • Bifurcation lesions are Medina 0, 1, 1 or 1, 1, and 1, with stents implanted in both main branch and side branch
  • Left main coronary artery (≥50%) or proximal LAD (≥70%) lesions
  • Calcified plaques requiring endovascular excision
  • acute coronary syndrome with troponin positive
  • Previous myocardial infarction, ischemic stroke, diagnosed peripheral arterial disease (PAD), or revascularization due to coronary artery disease (CAD) / PAD
  • recurrent myocardial infarction, revascularization, stent thrombosis, stroke in the last 9 months
  • ongoing medical treatment of diabetes (oral hypoglycemic agents or subcutaneous insulin)
  • Chronic kidney disease (eGFR<60 mL/min or creatinine clearance <60 mL/min)

Who cannot join

  • Discontinuation or termination of DAPT treatment during the past 6 months due to adverse events (bleeding or ischemia) or other conditions
  • Surgery plan within 90 days
  • Coronary Revascularization (Surgical or Intervention) Program within 90 days
  • Dialysis-dependent renal failure
  • Moderate or severe hepatic insufficiency (2 times the upper limit of normal for ALT or AST)
  • Life expectancy <1 year
Show all 10Show fewer
  • Unable or unwilling to provide informed consent
  • Women with childbearing potential
  • Platelet count <100000/mm3
  • Subjects undergoing warfarin or similar anticoagulant therapy

Trial locations and contacts

103 sites in 1 country.

103 sites in 1 country

China103 sites

  • Anshan Center Hospital

    Anshan, Liaoning, 114008

  • The First Affiliated Hospital Of Baotou Medical College

    Baotou, Neimonggol, 014017

  • Baotou City Central Hospital

    Baotou, Neimonggol, 014040

  • The Seventh Medical Center of Pla General Hospital

    Beijing, Beijing Municipality, 100010

  • Beijing Anzhen Hospital,Capital Medical University, word2

    Beijing, Beijing Municipality, 100029

  • Beijing Anzhen Hospital,Capital Medical University, word3

    Beijing, Beijing Municipality, 100029

  • PLA Rocket Force Characteristic Medical Center

    Beijing, Beijing Municipality, 100088

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

  • Beijing Chao-Yang Hospital,Capital Medical University

    Beijing, 100020

  • Beijing Anzhen Hospital,Capital Medical University， word1

    Beijing, 100029

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Beijing, 100037

  • Peking University People's Hospital

    Beijing, 100044

  • The Sixth Medical Center of PLA General Hospital

    Beijing, 100048

  • Beijing Hospital

    Beijing, 100730

  • Beijing Tongren Hospital,CMU

    Beijing, 100730

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, 101199

  • Benxi Central Hospital

    Benxi, Liaoning, 117099

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061011

  • The First Bethune Hospital Of Jilin University

    Changchun, Jilin, 130021

  • China-Japan Union Hospital Of Jilin University

    Changchun, Jilin, 130033

  • The Second Hospital Of Jilin University

    Changchun, Jilin, 130041

  • People's Hospital Of Hunan Province

    Changsha, Hunan, 410005

  • The Third Xiangya Hospital Of Central South University

    Changsha, Hunan, 410205

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital, word 1

    Chengdu, Sichuan, 610072

  • Sichuan Provincial People's Hospital, word 2

    Chengdu, Sichuan, 610072

  • The General Hospital Of Western Theater Command PLA

    Chengdu, Sichuan, 610083

  • Xinqiao Hospital Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • Department of Cardiology, Daping Hospital, The Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • University-Town Hospital Of Chongqing Medical University

    Chongqing, Chongqing Municipality, 401331

  • The First Affiliated Hospital Of Dalian Medical University

    Dalian, Liaoning, 116011

  • The Second Hospital Of Dalian Medical University

    Dalian, Liaoning, 116023

  • Dalian Friendship Hospital

    Dalian, Liaoning, 116100

  • Dandong Central Hospital

    Dandong, Liaoning, 118002

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Guangzhou Red Cross Hospital

    Guangzhou, Guangdong, 510235

  • The First Affiliated Hospital, Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310003

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017

  • Inner Mongolia People's Hospital

    Hohhot, Neimonggol, 010017

  • HulunBuir People's Hospital

    Hulunbuir, Inner Mongolia, 021008

  • Inner Mongolia Forestry General Hospital

    Hulunbuir, Inner Mongolia, 022150

  • Jilin Central General Hospital

    Jilin City, Jilin, 132011

  • Jilin City Hospital Of Chemical Industry, word1

    Jilin City, Jilin, 132021

  • Jilin City Hospital Of Chemical Industry, word2

    Jilin City, Jilin, 132021

  • Central Hospital Affiliated To Shandong First Medical University

    Jinan, Shandong, 250013

  • The General Hospital Of Jinan Military Command

    Jinan, Shandong, 250031

  • Qilu Hospital Of Shandong University

    Jinan, Shandong, 250063

  • Linfen Central Hospital

    Linfen, Shanxi, 041099

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545007

  • Meihekou Central Hospital

    Meihekou, Jilin, 135099

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Nanjing Jinling Hospital

    Nanjing, Jiangsu, 210016

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai Municipality, 200011

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200020

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

  • Shanghai Sixth People's Hospital Affiliated To Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200235

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • The First Affiliated Hospital Of Liaoning University Of Traditional Chinese Medicine

    Shenyang, Liaoning, 110000

  • The First Hospital Of China Medical University

    Shenyang, Liaoning, 110002

  • The Second Affiliated Hospital of Shenyang Medical College

    Shenyang, Liaoning, 110002

  • Shengjing Hospital Of China Medical University

    Shenyang, Liaoning, 110004

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110016

  • The Fourth Affiliated Hospital Of China Medical University

    Shenyang, Liaoning, 110033

  • The People's Hospital Of Liaoning Province

    Shenyang, Liaoning, 110067

  • Fuwai Hospital Chinese Academy Of Medical Sciences, Shenzhen

    Shenzhen, Guangdong, 518057

  • The First Hospital Of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The Second Hospital Of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei, 050030

  • Bethune International Peace Hospital

    Shijiazhuang, Hebei, 050051

  • Siping First People's Hospital

    Siping, Jilin, 136001

  • The First Affiliated Hospital Of Soochow University

    Suzhou, Jiangsu, 215031

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality, 300170

  • Tianjin Chest Hospital, word1

    Tianjin, Tianjin Municipality, 300222

  • Tianjin Chest Hospital, word2

    Tianjin, Tianjin Municipality, 300222

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Weihai Municipal Hospital

    Weihai, Shandong, 264299

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

  • Wuhan Union Hospital China

    Wuhan, Hubei, 430022

  • Tongji Medical College Of Hust

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

  • Xinxiang Central Hospital

    Xinxiang, Henan, 453099

  • Xuzhou Cancer Hospital

    Xuzhou, Jiangsu, 221005

  • The Second Affiliated Hospital Of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

  • Yingkou Central Hospital, word1

    Yingkou, Liaoning, 115003

  • Yingkou Central Hospital, word2

    Yingkou, Liaoning, 115003

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044099

  • The First Affiliated Hospital Of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 451460

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong, 528403

Other trials in China

About this study

Official title: Extended Antiplatelet Therapy With Clopidogrel Alone Versus Clopidogrel Plus Aspirin After Completion of 9- to 12-month Dual Antiplatelet Therapy for ACS Patients With Both High Bleeding and Ischemic Risk.

Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary.

Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.

Read the detailed description

Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary. For patients with high risk of both ischemic and hemorrhage, despite prolonged use of DAPT may bring antithrombotic benefit, it may also increase the risk of bleeding. There is an urgent need for specific guiding on intensive antiplatelet therapy in this population of patients to reduce the risk of ischemia and to avoid the risk of bleeding.

Previous studies have shown that, after 12 months of DAPT treatment, continuation of clopidogrel monotherapy may further reduce the risk of ischemia and bleeding compared with aspirin. Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.

Being tested
Clopidogrel, Clopidogrel+aspirin
Medical subject headings
Hemorrhage

What participants receive

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

  • ClopidogrelDrug

    Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)

  • Clopidogrel+aspirinDrug

    Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)

Study groups in NCT03431142
Study groupRoleWhat they receive
Clopidogrel monotherapyExperimentalOn the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
Receives: Drug: Clopidogrel
Clopidogrel plus aspirinActive comparatorOn the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.
Receives: Drug: Clopidogrel+aspirin

What is being measured

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

  1. Clinical relevant bleeding events

    defined as BARC type 2-5 bleeding events

    Measured: During 9-month follow up

Secondary outcomes (2)

  1. All bleeding events

    defined all BARC type 1-5 bleeding events

    Measured: During 9-month follow up

  2. Major adverse cardiovascular and cerebrovascular events(MACCE)

    defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization

    Measured: During 9-month follow up

Timeline

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

  1. First posted13 Feb 2018
  2. Study start12 Feb 2018
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03431142
Sponsor's protocol ID
CLOPIL08732
Acronym
OPT-BIRISK
Status last verified
Aug 2025
First submitted
7 Feb 2018
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Jing Q, Wang B, Wang X, Li J, Qiao S, Chen S, Angiolillo DJ, Han Y. Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial. Am Heart J. 2020 Oct;228:1-7. doi: 10.1016/j.ahj.2020.07.005. Epub 2020 Jul 9.

    PubMed 32739652

  • Li Y, Li J, Wang B, Jing Q, Zeng Y, Hou A, Wang Z, Liu A, Zhang J, Zhang Y, Zhang P, Jiang D, Liu B, Fan J, Zhang J, Li L, Su G, Yang M, Jiang W, Qu P, Zeng H, Li L, Qiu M, Ru L, Chen S, Zhou Y, Qiao S, Stone GW, Angiolillo DJ, Han Y; OPT-BIRISK Investigators. Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk: The OPT-BIRISK Randomized Clinical Trial. JAMA Cardiol. 2024 Jun 1;9(6):523-531. doi: 10.1001/jamacardio.2024.0534.

    PubMed 38630489

  • Zhang D, Li Y, Qiu M, Zhou Y, Chen S, Pei H, Liu J, Xu B, Han Y, Stone GW. Clopidogrel Versus Dual-Antiplatelet Therapy for Long-Term Maintenance After Coronary Stenting in Ischemic and Bleeding Birisk Patients With Acute Coronary Syndromes and Diabetes: A Prespecified Subgroup Analysis of the OPT-BIRISK Trial. J Am Heart Assoc. 2026 Aug 20:e049178. doi: 10.1161/JAHA.126.049178. Online ahead of print.

    PubMed 42622213

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel and Clopidogrel+aspirin in people with Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage, run by Shenyang Northern Hospital at 103 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 23 inclusion and 10 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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 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. 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?

Clinical relevant bleeding events (time frame: During 9-month follow up). 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 NCT03431142, which also lists 3 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 21 Aug 2025.

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