Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial (OPT-BIRISK)

August 17, 2025 updated by: Han Yaling, Shenyang Northern Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7758

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100730
        • Beijing Hospital
      • Beijing, China, 100037
        • Fuwai Hospital Chinese Academy of Medical Sciences
      • Beijing, China, 100020
        • Beijing Chao-Yang Hospital,Capital Medical University
      • Beijing, China, 101199
        • Beijing Luhe Hospital, Capital Medical University
      • Beijing, China, 100029
        • Beijing Anzhen Hospital,Capital Medical University， word1
      • Beijing, China, 100048
        • The Sixth Medical Center of PLA General Hospital
      • Beijing, China, 100730
        • Beijing tongren hospital,CMU
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
    • Beijing
      • Beijing, Beijing, China, 102218
        • Beijing Tsinghua Changgung Hospital
      • Beijing, Beijing, China, 102206
        • Peking University International Hospital
      • Beijing, Beijing, China, 100010
        • The Seventh Medical Center of PLA General Hospital
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital,Capital Medical University, word2
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital,Capital Medical University, word3
      • Beijing, Beijing, China, 100088
        • PLA Rocket Force Characteristic Medical Center
    • Chongqing
      • Chongqing, Chongqing, China, 401331
        • University-Town Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China, 400037
        • Xinqiao Hospital Army Medical University
      • Chongqing, Chongqing, China, 400042
        • Department of Cardiology, Daping Hospital, The Third Military Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital,Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510235
        • Guangzhou Red Cross Hospital
      • Meizhou, Guangdong, China, 514031
        • Meizhou People's Hospital
      • Shenzhen, Guangdong, China, 518057
        • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan City People's Hospital
    • Guangxi
      • Liuzhou, Guangxi, China, 545007
        • Liuzhou Worker's Hospital
    • Hebei
      • Cangzhou, Hebei, China, 061011
        • Cangzhou Central Hospital
      • ShiJiazhuang, Hebei, China, 050030
        • Shijiazhuang People's Hospital
      • Shijia Zhuang, Hebei, China, 050051
        • Bethune International Peace Hospital
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University
    • Henan
      • Xinxiang, Henan, China, 453099
        • Xinxiang Central Hospital
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 451460
        • Fuwai Central China Cardiovascular Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Asia Heart Hospital
      • Wuhan, Hubei, China, 430030
        • Tongji Medical College of HUST
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital China
    • Hunan
      • Changsha, Hunan, China, 410005
        • People's Hospital of Hunan Province
      • Changsha, Hunan, China, 410205
        • The Third XIANGYA Hospital of Central South University
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010017
        • Inner Mongolia People's Hospital
      • HulunBuir, Inner Mongolia, China, 021008
        • Hulunbuir People's Hospital
      • Hulunbuir, Inner Mongolia, China, 022150
        • Inner Mongolia Forestry General Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, China, 210016
        • Nanjing Jinling Hospital
      • Suzhou, Jiangsu, China, 215031
        • The First Affiliated Hospital of Soochow University
      • Xuzhou, Jiangsu, China, 221005
        • Xuzhou Cancer Hospital
      • Xuzhou, Jiangsu, China, 221006
        • The Second Affiliated Hospital of Xuzhou Medical University
    • Jilin
      • Changchun, Jilin, China, 130033
        • China-Japan Union Hospital of Jilin University
      • Changchun, Jilin, China, 130041
        • The Second Hospital of Jilin University
      • Changchun, Jilin, China, 130021
        • The First Bethune Hospital of Jilin University
      • Jilin, Jilin, China, 132011
        • Jilin Central General Hospital
      • Jilin, Jilin, China, 132021
        • Jilin City Hospital Of Chemical Industry, word1
      • Jilin, Jilin, China, 132021
        • Jilin City Hospital Of Chemical Industry, word2
      • Meihekou, Jilin, China, 135099
        • Meihekou Central Hospital
      • Siping, Jilin, China, 136001
        • Siping First People's Hospital
    • Liaoning
      • Anshan, Liaoning, China, 114008
        • Anshan Center Hospital
      • Benxi, Liaoning, China, 117099
        • Benxi Central Hospital
      • Dalian, Liaoning, China, 116023
        • The Second Hospital of Dalian Medical University
      • Dalian, Liaoning, China, 116011
        • The First Affiliated Hospital of Dalian Medical University
      • Dalian, Liaoning, China, 116100
        • Dalian Friendship Hospital
      • Dandong, Liaoning, China, 118002
        • Dandong Central Hospital
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command
      • Shenyang, Liaoning, China, 110002
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110067
        • The People's Hospital of Liaoning Province
      • Shenyang, Liaoning, China, 110000
        • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Shenyang, Liaoning, China, 110002
        • The Second Affiliated Hospital of Shenyang Medical College
      • Shenyang, Liaoning, China, 110033
        • The Fourth Affiliated Hospital of China Medical University
      • Yingkou, Liaoning, China, 115003
        • Yingkou Central Hospital, word1
      • Yingkou, Liaoning, China, 115003
        • Yingkou Central Hospital, word2
    • Neimonggol
      • Baotou, Neimonggol, China, 014017
        • The First Affiliated Hospital of Baotou Medical College
      • Baotou, Neimonggol, China, 014040
        • Baotou City Central Hospital
      • Hohhot, Neimonggol, China, 010017
        • Inner Mongolia People's Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, China, 250063
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China, 250031
        • The General Hospital Of Jinan Military Command
      • Jinan, Shandong, China, 250013
        • Central Hospital Affiliated to Shandong First Medical University
      • Weihai, Shandong, China, 264299
        • Weihai Municipal Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital
      • Shanghai, Shanghai, China, 200032
        • Zhongshan hospital
      • Shanghai, Shanghai, China, 200020
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital,Fudan University
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
      • Shanghai, Shanghai, China, 200235
        • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
    • Shanxi
      • Linfen, Shanxi, China, 041099
        • Linfen Central Hospital
      • Taiyuan, Shanxi, China, 030024
        • Shanxi Cardiovascular Hospital
      • Yuncheng, Shanxi, China, 044099
        • Yuncheng Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital, word 1
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital, word 2
      • Chengdu, Sichuan, China, 610083
        • The General Hospital of Western Theater Command PLA
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • General Hospital of Tianjin Medical University
      • Tianjin, Tianjin, China, 300170
        • Tianjin Third Central Hospital
      • Tianjin, Tianjin, China, 300222
        • Tianjin Chest Hospital, word1
      • Tianjin, Tianjin, China, 300222
        • Tianjin Chest Hospital, word2
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830011
        • The First Affiliated Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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
  • Unable or unwilling to provide informed consent
  • Women with childbearing potential
  • Platelet count <100000/mm3
  • Subjects undergoing warfarin or similar anticoagulant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Clopidogrel monotherapy
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
Drug: Clopidogrel
Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
Active Comparator: Clopidogrel plus aspirin
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.
Drug: Clopidogrel+aspirin
Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical relevant bleeding events
Time Frame: During 9-month follow up
defined as BARC type 2-5 bleeding events
During 9-month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All bleeding events
Time Frame: During 9-month follow up
defined all BARC type 1-5 bleeding events
During 9-month follow up
Major adverse cardiovascular and cerebrovascular events(MACCE)
Time Frame: During 9-month follow up
defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
During 9-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenyang Northern Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yaling Han, MD, The General Hospital of Northern Theater Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLOPIL08732

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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