Optimal antiPlatelet Therapy for High Bleeding and Ischemic RISK Patients Trial
OPT-BIRISK
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.
1 other identifier
interventional
7,758
1 country
103
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2018
Typical duration for phase_4
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2018
CompletedStudy Start
First participant enrolled
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedAugust 21, 2025
August 1, 2025
2.9 years
February 7, 2018
August 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical relevant bleeding events
defined as BARC type 2-5 bleeding events
During 9-month follow up
Secondary Outcomes (2)
All bleeding events
During 9-month follow up
Major adverse cardiovascular and cerebrovascular events(MACCE)
During 9-month follow up
Study Arms (2)
Clopidogrel monotherapy
EXPERIMENTALOn the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
Clopidogrel plus aspirin
ACTIVE COMPARATOROn the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.
Interventions
Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)
Eligibility Criteria
You may qualify if:
- ACS patients undergoing PCI (New-Generation DES) and finishing 9-12 months of DAPT
- \~ 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
- +8 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (103)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The Seventh Medical Center of Pla General Hospital
Beijing, Beijing Municipality, 100010, China
Beijing Anzhen Hospital,Capital Medical University, word2
Beijing, Beijing Municipality, 100029, China
Beijing Anzhen Hospital,Capital Medical University, word3
Beijing, Beijing Municipality, 100029, China
PLA Rocket Force Characteristic Medical Center
Beijing, Beijing Municipality, 100088, China
Peking University International Hospital
Beijing, Beijing Municipality, 102206, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Xinqiao Hospital Army Medical University
Chongqing, Chongqing Municipality, 400037, China
Department of Cardiology, Daping Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
University-Town Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, 401331, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Guangzhou Red Cross Hospital
Guangzhou, Guangdong, 510235, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
Fuwai Hospital Chinese Academy Of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518057, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, 545007, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061011, China
The First Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, 050030, China
Bethune International Peace Hospital
Shijiazhuang, Hebei, 050051, China
Xinxiang Central Hospital
Xinxiang, Henan, 453099, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, 450052, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 451460, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Wuhan Union Hospital China
Wuhan, Hubei, 430022, China
Tongji Medical College Of Hust
Wuhan, Hubei, 430030, China
People's Hospital Of Hunan Province
Changsha, Hunan, 410005, China
The Third Xiangya Hospital Of Central South University
Changsha, Hunan, 410205, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, 010017, China
HulunBuir People's Hospital
Hulunbuir, Inner Mongolia, 021008, China
Inner Mongolia Forestry General Hospital
Hulunbuir, Inner Mongolia, 022150, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Nanjing Jinling Hospital
Nanjing, Jiangsu, 210016, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215031, China
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, 221005, China
The Second Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
The First Bethune Hospital Of Jilin University
Changchun, Jilin, 130021, China
China-Japan Union Hospital Of Jilin University
Changchun, Jilin, 130033, China
The Second Hospital Of Jilin University
Changchun, Jilin, 130041, China
Jilin Central General Hospital
Jilin, Jilin, 132011, China
Jilin City Hospital Of Chemical Industry, word1
Jilin, Jilin, 132021, China
Jilin City Hospital Of Chemical Industry, word2
Jilin, Jilin, 132021, China
Meihekou Central Hospital
Meihekou, Jilin, 135099, China
Siping First People's Hospital
Siping, Jilin, 136001, China
Anshan Center Hospital
Anshan, Liaoning, 114008, China
Benxi Central Hospital
Benxi, Liaoning, 117099, China
The First Affiliated Hospital Of Dalian Medical University
Dalian, Liaoning, 116011, China
The Second Hospital Of Dalian Medical University
Dalian, Liaoning, 116023, China
Dalian Friendship Hospital
Dalian, Liaoning, 116100, China
Dandong Central Hospital
Dandong, Liaoning, 118002, China
The First Affiliated Hospital Of Liaoning University Of Traditional Chinese Medicine
Shenyang, Liaoning, 110000, China
The First Hospital Of China Medical University
Shenyang, Liaoning, 110002, China
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, 110002, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110004, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016, China
The Fourth Affiliated Hospital Of China Medical University
Shenyang, Liaoning, 110033, China
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, 110067, China
Yingkou Central Hospital, word1
Yingkou, Liaoning, 115003, China
Yingkou Central Hospital, word2
Yingkou, Liaoning, 115003, China
The First Affiliated Hospital Of Baotou Medical College
Baotou, Neimonggol, 014017, China
Baotou City Central Hospital
Baotou, Neimonggol, 014040, China
Inner Mongolia People's Hospital
Hohhot, Neimonggol, 010017, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Central Hospital Affiliated To Shandong First Medical University
Jinan, Shandong, 250013, China
The General Hospital Of Jinan Military Command
Jinan, Shandong, 250031, China
Qilu Hospital Of Shandong University
Jinan, Shandong, 250063, China
Weihai Municipal Hospital
Weihai, Shandong, 264299, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, 200011, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200020, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Shanghai Sixth People's Hospital Affiliated To Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200235, China
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Linfen Central Hospital
Linfen, Shanxi, 041099, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital, word 1
Chengdu, Sichuan, 610072, China
Sichuan Provincial People's Hospital, word 2
Chengdu, Sichuan, 610072, China
The General Hospital Of Western Theater Command PLA
Chengdu, Sichuan, 610083, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170, China
Tianjin Chest Hospital, word1
Tianjin, Tianjin Municipality, 300222, China
Tianjin Chest Hospital, word2
Tianjin, Tianjin Municipality, 300222, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011, China
The First Affiliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310003, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, 100020, China
Beijing Anzhen Hospital,Capital Medical University， word1
Beijing, 100029, China
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, 100037, China
Peking University People's Hospital
Beijing, 100044, China
The Sixth Medical Center of PLA General Hospital
Beijing, 100048, China
Beijing Hospital
Beijing, 100730, China
Beijing Tongren Hospital,CMU
Beijing, 100730, China
Beijing Luhe Hospital, Capital Medical University
Beijing, 101199, China
Related Publications (2)
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.
PMID: 38630489BACKGROUNDLi 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.
PMID: 32739652BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaling Han, MD
The General Hospital of Northern Theater Command
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
February 7, 2018
First Posted
February 13, 2018
Study Start
February 12, 2018
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
August 21, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share