Acute Coronary Syndrome (ACS)NCT07354828
Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy
An observational study of Acute Coronary Syndrome (ACS) and High Bleeding Risk (HBR), run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype. Percutaneous Coronary Intervention (PCI) plus stent implantation is the first-line treatment for ACS, and post-PCI Dual Antiplatelet Therapy (DAPT, aspirin +… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR), Coronary Artery Disease (CAD)
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 30 Jun 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be selected from inpatients admitted to multiple nationwide medical centers (including prefecture/county-level hospitals and provincial/national key hospitals) who are clinically diagnosed with Acute Coronary Syndrome (ACS) and undergo Percutaneous Coronary Intervention (PCI) with Drug-Eluting Stent (DES) implantation during hospitalization. The source population consists of ACS patients who meet the clinical diagnostic criteria, require PCI treatment, and are potentially at high bleeding risk (may fulfill ARC-HBR criteria). Patients with clear contraindications to Dual Antiplatelet Therapy (DAPT), inability to complete follow-up, or other conditions that make them unsuitable for the study are excluded from the source population.
Who may be able to join
- Aged ≥ 18 years
- Clinically diagnosed with ACS and received implantation of at least one drug-eluting stent (DES)
- Meets 1 major criterion or 2 minor criteria of the ARC-HBR high-bleeding-risk definition
- Able to complete the OPT-CAD score calculation
- Judged by the investigator to tolerate DAPT for at least 12 months
- Signed the informed consent form
Who cannot join
- Allergy to study medications such as aspirin, clopidogrel, or ticagrelor
- Occurrence of major ischemic or bleeding events during the current hospitalization
- Presence of other severe diseases with a life expectancy of less than one year
- Pregnancy, or women of childbearing potential who plan to become pregnant within one year
- Current participation in another clinical study and still within its observation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110000
About this study
Official title: Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy: Establishment of a Quality Control Standard System for Coronary Revascularization in Coronary Heart Disease Based on Dual Antiplatelet Therapy (DAPT)
Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype. Percutaneous Coronary Intervention (PCI) plus stent implantation is the first-line treatment for ACS, and post-PCI Dual Antiplatelet Therapy (DAPT, aspirin + P2Y₁₂ inhibitor) is core for thrombosis prevention but increases bleeding risk. Approximately 40% of ACS patients are classified as High Bleeding Risk (HBR). China lacks a unified DAPT quality control system, and the predictive value of the OPT-CAD ischemic risk score for this population remains unvalidated. This study aims to: 1) Evaluate the feasibility and influencing factors of the DAPT quality control system in HBR ACS patients post-PCI; 2) Verify the accuracy of the OPT-CAD score in predicting ischemic risk, providing evidence for personalized treatment.
Eligibility Criteria Inclusion Criteria Aged ≥18 years; Diagnosed with ACS and implanted with at least one drug-eluting stent (DES) during PCI; Meets ARC-HBR (Academic Research Consortium for High Bleeding Risk) HBR definition (1 major criterion or 2 minor criteria); Able to complete OPT-CAD scoring; Tolerates 12-month DAPT (physician assessment); Signs informed consent. Exclusion Criteria Allergy to aspirin, clopidogrel, ticagrelor, or other study-related antiplatelet drugs; Severe ischemia or major bleeding during current hospitalization; Terminal illness with life expectancy <1 year; Pregnant or planning pregnancy within 1 year; Enrolled in other ongoing clinical studies. Study Process
Read more
This is a multi-center prospective cohort study (we will follow eligible patients over 12 months to collect real-world data without changing their standard care) recruiting 3,500 participants nationwide. Post-enrollment:
Receive 6-12 months of standard DAPT (regimen determined by your physician); Follow-ups at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) post-PCI (via phone or outpatient visit) to collect medication adherence, bleeding/ischemic events, and clinical outcomes; Confidential data collection via a secure Electronic Data Capture (EDC) system. Study Endpoints Primary Endpoints Feasibility of the DAPT quality control system, inter-hospital differences in DAPT use, 6-12 month DAPT completion rate, and impact of DAPT interruption on patient outcomes; Accuracy of the OPT-CAD score in predicting ischemic risk for HBR patients. Secondary Endpoints 12-month bleeding event rates (BARC 1-5 types, including minor bleeding like puncture site bleeding and major bleeding like intracranial hemorrhage); 12-month ischemic event rates (including target lesion failure-cardiac death, target vessel-related myocardial infarction, or target lesion revascularization-all-cause death, ischemic stroke, definite stent thrombosis, etc.); DAPT interruption rate, P2Y₁₂ inhibitor discontinuation rate (≥1 week), and aspirin discontinuation rate (≥1 week).
Key Information for Participants Voluntary participation: You may withdraw anytime without penalty or loss of medical benefits; Confidential data protection: Personal information will be anonymized with a unique study ID; Free study-related assessments and follow-ups; Prompt medical care will be provided for any adverse events. For inquiries, contact the study team at the participating hospital.
Read the detailed description
This study is a prospective, multicenter, observational registry cohort study designed to evaluate real-world dual antiplatelet therapy (DAPT) management in high-bleeding-risk patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
Eligible patients undergoing PCI will be screened against the study inclusion and exclusion criteria. Patients who meet eligibility requirements will be invited to participate, provide informed consent, and be assigned a unique study identification number. Study participation will not alter routine clinical care, and all treatment decisions, including DAPT regimen selection and duration, will be determined by the treating physician in accordance with standard clinical practice.
A total of approximately 3,500 evaluable patients are planned to be enrolled across multiple centers nationwide, including prefecture-level/district/county hospitals and provincial or national key hospitals. Enrollment will reflect real-world clinical practice, with no more than a predefined proportion of patients enrolled at any single site.
Clinical data will be collected prospectively at baseline and during routine follow-up at approximately 1, 3, 6, and 12 months following PCI. Collected information will include patient characteristics, PCI-related data, DAPT treatment patterns, and clinical outcomes.
The registry is designed to characterize real-world application of a DAPT quality control indicator system and to evaluate the prognostic performance of the OPT-CAD score in high-bleeding-risk ACS patients. Findings from this study are expected to provide real-world evidence to support standardized DAPT quality control and personalized antiplatelet therapy in this high-risk population.
- Keywords
- Dual Antiplatelet Therapy (DAPT), Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR), Percutaneous Coronary Intervention (PCI), OPT-CAD Score, Quality Control Indicators, Coronary Revascularization, Prospective Cohort Study, Real-World Research, Bleeding Events, Ischemic Events, Medication Adherence, Post-PCI Prognosis
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low Ischemic Risk (OPT-CAD < 90) | This group includes patients with high bleeding risk (meeting ARC-HBR criteria) who are diagnosed with Acute Coronary Syndrome (ACS) and have undergone Percutaneous Coronary Intervention (PCI) with at least one Drug-Eluting Stent (DES) implantation. All participants have an OPT-CAD score < 90, indicating low ischemic risk. They receive routine Dual Antiplatelet Therapy (DAPT) for 6-12 months as per clinical guidelines (specific regimens determined by attending physicians). During the 12-month follow-up, data on DAPT adherence, discontinuation reasons, and clinical outcomes (bleeding/ischemic events, mortality) will be collected to compare with the moderate/high ischemic risk group. | |
| Moderate/High Ischemic Risk (OPT-CAD ≥ 90) | This group comprises patients who meet the same baseline criteria as Group 1: high bleeding risk (ARC-HBR positive), ACS diagnosis, PCI with DES implantation, and ability to tolerate 12-month DAPT. The key distinction is an OPT-CAD score ≥ 90, classifying them as moderate/high ischemic risk. They also receive standard 6-12 month DAPT (regimens decided by clinicians). Follow-up procedures and data collection are identical to Group 1, aiming to verify the predictive value of the OPT-CAD score by comparing clinical outcomes between the two groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall composite of 11 performance measures for DAPT-based Quality Control Standard System for Coronary Artery Disease Revascularization.
The proportion of ACS patients scheduled for stent implantation during PCI who undergo risk stratification; The proportion of ACS patients undergoing PCI who initiate DAPT during the procedure; The proportion of ACS patients who maintain DAPT for at least 12 months after PCI; In patients at "high bleeding risk", the proportion of patients whose DAPT regimens are adjusted according to risk; The proportion of patients with implanted BRS who maintain DAPT for more than 12 months; The proportion of patients receiving alternative DAPT regimens due to drug intolerance or allergy; The proportion of implementation of optimized regimens combining anticoagulation with DAPT; The proportion of DAPT adjustment following bleeding events; Incidence of ischemic events: cardiac death, ischemic stroke, definite stent thrombosis, TVR, and TLF; Incidence of bleeding events: BARC Types 3/5 bleeding; The proportion of patients adherent to standardized DAPT.
Measured: 12 months
Accuracy of the OPT-CAD score in predicting ischemia risk in high-bleeding-risk patients.
The OPT-CAD score (Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease) is an ischemic risk scoring system developed based on the Chinese OPT-CAD registry study (107 centers, 14,032 patients). It is specifically used to predict long-term ischemic events and all-cause mortality in Chinese patients with coronary artery disease, especially those with acute coronary syndrome (ACS). OPT-CAD score ranges from 0 to 257 points in total. Patients are divided into three risk levels based on their total scores, corresponding to different incidences of ischemic events:Low risk 0-90 points ;Medium risk 91-150 points High risk ≥151 points.
Measured: 12 months
Secondary outcomes (8)
Incidence of first BARC 3/5 bleeding within 12 months;
Incidence rate of major bleeding events (Bleeding Academic Research Consortium (BARC)[1] defined Type 3 and Type 5 bleeding) [1]Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. PMID: 21670242.
Measured: 12 months
Incidence of first BARC 2/3/5 bleeding within 12 months
Incidence rate of bleeding events (Bleeding Academic Research Consortium (BARC)[1] defined Type2, Type 3 and Type 5 bleeding, including puncture site bleeding, gastrointestinal bleeding, and intracranial hemorrhage.)[1]Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. PMID: 21670242.
Measured: 12 months
Incidence of first BARC 1/2/3/5 bleeding within 12 months
Incidence rate of bleeding events (Bleeding Academic Research Consortium (BARC)[1] defined Type1, Type2, Type 3 and Type 5 bleeding, including puncture site bleeding, gastrointestinal bleeding, and intracranial hemorrhage.)[1]Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. PMID: 21670242.
Measured: 12 months
Incidence of target lesion failure (TLF) within 12 months
defined as cardiac death, target vessel myocardial infarction, and target lesion revascularization
Measured: 12 months
Incidence of different types of ischemic events within 12 months
- All-cause death
- Cardiac death
- Ischemic stroke
- Definite stent thrombosis
- Target vessel revascularization
Measured: 12 months
Discontinuation rate of continuous dual antiplatelet therapy;
Measured: 12 months
Discontinuation rate of P2Y12 inhibitor
discontinuation for ≥1 week
Measured: 12 months
Discontinuation rate of aspirin
discontinuation for ≥1 week
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start30 Dec 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354828
- Sponsor's protocol ID
- 2025ZD0546702
- Status last verified
- Sep 2025
- First submitted
- 30 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1.Li PX.Long-term prognosis and influencing factors of high bleeding risk ACS patients after PCI [Master's Thesis]; 2023.2.Yin P,Qi JL,Liu YN,et al.China's disease burden study report 2005-2017.Chinese Circulation Journal 2019; 34(12):1145-1154.3.Liu MB,He XY,Yang XH,et al. Summary of "China Cardiovascular Health and Disease Report 2023"(Epidemiology of cardiovascular diseases and interventional diagnosis and treatment status). Chinese Journal of Interventional Cardiology 2024;32(10): 541-550.4.Tan MQ,Yin CE,Wang FJ.Interpretation of the 2018 updated universal definition of myocardial infarction.Journal of Practical Electrocardiology 2018; 27(06):381-385.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy: Establishment of a Quality Control Standard System for Coronary Revascularization in Coronary Heart Disease Based on Dual Antiplatelet Therapy (DAPT)
- ClinicalTrials.gov ID
- NCT07354828
- Acronym / sponsor ID
- 2025ZD0546702
- Keywords
- Dual Antiplatelet Therapy (DAPT), Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR), Percutaneous Coronary Intervention (PCI), OPT-CAD Score, Quality Control Indicators, Coronary Revascularization, Prospective Cohort Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype. Percutaneous Coronary Intervention (PCI) plus stent implantation is the first-line treatment for ACS, and post-PCI Dual Antiplatelet Therapy (DAPT, aspirin + P2Y₁₂ inhibitor) is core for thrombosis prevention but increases bleeding risk. Approximately 40% of ACS patients are classified as High Bleeding Risk (HBR). China lacks a unified DAPT quality control system, and the predictive value of the OPT-CAD ischemic risk score for this population remains unvalidated. This study aims to: 1) Evaluate the feasibility and influencing factors of the DAPT quality control system in HBR ACS patients post-PCI; 2) Verify the accuracy of the OPT-CAD score in predicting ischemic risk, providing evidence for personalized treatment.
Eligibility Criteria Inclusion Criteria Aged ≥18 years; Diagnosed with ACS and implanted with at least one drug-eluting stent (DES) during PCI; Meets ARC-HBR (Academic Research Consortium for High Bleeding Risk) HBR definition (1 major criterion or 2 minor criteria); Able to complete OPT-CAD scoring; Tolerates 12-month DAPT (physician assessment); Signs informed consent. Exclusion Criteria Allergy to aspirin, clopidogrel, ticagrelor, or other study-related antiplatelet drugs; Severe ischemia or major bleeding during current hospitalization; Terminal illness with life expectancy <1 year; Pregnant or planning pregnancy within 1 year; Enrolled in other ongoing clinical studies. Study Process
This is a multi-center prospective cohort study (we will follow eligible patients over 12 months to collect real-world data without changing their standard care) recruiting 3,500 participants nationwide. Post-enrollment:
Receive 6-12 months of standard DAPT (regimen determined by your physician); Follow-ups at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) post-PCI (via phone or outpatient visit) to collect medication adherence, bleeding/ischemic events, and clinical outcomes; Confidential data collection via a secure Electronic Data Capture (EDC) system. Study Endpoints Primary Endpoints Feasibility of the DAPT quality control system, inter-hospital differences in DAPT use, 6-12 month DAPT completion rate, and impact of DAPT interruption on patient outcomes; Accuracy of the OPT-CAD score in predicting ischemic risk for HBR patients. Secondary Endpoints 12-month bleeding event rates (BARC 1-5 types, including minor bleeding like puncture site bleeding and major bleeding like intracranial hemorrhage); 12-month ischemic event rates (including target lesion failure-cardiac death, target vessel-related myocardial infarction, or target lesion revascularization-all-cause death, ischemic stroke, definite stent thrombosis, etc.); DAPT interruption rate, P2Y₁₂ inhibitor discontinuation rate (≥1 week), and aspirin discontinuation rate (≥1 week).
Key Information for Participants Voluntary participation: You may withdraw anytime without penalty or loss of medical benefits; Confidential data protection: Personal information will be anonymized with a unique study ID; Free study-related assessments and follow-ups; Prompt medical care will be provided for any adverse events. For inquiries, contact the study team at the participating hospital.
Detailed description
This study is a prospective, multicenter, observational registry cohort study designed to evaluate real-world dual antiplatelet therapy (DAPT) management in high-bleeding-risk patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
Eligible patients undergoing PCI will be screened against the study inclusion and exclusion criteria. Patients who meet eligibility requirements will be invited to participate, provide informed consent, and be assigned a unique study identification number. Study participation will not alter routine clinical care, and all treatment decisions, including DAPT regimen selection and duration, will be determined by the treating physician in accordance with standard clinical practice.
A total of approximately 3,500 evaluable patients are planned to be enrolled across multiple centers nationwide, including prefecture-level/district/county hospitals and provincial or national key hospitals. Enrollment will reflect real-world clinical practice, with no more than a predefined proportion of patients enrolled at any single site.
Clinical data will be collected prospectively at baseline and during routine follow-up at approximately 1, 3, 6, and 12 months following PCI. Collected information will include patient characteristics, PCI-related data, DAPT treatment patterns, and clinical outcomes.
The registry is designed to characterize real-world application of a DAPT quality control indicator system and to evaluate the prognostic performance of the OPT-CAD score in high-bleeding-risk ACS patients. Findings from this study are expected to provide real-world evidence to support standardized DAPT quality control and personalized antiplatelet therapy in this high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Ischemic Risk (OPT-CAD < 90) | – | –This group includes patients with high bleeding risk (meeting ARC-HBR criteria) who are diagnosed with Acute Coronary Syndrome (ACS) and have undergone Percutaneous Coronary Intervention (PCI) with at least one Drug-Eluting Stent (DES) implantation. All participants have an OPT-CAD score < 90, indicating low ischemic risk. They receive routine Dual Antiplatelet Therapy (DAPT) for 6-12 months as per clinical guidelines (specific regimens determined by attending physicians). During the 12-month follow-up, data on DAPT adherence, discontinuation reasons, and clinical outcomes (bleeding/ischemic events, mortality) will be collected to compare with the moderate/high ischemic risk group. |
| Moderate/High Ischemic Risk (OPT-CAD ≥ 90) | – | –This group comprises patients who meet the same baseline criteria as Group 1: high bleeding risk (ARC-HBR positive), ACS diagnosis, PCI with DES implantation, and ability to tolerate 12-month DAPT. The key distinction is an OPT-CAD score ≥ 90, classifying them as moderate/high ischemic risk. They also receive standard 6-12 month DAPT (regimens decided by clinicians). Follow-up procedures and data collection are identical to Group 1, aiming to verify the predictive value of the OPT-CAD score by comparing clinical outcomes between the two groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from inpatients admitted to multiple nationwide medical centers (including prefecture/county-level hospitals and provincial/national key hospitals) who are clinically diagnosed with Acute Coronary Syndrome (ACS) and undergo Percutaneous Coronary Intervention (PCI) with Drug-Eluting Stent (DES) implantation during hospitalization. The source population consists of ACS patients who meet the clinical diagnostic criteria, require PCI treatment, and are potentially at high bleeding risk (may fulfill ARC-HBR criteria). Patients with clear contraindications to Dual Antiplatelet Therapy (DAPT), inability to complete follow-up, or other conditions that make them unsuitable for the study are excluded from the source population.
Key inclusion criteria (6 listed)
- Aged ≥ 18 years
- Clinically diagnosed with ACS and received implantation of at least one drug-eluting stent (DES)
- Meets 1 major criterion or 2 minor criteria of the ARC-HBR high-bleeding-risk definition
- Able to complete the OPT-CAD score calculation
- Judged by the investigator to tolerate DAPT for at least 12 months
Key exclusion criteria (5 listed)
- Allergy to study medications such as aspirin, clopidogrel, or ticagrelor
- Occurrence of major ischemic or bleeding events during the current hospitalization
- Presence of other severe diseases with a life expectancy of less than one year
- Pregnancy, or women of childbearing potential who plan to become pregnant within one year
- Current participation in another clinical study and still within its observation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall composite of 11 performance measures for DAPT-based Quality Control Standard System for Coronary Artery Disease Revascularization.
Time frame: 12 months
The proportion of ACS patients scheduled for stent implantation during PCI who undergo risk stratification; The proportion of ACS patients undergoing PCI who initiate DAPT during the procedure; The proportion of ACS patients who maintain DAPT for at least 12 months after PCI; In patients at "high bleeding risk", the proportion of patients whose DAPT regimens are adjusted according to risk; The proportion of patients with implanted BRS who maintain DAPT for more than 12 months; The proportion of patients receiving alternative DAPT regimens due to drug intolerance or allergy; The proportion of implementation of optimized regimens combining anticoagulation with DAPT; The proportion of DAPT adjustment following bleeding events; Incidence of ischemic events: cardiac death, ischemic stroke, definite stent thrombosis, TVR, and TLF; Incidence of bleeding events: BARC Types 3/5 bleeding; The proportion of patients adherent to standardized DAPT.
Accuracy of the OPT-CAD score in predicting ischemia risk in high-bleeding-risk patients.
Time frame: 12 months
The OPT-CAD score (Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease) is an ischemic risk scoring system developed based on the Chinese OPT-CAD registry study (107 centers, 14,032 patients). It is specifically used to predict long-term ischemic events and all-cause mortality in Chinese patients with coronary artery disease, especially those with acute coronary syndrome (ACS). OPT-CAD score ranges from 0 to 257 points in total. Patients are divided into three risk levels based on their total scores, corresponding to different incidences of ischemic events:Low risk 0-90 points ;Medium risk 91-150 points High risk ≥151 points.
8 secondary outcomes
Incidence of first BARC 3/5 bleeding within 12 months;
Time frame: 12 months
Incidence of first BARC 2/3/5 bleeding within 12 months
Time frame: 12 months
Incidence of first BARC 1/2/3/5 bleeding within 12 months
Time frame: 12 months
Incidence of target lesion failure (TLF) within 12 months
Time frame: 12 months
Incidence of different types of ischemic events within 12 months
Time frame: 12 months
Discontinuation rate of continuous dual antiplatelet therapy;
Time frame: 12 months
Discontinuation rate of P2Y12 inhibitor
Time frame: 12 months
Discontinuation rate of aspirin
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background1.Li PX.Long-term prognosis and influencing factors of high bleeding risk ACS patients after PCI [Master's Thesis]; 2023.2.Yin P,Qi JL,Liu YN,et al.China's disease burden study report 2005-2017.Chinese Circulation Journal 2019; 34(12):1145-1154.3.Liu MB,He XY,Yang XH,et al. Summary of "China Cardiovascular Health and Disease Report 2023"(Epidemiology of cardiovascular diseases and interventional diagnosis and treatment status). Chinese Journal of Interventional Cardiology 2024;32(10): 541-550.4.Tan MQ,Yin CE,Wang FJ.Interpretation of the 2018 updated universal definition of myocardial infarction.Journal of Practical Electrocardiology 2018; 27(06):381-385.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome (ACS) and High Bleeding Risk (HBR), run by Shenyang Northern Hospital at 1 site 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiwei Liu, Professor (024-288897260, ifoliuhw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall composite of 11 performance measures for DAPT-based Quality Control Standard System for Coronary Artery Disease Revascularization. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT07354828, which also lists 1 linked publication.
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 Jan 2026.