Coronary Artery DiseaseNCT05369442
Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol
An observational study of Coronary Artery Disease, run by West China Hospital at 1 site in China.
Trial summary
Percutaneous coronary intervention (PCI) is an important treatment strategy for patients with coronary artery disease. Combined bleeding after PCI significantly increases the risk of death in patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Aug 2029
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: People at high risk of bleeding from PCI who meet one of the primary bleeding risk criteria or two of the secondary bleeding risk criteria, according to the criteria established by the ARC-HBR.
Who may be able to join
- PCI patients >18 years of age and meeting 1 major criterion or 2 minor criteria of the ARC-HBR The ARC-HBR major criteria included:
- long-term use of oral anticoagulants;
- severe or end-stage chronic kidney disease [eGFR <30 ml/(min*1.73m2 )];
- hemoglobin <11 g/dl, spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time;
- chronic bleeding constitutional;
- cirrhosis with portal hypertension spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time;
Show all 21Show fewer
- moderate to severe baseline thrombocytopenia (platelets <100×10^9/L); chronic bleeding constitutional;
- cirrhosis with portal hypertension;
- active malignancy within the past 12 months (excluding non-melanoma skin cancer);
- previous spontaneous brain hemorrhage (at any time);
- traumatic brain hemorrhage within the past 12 months;
- within the past 6 months moderate or severe ischemic stroke within the past 6 months;
- the presence of cerebral arteriovenous malformation;
- recent major surgery or major trauma within 30 days prior to PCI;
- and major non-delayable surgery during DAPT.
- Secondary criteria included:
- age ≥75 years;
- moderate chronic kidney disease [30 ml/(min*1.73m2 ) ≤ eGFR ≤ 59 ml/(min*1.73m2 )];
- 11 g/dl ≤ hemoglobin < 13 g/dl in men and 11 g/dl ≤ hemoglobin < 12 g/dl in women; - spontaneous bleeding requiring hospitalization or blood transfusion in the past 6 months to 12 months;
- long-term use of oral NSAIDs or steroids
- Ischemic stroke of any duration not covered by the primary criteria.
Who cannot join
- Patients who were already bleeding at the time of baseline inclusion
- Patients who could not be followed up (including previously reserved phone changes, etc.) to obtain MACE events.
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, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Sichuan, Sichuan, 610041
Junyan Zhang, 18848242671, 651874354@qq.com
About this study
Percutaneous coronary intervention (PCI) is an important treatment strategy for patients with coronary artery disease. Combined bleeding after PCI significantly increases the risk of death in patients. The search for prognostic predictors and optimal antiplatelet therapy for patients with high bleeding risk (HBR) after PCI has been a hot topic in cardiovascular research. There is no accepted prognostic model or recommended antiplatelet therapy for patients with PCI-HBR. In this project, based on retrospective data extraction and prospective database building, we used artificial intelligence (AI) to analyze the adverse prognostic predictors of PCI-HBR patients, observe the types of antiplatelet drugs and duration of dual antiplatelet therapy in PCI-HBR patients, and compare the safety and feasibility of different antiplatelet regimens and treatment courses. The safety and feasibility of different antiplatelet regimens and regimens were compared.
Read the detailed description
This trail is a single center investigator-initiated prospective registry. PPP-PCI aims to observe the characteristics and prognosis of the PCI-HBR population and to explore appropriate antiplatelet therapy regimens to provide a basis for intervention guidance for patients with PCI-HBR. This project will help to further improve the existing bleeding prediction models and improve the efficiency of treating PCI-HBR patients.
Patients' baseline information is based on the latest test before PCI procedure. Basic information include age, gender, systolic blood pressure, diastolic blood pressure, body mass index, smoking status, smoking volume, positive family history of cardiovascular disease, hyperlipidemia, hypertension, diabetes, stroke history, peripheral artery disease, etc. Real-time update features include DAPT sessions, MACE event records, symptom records, sign records, test results, diagnosis, medical advice, real-time sign monitoring equipment data, ECG abnormalities, etc. Tests include a full set of lipid levels (including triglycerides, cholesterol, HDL, LDL, etc.), biochemical parameters (including creatinine, glomerular filtration rate, uric acid, etc.), hemoglobin, glucose, glycated hemoglobin, homocysteine, and lipoprotein(a) level. Imaging and functional testing data include coronary angiography images, intervention-related parameters, and target vessel lesion characteristics. The patient data is correlated with the visit intensity. The imaging images are used for deep learning to build unstructured classification models. The non-imaging data are used for machine learning to build a structured classification model. Pre-processing of the data includes image normalization, correction and normalization of irregular values, detection and removal of outliers and anomalies, interpolation and rejection of null values, removal of multicollinearity, and data normalization.
For the imaging images, a deep learning model was constructed using convolutional neural network to dichotomize the coronary vascular lesions and functional conditions contained in the coronary angiography images. For the non-imaging image data, Embedded method was used as the top-level method, and logistic regression, random forest, and gradient boosting tree were used as the bottom-level algorithms, and the key factors affecting the occurrence of MACE in the PCI-HBR population were extracted by fusing the feature weights through integrated learning. Based on the extracted key factors, a binary machine learning discriminative model was established, and SVM, XGBoost, random forest, and artificial neural network were used to complete the evaluation of multiple models, and the best model was selected as the machine learning classification model.
The deep learning model and machine learning model structures are weighted and fused to output the final results. Then the data collected by the future model is passed back to the training dataset for incremental learning to correct the model.
This trial will provide new insights and evidence on optimal antiplatelet therapy for a high bleeding risk patient cohort which is frequently encountered in real-world practice.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Death will be classified as cardiac or non-cardiac in origin. All causes of death will be considered cardiac unless a clear non-cardiac cause of death can be identified. Of these, hemorrhagic deaths will be specified.
Measured: 30 days
death
Death will be classified as cardiac or non-cardiac in origin. All causes of death will be considered cardiac unless a clear non-cardiac cause of death can be identified. Of these, hemorrhagic deaths will be specified.
Measured: 6 months
death
Death will be classified as cardiac or non-cardiac in origin. All causes of death will be considered cardiac unless a clear non-cardiac cause of death can be identified. Of these, hemorrhagic deaths will be specified.
Measured: 1 year
Myocardial infarction
Defined as recurrent signs or symptoms of myocardial ischemia lasting more than 30 minutes, with new ST-T changes or Q waves in at least two consecutive leads, or new left bundle branch block, and re-elevated cardiac enzyme levels. The following creatine kinase-myocardial band isoenzyme (CK-MB) changes will be considered meaningfully elevated: CK-MB elevation on the basis of a ≥25% decrease in peak; CK-MB elevation >50% from the previous elevation; CK-MB elevation >2 times the normal upper limit in non-coronary interventions; CK-MB elevation >2 times the normal upper limit after PCI. CK-MB is greater than 5 times the upper limit of normal after PCI.
Measured: 30 days
Myocardial infarction
Defined as recurrent signs or symptoms of myocardial ischemia lasting more than 30 minutes, with new ST-T changes or Q waves in at least two consecutive leads, or new left bundle branch block, and re-elevated cardiac enzyme levels. The following creatine kinase-myocardial band isoenzyme (CK-MB) changes will be considered meaningfully elevated: CK-MB elevation on the basis of a ≥25% decrease in peak; CK-MB elevation >50% from the previous elevation; CK-MB elevation >2 times the normal upper limit in non-coronary interventions; CK-MB elevation >2 times the normal upper limit after PCI. CK-MB is greater than 5 times the upper limit of normal after PCI.
Measured: 6 months
Myocardial infarction
Defined as recurrent signs or symptoms of myocardial ischemia lasting more than 30 minutes, with new ST-T changes or Q waves in at least two consecutive leads, or new left bundle branch block, and re-elevated cardiac enzyme levels. The following creatine kinase-myocardial band isoenzyme (CK-MB) changes will be considered meaningfully elevated: CK-MB elevation on the basis of a ≥25% decrease in peak; CK-MB elevation >50% from the previous elevation; CK-MB elevation >2 times the normal upper limit in non-coronary interventions; CK-MB elevation >2 times the normal upper limit after PCI. CK-MB is greater than 5 times the upper limit of normal after PCI.
Measured: 1 year
Ischemic stroke
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Measured: 30 days, 6 months, 1 year
Ischemic stroke
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Measured: 30 days
Ischemic stroke
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Measured: months
Ischemic stroke
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Measured: 1 year
Major bleeding
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
Measured: 30 days, 6 months, 1 year
Major bleeding
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
Measured: 30 days
Major bleeding
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
Measured: 6 months
Major bleeding
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 May 2022
- Primary completion1 May 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- 1,300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369442
- Sponsor's protocol ID
- WestChinaH-CVD-004
- Status last verified
- Jan 2026
- First submitted
- 23 Apr 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Yan T, Liu R, Li Y, Zhou M, Wang H, Li C, Rao L, Chen Z, He Y. Safety Analysis of Spironolactone Use in Patients Undergoing Percutaneous Coronary Intervention with High Bleeding Risk: A Propensity Score-Matched Study. Cardiovasc Drugs Ther. 2026 Feb;40(1):191-200. doi: 10.1007/s10557-025-07676-3. Epub 2025 Feb 5.
PubMed 39907871Zhang J, Chen Z, Liu R, Li Y, Zhao H, Li Y, Zhou M, Wang H, Li C, Rao L, He Y. Development and Validation of a Nomogram for Predicting Long-Term Net Adverse Clinical Events in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention. Rev Cardiovasc Med. 2025 Jan 17;26(1):25352. doi: 10.31083/RCM25352. eCollection 2025 Jan.
PubMed 39867174
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol
- ClinicalTrials.gov ID
- NCT05369442
- Acronym / sponsor ID
- WestChinaH-CVD-004
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 11 May 2022 (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.
Percutaneous coronary intervention (PCI) is an important treatment strategy for patients with coronary artery disease. Combined bleeding after PCI significantly increases the risk of death in patients. The search for prognostic predictors and optimal antiplatelet therapy for patients with high bleeding risk (HBR) after PCI has been a hot topic in cardiovascular research. There is no accepted prognostic model or recommended antiplatelet therapy for patients with PCI-HBR. In this project, based on retrospective data extraction and prospective database building, we used artificial intelligence (AI) to analyze the adverse prognostic predictors of PCI-HBR patients, observe the types of antiplatelet drugs and duration of dual antiplatelet therapy in PCI-HBR patients, and compare the safety and feasibility of different antiplatelet regimens and treatment courses. The safety and feasibility of different antiplatelet regimens and regimens were compared.
Detailed description
This trail is a single center investigator-initiated prospective registry. PPP-PCI aims to observe the characteristics and prognosis of the PCI-HBR population and to explore appropriate antiplatelet therapy regimens to provide a basis for intervention guidance for patients with PCI-HBR. This project will help to further improve the existing bleeding prediction models and improve the efficiency of treating PCI-HBR patients.
Patients' baseline information is based on the latest test before PCI procedure. Basic information include age, gender, systolic blood pressure, diastolic blood pressure, body mass index, smoking status, smoking volume, positive family history of cardiovascular disease, hyperlipidemia, hypertension, diabetes, stroke history, peripheral artery disease, etc. Real-time update features include DAPT sessions, MACE event records, symptom records, sign records, test results, diagnosis, medical advice, real-time sign monitoring equipment data, ECG abnormalities, etc. Tests include a full set of lipid levels (including triglycerides, cholesterol, HDL, LDL, etc.), biochemical parameters (including creatinine, glomerular filtration rate, uric acid, etc.), hemoglobin, glucose, glycated hemoglobin, homocysteine, and lipoprotein(a) level. Imaging and functional testing data include coronary angiography images, intervention-related parameters, and target vessel lesion characteristics. The patient data is correlated with the visit intensity. The imaging images are used for deep learning to build unstructured classification models. The non-imaging data are used for machine learning to build a structured classification model. Pre-processing of the data includes image normalization, correction and normalization of irregular values, detection and removal of outliers and anomalies, interpolation and rejection of null values, removal of multicollinearity, and data normalization.
For the imaging images, a deep learning model was constructed using convolutional neural network to dichotomize the coronary vascular lesions and functional conditions contained in the coronary angiography images. For the non-imaging image data, Embedded method was used as the top-level method, and logistic regression, random forest, and gradient boosting tree were used as the bottom-level algorithms, and the key factors affecting the occurrence of MACE in the PCI-HBR population were extracted by fusing the feature weights through integrated learning. Based on the extracted key factors, a binary machine learning discriminative model was established, and SVM, XGBoost, random forest, and artificial neural network were used to complete the evaluation of multiple models, and the best model was selected as the machine learning classification model.
The deep learning model and machine learning model structures are weighted and fused to output the final results. Then the data collected by the future model is passed back to the training dataset for incremental learning to correct the model.
This trial will provide new insights and evidence on optimal antiplatelet therapy for a high bleeding risk patient cohort which is frequently encountered in real-world practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- People at high risk of bleeding from PCI who meet one of the primary bleeding risk criteria or two of the secondary bleeding risk criteria, according to the criteria established by the ARC-HBR.
Key inclusion criteria (21 listed)
- PCI patients >18 years of age and meeting 1 major criterion or 2 minor criteria of the ARC-HBR The ARC-HBR major criteria included:
- long-term use of oral anticoagulants;
- severe or end-stage chronic kidney disease [eGFR <30 ml/(min*1.73m2 )];
- hemoglobin <11 g/dl, spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time;
- chronic bleeding constitutional;
Key exclusion criteria (2 listed)
- Patients who were already bleeding at the time of baseline inclusion
- Patients who could not be followed up (including previously reserved phone changes, etc.) to obtain MACE events.
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
death
Time frame: 30 days
Death will be classified as cardiac or non-cardiac in origin. All causes of death will be considered cardiac unless a clear non-cardiac cause of death can be identified. Of these, hemorrhagic deaths will be specified.
death
Time frame: 6 months
Death will be classified as cardiac or non-cardiac in origin. All causes of death will be considered cardiac unless a clear non-cardiac cause of death can be identified. Of these, hemorrhagic deaths will be specified.
death
Time frame: 1 year
Death will be classified as cardiac or non-cardiac in origin. All causes of death will be considered cardiac unless a clear non-cardiac cause of death can be identified. Of these, hemorrhagic deaths will be specified.
Myocardial infarction
Time frame: 30 days
Defined as recurrent signs or symptoms of myocardial ischemia lasting more than 30 minutes, with new ST-T changes or Q waves in at least two consecutive leads, or new left bundle branch block, and re-elevated cardiac enzyme levels. The following creatine kinase-myocardial band isoenzyme (CK-MB) changes will be considered meaningfully elevated: CK-MB elevation on the basis of a ≥25% decrease in peak; CK-MB elevation >50% from the previous elevation; CK-MB elevation >2 times the normal upper limit in non-coronary interventions; CK-MB elevation >2 times the normal upper limit after PCI. CK-MB is greater than 5 times the upper limit of normal after PCI.
Myocardial infarction
Time frame: 6 months
Defined as recurrent signs or symptoms of myocardial ischemia lasting more than 30 minutes, with new ST-T changes or Q waves in at least two consecutive leads, or new left bundle branch block, and re-elevated cardiac enzyme levels. The following creatine kinase-myocardial band isoenzyme (CK-MB) changes will be considered meaningfully elevated: CK-MB elevation on the basis of a ≥25% decrease in peak; CK-MB elevation >50% from the previous elevation; CK-MB elevation >2 times the normal upper limit in non-coronary interventions; CK-MB elevation >2 times the normal upper limit after PCI. CK-MB is greater than 5 times the upper limit of normal after PCI.
Myocardial infarction
Time frame: 1 year
Defined as recurrent signs or symptoms of myocardial ischemia lasting more than 30 minutes, with new ST-T changes or Q waves in at least two consecutive leads, or new left bundle branch block, and re-elevated cardiac enzyme levels. The following creatine kinase-myocardial band isoenzyme (CK-MB) changes will be considered meaningfully elevated: CK-MB elevation on the basis of a ≥25% decrease in peak; CK-MB elevation >50% from the previous elevation; CK-MB elevation >2 times the normal upper limit in non-coronary interventions; CK-MB elevation >2 times the normal upper limit after PCI. CK-MB is greater than 5 times the upper limit of normal after PCI.
Ischemic stroke
Time frame: 30 days, 6 months, 1 year
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Ischemic stroke
Time frame: 30 days
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Ischemic stroke
Time frame: months
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Ischemic stroke
Time frame: 1 year
Acute onset of focal or global neurological deficits lasting more than 24 hours, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) as ischemic stroke
Major bleeding
Time frame: 30 days, 6 months, 1 year
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
Major bleeding
Time frame: 30 days
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
Major bleeding
Time frame: 6 months
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
Major bleeding
Time frame: 1 year
The severity of bleeding is graded according to the BARC criteria recommended by the International Society for the Study of Hemorrhage, and the site of bleeding is described, including intracranial, gastrointestinal, respiratory (e.g., hemoptysis), urinary (e.g., hematuria), subcutaneous or mucosal, gingival, nasal, ophthalmic, and surgical puncture site related. Minor bleeds are BARC types 1 and 2, and major bleeds are BARC types 3 and 5.
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 6 Jan 2026.
- Derived from this study: PubMed 39907871Zhang J, Yan T, Liu R, Li Y, Zhou M, Wang H, Li C, Rao L, Chen Z, He Y. Safety Analysis of Spironolactone Use in Patients Undergoing Percutaneous Coronary Intervention with High Bleeding Risk: A Propensity Score-Matched Study. Cardiovasc Drugs Ther. 2026 Feb;40(1):191-200. doi: 10.1007/s10557-025-07676-3. Epub 2025 Feb 5.
- Derived from this study: PubMed 39867174Zhang J, Chen Z, Liu R, Li Y, Zhao H, Li Y, Zhou M, Wang H, Li C, Rao L, He Y. Development and Validation of a Nomogram for Predicting Long-Term Net Adverse Clinical Events in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention. Rev Cardiovasc Med. 2025 Jan 17;26(1):25352. doi: 10.31083/RCM25352. eCollection 2025 Jan.
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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 Coronary Artery Disease, run by West China 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 21 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 30 days). The study lists 14 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 NCT05369442, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.