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NCT Number: NCT05369442

Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Sichuan University

Sichuan, 610041, China

Location status: Recruiting

Location contact

Junyan Zhang

CONTACT

[email protected]

18848242671

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
May 11, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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