Clinical Trials in China / NCT05369442
Recruiting
Observational
Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol
NCT05369442 · tracked via the Priya Life Science China tracker
Condition(s) studied
Coronary Artery Disease
Study 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. 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.
Eligibility
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.
Primary outcome measure(s)
- death — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| West China Hospital, Sichuan University | Sichuan | Sichuan | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05369442 on ClinicalTrials.gov ↗ ← All trials in China