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

NCT05369442 | Recruiting

• 1 other identifier: WestChinaH-CVD-004
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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.

  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.

  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.

  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.

  1 year

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who could not be followed up (including previously reserved phone changes, etc.) to obtain MACE events.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Sichuan, Sichuan, 610041, China

RECRUITING

Related Publications (1)

• Zhang 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.

  PMID: 39867174 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, cardiology department, principal investigator

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 11, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (1)