Percutaneous Coronary Intervention for Myocardial Infarction at Fujian Provincial Hospital

A Registration Study on Percutaneous Coronary Intervention for Patients With Myocardial Infarction at Fujian Provincial Hospital

Research Objectives:

This clinical trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI). The primary objective is to determine whether this approach can reduce the incidence of major adverse cardiovascular events (MACE) compared to current conservative treatment.

Research Questions:

This study aims to address the following key questions:

Does standard PCI improve the clinical outcomes of MI patients (such as cardiovascular death, recurrent myocardial infarction, or revascularization due to ischemia-driven vascular reconstruction)? How safe is PCI, especially in terms of bleeding risk, surgical-related complications, or other adverse events? Does PCI have a significant impact on specific secondary endpoints (such as stent thrombosis, hospitalization for heart failure, or quality of life indicators)?

1. Inclusion Criteria:

   1. Clinical diagnosis of acute myocardial infarction.
   2. Successful direct or emergency PCI of the infarct-related artery.
   3. Ability to undergo randomization post-PCI.
   4. Ability to understand and voluntarily sign the informed consent form.

2. Exclusion Criteria:

   1. PCI failure (final TIMI flow < grade 2) or presence of untreated severe stenosis.
   2. Planned staged PCI or other cardiac surgery within 3 months.
   3. Cardiogenic shock (Killip class IV), severe structural heart disease, or contraindications to PCI trial intervention.
   4. Active bleeding or high bleeding risk.
   5. Known allergy to the trial drug or its components.
   6. ALT/AST > 3x upper limit of normal (ULN); eGFR < 30 mL/min/1.73 m².
   7. Non-cardiovascular disease with life expectancy < 1 year (e.g., active malignancy).
   8. History of hemorrhagic stroke, or any ischemic stroke/transient ischemic attack within the past 6 months.
   9. Requirement for long-term oral anticoagulation therapy.
   10. Pregnancy, lactation, or women of childbearing potential not using effective contraception.
   11. Current participation in another interventional clinical trial.
   12. Any condition that may affect trial compliance, safety assessment, or result interpretation per investigator judgment.