drugset / Trial / NCT06756945

Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial

NCT06756945

Phase 4 Not yet recruiting 3612 enrolled Beijing Anzhen Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

The study aims to optimize the dual antiplatelet therapy regimen for patients with STEMI after PCI, focusing on addressing the following key technical challenges: establishing an effectiveness evaluation system for a low-dose aspirin (50mg/day) antithrombotic treatment strategy based on ticagrelor, including the formulation of a scientific non-inferiority margin, assessment criteria, and composite endpoint determination standards; constructing a strict risk assessment system for major bleeding events, including bleeding event grading based on BARC standards and a blind evaluation process by an independent endpoint event adjudication committee; and developing a quality control system for multicenter clinical research to ensure patient follow-up compliance and data reliability. By solving the above technical challenges, the study provides evidence-based medical support and technical support for optimizing the antithrombotic treatment regimen for STEMI patients after PCI.

Timeline

Start
2025-01
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 50 mg
Subject Aspirin Small molecule 100 mg
Background Ticagrelor Small molecule 90 mg