Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Coronary Syndrome
  • Percutaneous Coronary Intervention
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

This is a prospective, multi- center, randomized, parallel-group trial designed to evaluate the effect of optimized 12-month step-down antiplatelet therapy compared with standard 12-month dual antiplatelet therapy in clinical net adverse clinical events, cardiovascular and cerebrovascular adverse ev...

This is a prospective, multi- center, randomized, parallel-group trial designed to evaluate the effect of optimized 12-month step-down antiplatelet therapy compared with standard 12-month dual antiplatelet therapy in clinical net adverse clinical events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome who are not the main coronary artery disease.2020 subjects will be enrolled. After PCI,eligible patients will be randomly assigned in a 1:1 ratio to either the optimized antiplatelet therapy group?O-APT?or the standard antiplatelet therapy group?S-APT?. The primary efficacy end points are clinical net adverse clinical events ,or the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, ischemia driven coronary revascularization and stroke at 12 months. The primary safety end point is the incidence of PLATO major bleeding or Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months.

Tracking Information

NCT #
NCT04338919
Collaborators
Not Provided
Investigators
Principal Investigator: Chen Lianglong, MD, PhD Fujian Medical University