Status:

UNKNOWN

Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI

Lead Sponsor:

Fujian Medical University

Conditions:

Acute Coronary Syndrome

Percutaneous Coronary Intervention

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The study is to evaluate the effect of optimized 12-month step-down antiplatelet therapy (APT) compared with standard 12-month dual antiplatelet therapy in clinical net adverse events, cardiovascular ...

Detailed 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 antipla...

Eligibility Criteria

Inclusion

  • Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
  • Enrollment into the study will require meeting at least one of these clinical syndromes.
  • Unstable angina
  • Non-ST elevation myocardial infarction (NSTEMI)
  • ST elevation MI (STEMI)
  • Non predominant coronary artery disease, it is defined as: exclusion of left main artery disease or left main artery bifurcated disease or ostial left anterior descending disease by coronary angiography imaging, and other high-risk vascular diseases considered by surgeons
  • Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion

  • Complications during stenting for coronary artery disease
  • Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula
  • Any planned surgery within 6 months
  • any reason why any antiplatelet therapy might need to be discontinued within 12 months
  • Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 15ml/min/1.73m\^2
  • Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants)
  • Platelet count \< 100,000 mm\^3
  • Contraindication to aspirin
  • Contraindication to ticagrelor
  • Liver cirrhosis
  • Women of child-bearing potential
  • Life expectancy \< 1 year
  • Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)

Key Trial Info

Start Date :

April 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2023

Estimated Enrollment :

2020 Patients enrolled

Trial Details

Trial ID

NCT04338919

Start Date

April 14 2020

End Date

April 1 2023

Last Update

May 13 2020

Active Locations (1)

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1

Department of Cardiology, Union Hospital, Fujian Medical University

Fuzhou, Fujian, China, 350001