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