Clinical trial NCT04338919: Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI
Official title: A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Effect of Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Keywords: antiplatelet therapy
Non-predominant coronary artery disease
Ticagrelor
aspirin
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 2020
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome (ACS) who are not the predominant coronary artery disease after percutaneous coronary intervention (PCI).

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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

  1. Unstable angina
  2. Non-ST elevation myocardial infarction (NSTEMI)
  3. 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 Criteria:

* 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.)

Primary outcomes:
measure: Major cardiovascular and cerebrovascular adverse events
timeFrame: Up to 12 months after PCI
measure: Major bleeding events
timeFrame: Up to 12 months after PCI
measure: The net adverse clinical events
timeFrame: Up to 12 months after PCI
Secondary outcomes:
measure: Participants with myocardial infarction (MI) event.
timeFrame: Up to 36 months after PCI
measure: Participants with death from cardiovascular causes.
timeFrame: Up to 36 months after PCI
measure: Participants with death from any cause.
timeFrame: Up to 36 months after PCI
measure: PLATO-defined any bleeding event.
timeFrame: Up to 36 months after PCI
Other outcomes:
measure: PLATO-defined any minor bleeding event
timeFrame: Up to 36 months after PCI
measure: PLATO-defined any minimal bleeding event
timeFrame: Up to 36 months after PCI
measure: Other adverse events
timeFrame: Up to 36 months after PCI
measure: Increase of serum uric acid or creatinine
timeFrame: Up to 36 months after PCI
Locations:
city: Fuzhou
country: China
facility: Department of Cardiology, Union Hospital, Fujian Medical University
state: Fujian
Study officials:
affiliation: Fujian Medical University
name: Chen Lianglong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: