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

Not Applicable

• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention
• Interventions: Procedure: Percutaneous coronary intervention; Drug: Ticagrelor plus aspirin

• Registration Number: NCT04338919
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study First Submitted: 2020-03-28
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-08
• Study Start: 2020-04-14
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13
• Primary Completion: 2021-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2020

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-APT group	Ticagrelor plus aspirin	ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months
O-APT group	Percutaneous coronary intervention	Ticagrelor 90 mg twice daily plus aspirin 100mg once daily in the first month, Ticagrelor 90mg bid between the second and the sixth months Ticagrelor 45mg bid between the seventh and the twelfth months
S-APT group	Percutaneous coronary intervention	ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months
O-APT group	Ticagrelor plus aspirin	Ticagrelor 90 mg twice daily plus aspirin 100mg once daily in the first month, Ticagrelor 90mg bid between the second and the sixth months Ticagrelor 45mg bid between the seventh and the twelfth months

Primary Outcome Measures

Name	Time	Method
Major cardiovascular and cerebrovascular adverse events	Up to 12 months after PCI	Participants with death from cardiovascular causes, non-fatal myocardial infarction, stent thrombosis,Ischemia driven coronary revascularization and ischemic stroke.Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Major bleeding events	Up to 12 months after PCI	Plato massive hemorrhage events, including fatal hemorrhage, intracranial hemorrhage, pericardial hemorrhage with pericardial tamponade, hypovolemic shock or severe hypotension caused by hemorrhage, requiring pressor or surgery, hemoglobin level dropping 5.0 g or more per deciliter, or at least requiring blood transfusion. Events were adjudicated by an endpoint committee.; BARC type 2, 3 or 5 bleeding. Events were adjudicated by an endpoint committee.
The net adverse clinical events	Up to 12 months after PCI	included major adverse cardiovascular and cerebrovascular events or major bleeding events.

Secondary Outcome Measures

Name	Time	Method
Participants with myocardial infarction (MI) event.	Up to 36 months after PCI	Number of participants with MI event. Events were adjudicated by an endpoint committee.
Participants with death from cardiovascular causes.	Up to 36 months after PCI	Number of participants with death from cardiovascular causes. Events were adjudicated by an endpoint committee.
Participants with death from any cause.	Up to 36 months after PCI	Number of participants with death from any cause. Events were adjudicated by an endpoint committee.
PLATO-defined any bleeding event.	Up to 36 months after PCI	Number of participants with any other bleeding events (minor bleeding or minimal bleeding) as defined by the PLATO. Events were adjudicated by an endpoint committee.

Trial Locations

Locations (1)

Department of Cardiology, Union Hospital, Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China