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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention
• Intervention / Treatment: Procedure: Percutaneous coronary intervention; Drug: Ticagrelor plus aspirin

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 Type: Interventional
• Enrollment (Anticipated): 2020
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Lianglong, MD, PhD; Phone Number: +86-13950303022; Email: lianglongchen@126.com
• Study Contact Backup: Name: Ye Mingfang, MD; Phone Number: +86-13365910160; Email: xieheyemingfang@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Department of Cardiology, Union Hospital, Fujian Medical University
      • Contact: Lianglong Chen, PhD, MD; Phone Number: (0086)139-5030-3022; Email: lianglongchen@126.com
      • Principal Investigator: Lianglong Chen, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: O-APT group; 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	Procedure: Percutaneous coronary intervention; PCI with stent implantation; Other Names: PCI; Drug: Ticagrelor plus aspirin; Ticagrelor plus aspirin
ACTIVE_COMPARATOR: S-APT group; ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months	Procedure: Percutaneous coronary intervention; PCI with stent implantation; Other Names: PCI; Drug: Ticagrelor plus aspirin; Ticagrelor plus aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular and cerebrovascular adverse events	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.	Up to 12 months after PCI
Major bleeding events	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.	Up to 12 months after PCI
The net adverse clinical events	included major adverse cardiovascular and cerebrovascular events or major bleeding events.	Up to 12 months after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants with myocardial infarction (MI) event.	Number of participants with MI event. Events were adjudicated by an endpoint committee.	Up to 36 months after PCI
Participants with death from cardiovascular causes.	Number of participants with death from cardiovascular causes. Events were adjudicated by an endpoint committee.	Up to 36 months after PCI
Participants with death from any cause.	Number of participants with death from any cause. Events were adjudicated by an endpoint committee.	Up to 36 months after PCI
PLATO-defined any bleeding event.	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.	Up to 36 months after PCI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PLATO-defined any minor bleeding event	To compare two intensities of ticagrelor therapy on minor bleeding event as any bleeding requiring medical intervention but not meeting the criteria for major bleeding. Events were adjudicated by an endpoint committee.	Up to 36 months after PCI
PLATO-defined any minimal bleeding event	To compare two intensities of ticagrelor therapy on minimal bleeding event as all other bleeding(eg, bruising, bleeding gums, oozing from injection site) not requiring intervention or treatment.Events were adjudicated by an endpoint committee.	Up to 36 months after PCI
Other adverse events	To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee.	Up to 36 months after PCI
Increase of serum uric acid or creatinine	To compare two intensities of ticagrelor therapy on increase of serum uric acid or creatinine.Events were adjudicated by an endpoint committee.	Up to 36 months after PCI

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Chen Lianglong, MD, PhD, Fujian Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: March 28, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (ACTUAL): April 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Ticagrelor; aspirin; antiplatelet therapy; Non-predominant coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor
• Other Study ID Numbers: Optimized-APT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No