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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338919
• Other study ID #: Optimized-APT
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2020
• Source: Fujian Medical University
• Contact: Chen Lianglong, MD, PhD
• Phone: +86-13950303022
• Email: lianglongchen[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2020
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Procedure:
• Percutaneous coronary intervention
PCI with stent implantation

Drug:
• Ticagrelor plus aspirin
Ticagrelor plus aspirin

Locations

Country	Name	City	State
China	Department of Cardiology, Union Hospital, Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	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
Other	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
Primary	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
Primary	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
Primary	The net adverse clinical events	included major adverse cardiovascular and cerebrovascular events or major bleeding events.	Up to 12 months after PCI
Secondary	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
Secondary	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
Secondary	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
Secondary	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