search
Back to results

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

Primary Purpose

Acute Coronary Syndrome, Percutaneous Coronary Intervention

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Ticagrelor plus aspirin
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring antiplatelet therapy, Non-predominant coronary artery disease, Ticagrelor, aspirin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Department of Cardiology, Union Hospital, Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

O-APT group

S-APT group

Arm Description

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

ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months

Outcomes

Primary Outcome Measures

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.
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.
The net adverse clinical events
included major adverse cardiovascular and cerebrovascular events or major bleeding events.

Secondary Outcome Measures

Participants with myocardial infarction (MI) event.
Number of participants with MI event. Events were adjudicated by an endpoint committee.
Participants with death from cardiovascular causes.
Number of participants with death from cardiovascular causes. Events were adjudicated by an endpoint committee.
Participants with death from any cause.
Number of participants with death from any cause. Events were adjudicated by an endpoint committee.
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.

Full Information

First Posted
March 28, 2020
Last Updated
May 11, 2020
Sponsor
Fujian Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04338919
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Percutaneous Coronary Intervention
Keywords
antiplatelet therapy, Non-predominant coronary artery disease, Ticagrelor, aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
O-APT group
Arm Type
Experimental
Arm Description
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
Arm Title
S-APT group
Arm Type
Active Comparator
Arm Description
ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Other Intervention Name(s)
PCI
Intervention Description
PCI with stent implantation
Intervention Type
Drug
Intervention Name(s)
Ticagrelor plus aspirin
Intervention Description
Ticagrelor plus aspirin
Primary Outcome Measure Information:
Title
Major cardiovascular and cerebrovascular adverse events
Description
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.
Time Frame
Up to 12 months after PCI
Title
Major bleeding events
Description
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.
Time Frame
Up to 12 months after PCI
Title
The net adverse clinical events
Description
included major adverse cardiovascular and cerebrovascular events or major bleeding events.
Time Frame
Up to 12 months after PCI
Secondary Outcome Measure Information:
Title
Participants with myocardial infarction (MI) event.
Description
Number of participants with MI event. Events were adjudicated by an endpoint committee.
Time Frame
Up to 36 months after PCI
Title
Participants with death from cardiovascular causes.
Description
Number of participants with death from cardiovascular causes. Events were adjudicated by an endpoint committee.
Time Frame
Up to 36 months after PCI
Title
Participants with death from any cause.
Description
Number of participants with death from any cause. Events were adjudicated by an endpoint committee.
Time Frame
Up to 36 months after PCI
Title
PLATO-defined any bleeding event.
Description
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.
Time Frame
Up to 36 months after PCI
Other Pre-specified Outcome Measures:
Title
PLATO-defined any minor bleeding event
Description
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.
Time Frame
Up to 36 months after PCI
Title
PLATO-defined any minimal bleeding event
Description
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.
Time Frame
Up to 36 months after PCI
Title
Other adverse events
Description
To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee.
Time Frame
Up to 36 months after PCI
Title
Increase of serum uric acid or creatinine
Description
To compare two intensities of ticagrelor therapy on increase of serum uric acid or creatinine.Events were adjudicated by an endpoint committee.
Time Frame
Up to 36 months after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. 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 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Lianglong, MD, PhD
Phone
+86-13950303022
Email
lianglongchen@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Mingfang, MD
Phone
+86-13365910160
Email
xieheyemingfang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Lianglong, MD, PhD
Organizational Affiliation
Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Union Hospital, Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianglong Chen, PhD, MD
Phone
(0086)139-5030-3022
Email
lianglongchen@126.com
First Name & Middle Initial & Last Name & Degree
Lianglong Chen, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs