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
1 other identifier
interventional
2,020
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedStudy Start
First participant enrolled
April 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedMay 13, 2020
May 1, 2020
12 months
March 28, 2020
May 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Participants with myocardial infarction (MI) event.
Up to 36 months after PCI
Participants with death from cardiovascular causes.
Up to 36 months after PCI
Participants with death from any cause.
Up to 36 months after PCI
PLATO-defined any bleeding event.
Up to 36 months after PCI
Other Outcomes (4)
PLATO-defined any minor bleeding event
Up to 36 months after PCI
PLATO-defined any minimal bleeding event
Up to 36 months after PCI
Other adverse events
Up to 36 months after PCI
- +1 more other outcomes
Study Arms (2)
O-APT group
EXPERIMENTALTicagrelor 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
ACTIVE COMPARATORticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months
Interventions
PCI with stent implantation
Eligibility Criteria
You may qualify if:
- 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)
- Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Union Hospital, Fujian Medical University
Fuzhou, Fujian, 350001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Lianglong, MD, PhD
Fujian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 28, 2020
First Posted
April 8, 2020
Study Start
April 14, 2020
Primary Completion
April 1, 2021
Study Completion
April 1, 2023
Last Updated
May 13, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share