Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04338919
Status:
UNKNOWN
Last Update Posted:
2020-05-13
First Post:
2020-03-28
Brief Title:
Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI
Sponsor:
Fujian Medical University
Organization:
Fujian Medical University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 disease2020 subjects will be enrolled After PCIeligible patients will be randomly assigned in a 11 ratio to either the optimized antiplatelet therapy groupO-APTor the standard antiplatelet therapy groupS-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None