Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04240834
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2020-01-22
Brief Title:
Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome ACS at High-Risk for Ischemia After Percutaneous Coronary Intervention
Sponsor:
Fu Wai Hospital Beijing China
Organization:
Fu Wai Hospital Beijing China
Study Overview
Official Title:
Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
Not yet 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:
LD-ASPIRIN
Brief Summary:
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy DAPT in patients with acute coronary syndrome ACS at high risk for ischemic events after percutaneous coronary intervention PCI and stent implantation
Detailed Description:
This is a prospective randomized open-label blinded-endpoint evaluation single-center Study There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital China Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin 50mg daily LD group or Ticagrelor plus regular dose Aspirin 75mg daily control group for 12 months The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events MACCEs and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events sufficiently inhibits platelet function and increases the medication adherence among the included patients In summary the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia
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