Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04116931
Status:
UNKNOWN
Last Update Posted:
2020-08-25
First Post:
2019-09-26
Brief Title:
OPTImal Management of Antithrombotic Agents OPTIMA-5
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents OPTIMA-5
Status:
UNKNOWN
Status Verified Date:
2020-08
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:
This is a prospective randomized open-label clinical trial which will enroll 80 acute coronary syndrome ACS patients after Percutaneous Transluminal Coronary Intervention PCI in China Patients on maintenance dosing MD of aspirin 100 mgd and ticagrelor 90 mg twice daily will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose LD 75 mg MD according to their bleeding risk Then each group will randomly switch at different times24 hours 12 hours after the last MD of ticagrelor Pharmacodynamic assessments are performed at baseline and at 4h 8h 24h 48h 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method LTA All patients are followed-up for 30 days
Detailed Description:
The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry methodLTA Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint MACE defined as a composite of cardiovascular death recurrent myocardial infarction target vessel revascularisation or stroke and individual components of the MACE Safety endpoints of 30-day TIMI major and minor bleed were also evaluated
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?:
False
Is an FDA AA801 Violation?:
None