Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01660373
Status:
UNKNOWN
Last Update Posted:
2012-12-18
First Post:
2012-08-05
Brief Title:
Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome
Sponsor:
Pusan National University Yangsan Hospital
Organization:
Pusan National University Yangsan Hospital
Study Overview
Official Title:
Ticagrelor vs Tirofiban Comparison of Anti-platelet Effects in Patients With Non-ST Elevation Acute Coronary SyndromeTE-CLOT Trial Ticagrelors Effect for CLOT Prevention A Single Center Open-label Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2012-12
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:
TE-CLOT
Brief Summary:
This is a single-center open-label prospective randomized pharmacodynamic investigation of two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment elevation acute coronary syndromeNSTE-ACS for 24 hours
1 Ticagrelor loading dose180mg followed by maintenance dose90mg bid
2 Tirofiban 04ugkgmin for 30min followed by 01ugkgmin
both agents will be given on top of aspirin
1 Ticagrelor loading dose180mg followed by maintenance dose90mg bid
2 Tirofiban 04ugkgmin for 30min followed by 01ugkgmin
both agents will be given on top of aspirin
Detailed Description:
In combination with aspirin P2Y12 receptor antagonist or glycoprotein IIbIIIa inhibitorGPI is now a recommended drug as the standard dual antiplatelet regimen in patients with acute coronary syndrome1
Ticagrelor is a newly developed oral P2Y12 receptor inhibitor It shows faster greater and more consistent platelet inhibition as compared with previous P2Y12 receptor antagonist clopidogrel2 and it also shows better clinical outcome and similar risk for bleeding as compared with clopidogrel3Interestingly pharmacodynamic data of some studies showed excellent effect of ticagrelor in terms of inhibiting platelet activation apparently as high as that of GPI24
Primary hypothesis Ticagrelor have a comparable efficacy in platelet inhibition to GPI in patients with non-ST segment elevation acute coronary syndrome
Statistical design non-inferiority test
Ticagrelor is a newly developed oral P2Y12 receptor inhibitor It shows faster greater and more consistent platelet inhibition as compared with previous P2Y12 receptor antagonist clopidogrel2 and it also shows better clinical outcome and similar risk for bleeding as compared with clopidogrel3Interestingly pharmacodynamic data of some studies showed excellent effect of ticagrelor in terms of inhibiting platelet activation apparently as high as that of GPI24
Primary hypothesis Ticagrelor have a comparable efficacy in platelet inhibition to GPI in patients with non-ST segment elevation acute coronary syndrome
Statistical design non-inferiority test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None