Ignite Creation Date:
2024-05-06 @ 1:46 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01898442
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2013-07-01
Brief Title:
High Ticagrelor Loading Dose in STEMI
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pharmacodynamic Profiles of Ticagrelor in Patients With ST Elevation Myocardial Infarction A Randomized Comparison of Different Loading Dosage Regimens
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
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:
Ticagrelor is a reversible direct acting P2Y12 antagonist which has shown to be superior to clopidogrel in adjunct to aspirin in preventing recurrent ischemic events Ticagrelor is considered a first line therapy to be administered as soon as possible in ACS patients However the pharmacodynamic effects of ticagrelor at the recommended 180mg loading dose are delayed in patients with STEMI undergoing primary PCI The use of higher loading dose regimens of ticagrelor has therefore been advocated The proposed investigation will have a prospective randomized parallel design in which STEMI patients undergoing primary PCI will be randomized to receive three different loading dose of ticagrelor 180 mg 270 mg and 360 mg Pharmacodynamic testing will be performed at several time points to test our study hypothesis that a higher loading dose regiment will achieve more promptly enhanced platelet inhibitory effects
Detailed Description:
Dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist is the cornerstone of treatment for prevention of thrombotic events in patients with acute coronary syndromes ACS Ticagrelor is a reversible direct acting P2Y12 antagonist which has shown to be superior to clopidogrel in adjunct to aspirin in preventing recurrent ischemic events including cardiovascular mortality Ticagrelor was recently approved for clinical use in ACS patients at a dose of 180 mg loading dose and 90 mg twiceday maintenance dose Ticagrelor is considered a first line therapy to be administered as soon as possible in ACS patients including those presenting with ST-elevation myocardial infarction STEMI undergoing primary percutaneous coronary intervention PCI However there are discordant data on the onset of its antiplatelet effects in this particular setting In particular the pharmacodynamic effects of ticagrelor at the recommended 180mg loading dose are delayed in patients with STEMI undergoing primary PCI The use of higher loading dose regimens of ticagrelor has therefore been advocated However if the administration of a higher ticagrelor loading dose may overcome this limitation is still unknown and represents the aim of our study The proposed investigation will have a prospective randomized parallel design in which STEMI patients undergoing primary PCI will be randomized to receive three different loading dose of ticagrelor 180 mg 270 mg and 360 mg Pharmacodynamic testing will be performed at several time points to test our study hypothesis that a higher loading dose regiment will achieve more promptly enhanced platelet inhibitory effects This study will provide insights on the pharmacodynamic effects of higher ticagrelor loading doses and will help clinicians choose the most appropriate treatment to avoid complications related to inadequate platelet inhibition in the early phase of patients with STEMI undergoing primary PCI
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