CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Ticagrelor 180mg +2 moredrug
Likely dose
Ticagrelor 180mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01898442
NCT01898442Phase 2Completed

Pharmacodynamic Profiles of Ticagrelor in Patients With ST Elevation Myocardial Infarction: A Randomized Comparison of Different Loading Dosage Regimens

University of Florida·interventional·Posted Jul 12, 2013·Updated Jun 8, 2015

In Brief

A Phase 2 clinical trial evaluating Ticagrelor 180mg, Ticagrelor 270mg, and 1 other intervention for Coronary Artery Disease. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 12, 2013
Enrollment StartSep 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.0 years ago

Interventions

Ticagrelor 180mgdrug

Rndomization to standard or high ticagrelor loading dose regimens

Ticagrelor 270mgdrug

Randomization to standard or high loading dose regimen

Ticagrelor 360mgdrug

Randomization to standrad or high loading dose regimen