High Ticagrelor Loading Dose in STEMI
Completed · Phase 2
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01898442
- Run by
- University of Florida
- People needed
- 52
- Starts
- 2013-09-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-06-08
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with ST-elevation myocardial infarction undergoing primary PCI.
- Age between 18 and 80 years old.
You may not qualify if…
- History of prior intracranial bleeding.
- On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 30 days.
- Known allergies to aspirin or ticagrelor.
- On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
- Treatment with IIb/IIIa glycoprotein inhibitors.
- Fibrinolytics within 24 hours
- Known blood dyscrasia or bleeding diathesis.
- Known platelet count <80x106/mL.
- Known hemoglobin <10 g/dL.
- Active bleeding.
- Hemodynamic instability.
- Known creatinine clearance <30 mL/minute.
- Known severe hepatic dysfunction.
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
- Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
- Pregnant females*.
- Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Where it is running
- University of Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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