Status:
COMPLETED
High Ticagrelor Loading Dose in STEMI
Lead Sponsor:
University of Florida
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 fir...
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). Tic...
Eligibility Criteria
Inclusion
- Patients with ST-elevation myocardial infarction undergoing primary PCI.
- Age between 18 and 80 years old.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01898442
Start Date
September 1 2013
End Date
June 1 2014
Last Update
June 8 2015
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209