Status:
COMPLETED
Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
Lead Sponsor:
University of Florida
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects c...
Detailed Description
Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of thrombotic events in patients with coronary artery disease (CAD) undergoing percutaneo...
Eligibility Criteria
Inclusion
- Patients with known coronary artery disease
- On maintenance treatment with aspirin (81 mg per day) and clopidogrel (75 mg per day) for at least 1-month as per standard of care.
- Age between 18 and 74 years old.
Exclusion
- History of stroke, transient ischemic attack or intracranial bleeding.
- Known allergies to aspirin, prasugrel, ticagrelor, or clopidogrel.
- Weight \<60kg
- On treatment with oral anticoagulation (coumarin derivate, dabigatran).
- Hemoglobin\<10 gm/dL
- Platelet count \<80x106/mL
- Active bleeding or hemodynamic instability.
- Creatinine Clearance \<30 mL/minute.
- Baseline ALT \>2.5 times the upper limit of normal.
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
- Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): , fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).
- Drugs interfering 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 :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01852175
Start Date
January 1 2012
End Date
July 1 2014
Last Update
June 10 2015
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209