Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
Completed · Not applicable
Conditions studied: Coronary Artery Disease
In brief
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 compared with clopidogrel and are associated with an improved net clinical benefit. However, to date there are limited head-to-head comparisons of these two new agents.
Key facts
- Study ID
- NCT01852175
- Run by
- University of Florida
- People needed
- 110
- Starts
- 2012-01-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2015-06-10
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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