Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.