Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with diabetes mellitus (DM) have an increased risk of adverse atherothrombotic events. This may be in part attributed to the fact that these patients have reduced response to oral antiplatelet medications, in particular the P2Y12 receptor inhibitor clopidogrel, used for secondary prevention of ischemic events. Prasugrel and ticagrelor are recently approved P2Y12 receptor inhibitors which, compared with clopidogrel, have more potent antiplatelet effects. Head-to-head comparisons between the two drugs are lacking.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with known (angiographically documented) CAD.

• On maintenance treatment with aspirin (81 mg per day) for at least 1-month as per standard of care.

• Type 2 DM on treatment with oral hypoglycemic agents and/or insulin.

• Age between 18 and 74 years old.

Exclusion Criteria:

• History of stroke, transient ischemic attack or intracranial bleeding.

• On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor).

• Known allergies to aspirin, ticlopidine, clopidogrel, prasugrel, ticagrelor.

• Weight <60kg.

• On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran).

• Blood dyscrasia or bleeding diathesis.

• Platelet count <80x106/mL.

• Hemoglobin <10 g/dL.

• Active bleeding or hemodynamic instability.

• Creatinine Clearance <30 mL/minute.

• Baseline ALT >2.5 times the upper limit of normal.

• Hb A1c ≥ 10 mg/dL within 3 months.

• Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.

• 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.