Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01852214
- Run by
- University of Florida
- People needed
- 50
- Starts
- 2013-02-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2016-10-17
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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