Status:
COMPLETED
Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes
Lead Sponsor:
University of Florida
Conditions:
Diabetes Mellitus
Coronary Artery Disease
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief 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 antiplatele...
Detailed Description
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 antiplatele...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01852214
Start Date
February 1 2013
End Date
August 1 2015
Last Update
October 17 2016
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209