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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