N/A Completed N=50 Randomized Double-blind Treatment

Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes

Diabetes · Coronary Artery Disease

Source: ClinicalTrials.gov NCT01852214 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcomePrimary: P2Y12 Reaction Units — 83; 52 PRU — p=0.022

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY P2Y12 Reaction Units	97; 75	0.086
SECONDARY P2Y12 Reaction Units	97; 75	0.086
SECONDARY Platelet Reactivity Index	35; 37	—

Eligibility 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 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.

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Data sourced from ClinicalTrials.gov (NCT01852214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.