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Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

CompletedPhase 4

Sponsor: University of Florida

Conditions: Diabetes Mellitus, Type 2, Coronary Artery Disease

Interventions: Ticagrelor monotherapy, Ticagrelor plus aspirin, Clopidogrel with aspirin

Countries: United States

Recent studies have shown that withdrawing aspirin and maintaining P2Y12 inhibitor monotherapy for up to 12 months post-PCI, after a brief period of DAPT, reduces bleeding without increasing ischemic harm. Such effects have shown to of particular benefit in patients with diabetes mellitus (DM). However, if an aspirin-free approach can be considered after this time frame is a matter of debate. The aim of this study is to assess the PD effects of ticagrelor 60 mg with and without aspirin therapy in CAD patients and to compare this with a standard DAPT regimen of aspirin plus clopidogrel.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

For inclusion in the study patients should fulfill the following criteria:

1. Provision of informed consent prior to any study specific procedures
2. Men or women ≥18 years of age
3. Diagnosed with type 2 DM defined by ongoing glucose lowering therapy (oral medications and/or insulin) treatment for at least 1 month
4. Known angiographically defined CAD (including a history of previous PCI, CABG, or \>50% stenosis in a major epicardial vessel) on standard of care antiplatelet therapy\* \*Patients can be treated with any background antiplatelet treatment regimen as part of their standard of care, including aspirin and/or any P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel).

Exclusion criteria:

1. PCI \< 6 months prior
2. Recent (\< 6 months) type I myocardial infarction
3. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study:

* Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir
* CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses \>40 mg daily or lovastatin at doses \>40 mg daily
4. Anticipated concomitant oral or intravenous therapry of strong CYP3A inducers (phenytoin, rifampin, phenobarb, carbamazepine)
5. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses)
6. Patients with known bleeding diathesis or coagulation disorder
7. History of previous intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months prior to randomization, or major surgery within 30 days prior to randomization
8. Active pathological bleeding
9. Hypersensitivity to aspirin, ticagrelor or clopidogrel
10. Increased risk of bradycardic events (eg, known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker
11. Known severe liver disease
12. Renal failure requiring dialysis
13. Known platelet count \<80x106/mL
14. Known hemoglobin \<9 g/dL
15. Pregnant or breastfeeding women. \*Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.

Locations (1)

Jacksonville, Florida, United States