Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT04484259

Run by

University of Florida

People needed

105

Starts

2021-03-31

Expected to finish

2024-06-15

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the study patients should fulfill the following criteria:
• Provision of informed consent prior to any study specific procedures
• Men or women ≥18 years of age
• Diagnosed with type 2 DM defined by ongoing glucose lowering therapy (oral medications and/or insulin) treatment for at least 1 month
• 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).

You may not qualify if…

• PCI < 6 months prior
• Recent (< 6 months) type I myocardial infarction
• 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
• Anticipated concomitant oral or intravenous therapry of strong CYP3A inducers (phenytoin, rifampin, phenobarb, carbamazepine)
• Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses)
• Patients with known bleeding diathesis or coagulation disorder
• 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
• Active pathological bleeding
• Hypersensitivity to aspirin, ticagrelor or clopidogrel
• 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
• Known severe liver disease
• Renal failure requiring dialysis
• Known platelet count <80x106/mL
• Known hemoglobin <9 g/dL
• Pregnant or breastfeeding women. *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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