Status:
COMPLETED
Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus
Lead Sponsor:
University of Florida
Collaborating Sponsors:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard of care for the prevention of thrombotic complications in patients with coronary artery disease (CAD) undergoing per...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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).
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04484259
Start Date
March 31 2021
End Date
June 15 2024
Last Update
March 30 2025
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209