Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elec… (NCT04069234) | Clinical Trial Compass
WithdrawnPhase 3
Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention.
Stopped: Sponsor decided to stop the study due to commercial reasons.
0Started 2019-09-15
Plain-language summary
This study is designed to test the hypothesis that ticagrelor is superior to clopidogrel, in improving coronary microvascular function, as measured by coronary flow reserve (CFR) in patients with T2DM at high risk of cardiovascular (CV) events undergoing elective PCI.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures
✓. Men or women ≥18 years of age
✓. Diagnosed with T2DM defined as treatment with ongoing glucose lowering drug (oral medications and/or insulin) for at least 1 month
✓. Presence of CAD undergoing elective PCI
✓. Impaired coronary microvascular function post PCI as defined by a CFR ≤2.5 (as per local reading)
✓. TIMI 3 flow post PCI
Exclusion criteria
✕. Previous MI defined as a documented hospitalization with a final diagnosis of spontaneous MI (with the exception of definite secondary MI \[e.g., due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anemia\]).
✕. Previous stroke (transient ischemic attack \[TIA\] is not included in the stroke definition)
✕. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI
✕. On treatment with clopidogrel, prasugrel, or ticagrelor due to a prior acute major CV event (MI or stroke) (on treatment with clopidogrel due to prior vascular intervention not secondary to a major CV event is allowed)
✕. Planned use of aspirin treatment at doses \>150 mg od
. 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 CYP3A4 inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir
✕. CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses \>40 mg daily or lovastatin at doses \>40 mg daily