Comparison of TIcagrelor and Clopidogrel in Patients With Coronary Artery diseaSe and Type 2 Diabetes Mellitus (TICS-DM)

• Status: Unknown status
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with type 2 diabetes mellitus (T2DM), have a high prevalence of suboptimal response to clopidogrel (up to 40%). This impaired response to antiplatelet drugs has been consistently associated with a higher risk of adverse ischemic outcomes. Different strategies have been suggested to overcome variability in response to clopidogrel and improve clinical outcomes in diabetic patients. One of these strategies is the use of newer P2Y12 inhibitors, such as ticagrelor, with more potent and consistent platelet inhibitory effects compared to clopidogrel. In summary, since patients with T2DM continue to have enhanced platelet reactivity despite the administration of commonly used dual antiplatelet therapy with aspirin and standard doses of clopidogrel, newer and more potent antiplatelet treatment strategies are warranted in this high-risk population. The purpose of the present study is to compare platelet inhibitory effects achieved with ticagrelor versus clopidogrel, both on top of aspirin therapy, in patients with type 2 DM and stable coronary artery disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Society of Cardiology
• Collaborator: AstraZeneca
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures

• Age between 18 and 75 years

• Type 2 DM according to ADA criteria

• Angiographically documented CAD

• Chronic treatment (>1 month) with aspirin (100mg/day)

Exclusion Criteria:

• Known allergies to aspirin, clopidogrel, or ticagrelor

• Blood dyscrasia

• Any recent acute coronary syndrome (<30 days) or hemodinamic instability

• Recent antiplatelet therapy (<14 days), with the exception of ASA, including:

thienopyridines, cilostazol, dipiridamol, glycoprotein IIb/IIIa inhibitors

• Oral anticoagulation with a coumarin derivative

• Concomitant treatment with a potent CYP3A4 inhibitor (e.g. ketoconazole, claritromicine, nefazodone, ritonavir, atazanavir)

• Any active bleeding

• Recent history of stroke, TIA or intracranial bleeding (<6 months prior to inclusion)

• Platelet count <100x106/microl

• Severe chronic kidney disease (creatinine clearance measured with Cockcroft-Gault formula <30ml/min)

• Any active neoplasm

• Baseline ALT >2.5 times the upper limit of normality

• Pregnant or childbearing females