Comparison of TIcagrelor and Clopidogrel in Patients With Coronary Artery diseaSe and Type 2 Diabetes Mellitus (TICS-DM) (TICS-DM)
Coronary Artery Disease, Diabetes Mellitus. Type 2
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- Hospital Universitari de Bellvitge - IDIBELLRecruiting
- Hospital Clínico San Carlos
- Hospital Clínico Universitario Virgen de la Arrixaca
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A
Group B
After providing written informed consent, eligible subjects will be randomized in a 1:1 fashion to group A or B. Ticagrelor (180-mg loading dose the first day followed by 90-mg b.i.d. maintenance dose) for one week; washout period of 2-4 weeks; crossover to clopidogrel (600-mg loading dose the first day followed by 75-mg daily maintenance dose) for one-week.
After providing written informed consent, eligible subjects will be randomized in a 1:1 fashion to group A or B. Clopidogrel (600-mg loading dose the first day followed by 75-mg daily maintenance dose) for one-week; washout period of 2-4 weeks; crossover to ticagrelor (180-mg loading dose the first day followed by 90-mg b.i.d. maintenance dose) for one week.