CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with percutaneous coronary intervention (PCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Ticagrelor 90 mg twice daily
Clopidogrel 150 mg once daily
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Flow-mediated Dilation of the Brachial Artery
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion
Time frame: 4 weeks
Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%
Time frame: 4 weeks
Endothelium-independent Dilation of the Brachial Artery
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin
Time frame: 4 weeks
Platelet Reactivity
Platelet reactivity assessed with the VerifyNow P2Y12 Assay
Time frame: 4 weeks
Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units
Time frame: 4 weeks
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