Clopidogrel Versus Ticagrelor in Type-2 Diabetes

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Diabetes Mellitus

Treatments: Drug: Ticagrelor; Drug: Clopidogrel; Drug: Standard medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02742987

CLOTILDIA

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes mellitus
• stable coronary disease
• coronary revascularization with PCI at least 1 month prior to recruitment

Exclusion criteria

• acute coronary syndrome
• platelet count <70x109/l
• active bleeding or bleeding diathesis
• history of intracranial bleeding
• gastrointestinal bleeding <6 months
• cerebrovascular accident <3 months
• history of malignancy
• concomitant need for oral anticoagulant therapy
• severe liver disease or chronic renal failure (glomerular filtration rate <30 ml/min /1.73m2)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Ticagrelor group

Experimental group

Description:

Ticagrelor 90 mg twice daily + standard medical therapy

Treatment:

Drug: Ticagrelor

Drug: Standard medical therapy

Clopidogrel group

Experimental group

Description:

Clopidogrel 150 mg once daily + standard medical therapy

Treatment:

Drug: Clopidogrel

Drug: Standard medical therapy