Clopidogrel Versus Ticagrelor in Type-2 Diabetes

Study Overview
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Brief Summary
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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).

Official Title
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CLOpidogrel Versus TIcagreLor for Antiplatelet Maintenance in DIAbetic Patients Treated With Percutaneous Coronary Intervention: Results of the CLOTILDIA Study

Conditions
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Coronary Artery Disease, Diabetes Mellitus

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel
* Drug: Standard medical therapy


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor group<br>Ticagrelor 90 mg twice daily + standard medical therapy | Drug: Ticagrelor<br>* Ticagrelor 90 mg twice daily<br>Drug: Standard medical therapy<br>* Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions<br>|
| Experimental: Clopidogrel group<br>Clopidogrel 150 mg once daily + standard medical therapy | Drug: Clopidogrel<br>* Clopidogrel 150 mg once daily<br>Drug: Standard medical therapy<br>* Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated Dilation of the Brachial Artery | Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Flow-mediated Dilation of the Brachial Artery <7% |  | 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 | 4 weeks | 
| Platelet Reactivity | Platelet reactivity assessed with the VerifyNow P2Y12 Assay | 4 weeks | 
| Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units |  | 4 weeks |