Clopidogrel Versus Ticagrelor in Type-2 Diabetes

Phase 4

Completed

• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor; Drug: Standard medical therapy

• Registration Number: NCT02742987
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Status Verified: 2017-07
• Results First Submitted: 2017-07-18
• Results First Submitted QC: 2017-07-18
• Last Update Submitted: 2017-07-18
• Results First Posted: 2017-08-17
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clopidogrel group	Clopidogrel	Clopidogrel 150 mg once daily + standard medical therapy
Ticagrelor group	Standard medical therapy	Ticagrelor 90 mg twice daily + standard medical therapy
Clopidogrel group	Standard medical therapy	Clopidogrel 150 mg once daily + standard medical therapy
Ticagrelor group	Ticagrelor	Ticagrelor 90 mg twice daily + standard medical therapy

Primary Outcome Measures

Name	Time	Method
Flow-mediated Dilation of the Brachial Artery	4 weeks	Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion

Secondary Outcome Measures

Name	Time	Method
Platelet Reactivity	4 weeks	Platelet reactivity assessed with the VerifyNow P2Y12 Assay
Endothelium-independent Dilation of the Brachial Artery	4 weeks	Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin
Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%	4 weeks
Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units	4 weeks