Clopidogrel Versus Ticagrelor in Type-2 Diabetes

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Intervention / Treatment: Drug: Ticagrelor; Drug: Standard medical therapy; Drug: Clopidogrel

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: CLOTILDIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED