Skip to main content
OpenTrials
Completed

NCT Number: NCT02742987

Clopidogrel Versus Ticagrelor in Type-2 Diabetes

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ticagrelor

Drug

Ticagrelor 90 mg twice daily

clopidogrel

Drug

Clopidogrel 150 mg once daily

Standard Medical Therapy

Drug

Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions

Primary outcomes

  1. Flow-mediated Dilation of the Brachial Artery

    Time frame: 4 weeks

    Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion

Secondary outcomes

  1. Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%

    Time frame: 4 weeks

  2. Endothelium-independent Dilation of the Brachial Artery

    Time frame: 4 weeks

    Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin

  3. Platelet Reactivity

    Time frame: 4 weeks

    Platelet reactivity assessed with the VerifyNow P2Y12 Assay

  4. Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 19, 2016
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.