Clopidogrel Versus Ticagrelor in Type-2 Diabetes

NCT02742987 | Completed Phase 4 Results

• 1 other identifier: CLOTILDIA
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Coronary Artery Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  4 weeks

• Endothelium-independent Dilation of the Brachial Artery

  4 weeks

• Platelet Reactivity

  4 weeks

• Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units

  4 weeks

Study Arms (2)

Ticagrelor group

EXPERIMENTAL

Ticagrelor 90 mg twice daily + standard medical therapy

Drug: Ticagrelor; Drug: Standard medical therapy

Clopidogrel group

EXPERIMENTAL

Clopidogrel 150 mg once daily + standard medical therapy

Drug: Clopidogrel; Drug: Standard medical therapy

Interventions

Ticagrelor DRUG

Ticagrelor 90 mg twice daily

Ticagrelor group

Clopidogrel DRUG

Clopidogrel 150 mg once daily

Clopidogrel group

Standard medical therapy DRUG

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

Clopidogrel group; Ticagrelor group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Campus Bio-Medico University: lead

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Fabio Mangiacapra
• Organization: Campus Bio-Medico University

f.mangiacapra@unicampus.it

003906225411612

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Germano Di Sciascio

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 19, 2016
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 17, 2017
• Results First Posted: August 17, 2017

Record last verified: 2017-07