Clopidogrel Versus Ticagrelor in Type-2 Diabetes

NCT ID: NCT02742987

Last Updated: 2017-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

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).

Detailed Description

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Conditions

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Coronary Artery Disease Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor group

Ticagrelor 90 mg twice daily + standard medical therapy

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

Ticagrelor 90 mg twice daily

Standard medical therapy

Intervention Type DRUG

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

Clopidogrel group

Clopidogrel 150 mg once daily + standard medical therapy

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Clopidogrel 150 mg once daily

Standard medical therapy

Intervention Type DRUG

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

Interventions

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Ticagrelor

Ticagrelor 90 mg twice daily

Intervention Type DRUG

Clopidogrel

Clopidogrel 150 mg once daily

Intervention Type DRUG

Standard medical therapy

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

Intervention Type DRUG

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Germano Di Sciascio

Prof. Germano Di Sciascio

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CLOTILDIA

Identifier Type: -

Identifier Source: org_study_id

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