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Clopidogrel Versus Ticagrelor in Type-2 Diabetes

Primary Purpose

Coronary Artery Disease, Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ticagrelor

Clopidogrel

Standard medical therapy

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ticagrelor group

Clopidogrel group

Arm Description

Ticagrelor 90 mg twice daily + standard medical therapy

Clopidogrel 150 mg once daily + standard medical therapy

Outcomes

Primary Outcome Measures

Flow-mediated Dilation of the Brachial Artery

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

Secondary Outcome Measures

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

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

Platelet Reactivity

Platelet reactivity assessed with the VerifyNow P2Y12 Assay

Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units

Full Information

NCT ID

NCT02742987

First Posted

March 24, 2016

Last Updated

July 18, 2017

Sponsor

Campus Bio-Medico University

1. Study Identification

Unique Protocol Identification Number

NCT02742987

Brief Title

Clopidogrel Versus Ticagrelor in Type-2 Diabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Campus Bio-Medico University

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ticagrelor group

Arm Type

Experimental

Arm Description

Ticagrelor 90 mg twice daily + standard medical therapy

Arm Title

Clopidogrel group

Arm Type

Experimental

Arm Description

Clopidogrel 150 mg once daily + standard medical therapy

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Intervention Description

Ticagrelor 90 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

Clopidogrel 150 mg once daily

Intervention Type

Drug

Intervention Name(s)

Standard medical therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Flow-mediated Dilation of the Brachial Artery

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Title

Endothelium-independent Dilation of the Brachial Artery

Description

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

Time Frame

4 weeks

Title

Platelet Reactivity

Description

Platelet reactivity assessed with the VerifyNow P2Y12 Assay

Time Frame

4 weeks

Title

Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units

Time Frame

4 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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)

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Clopidogrel Versus Ticagrelor in Type-2 Diabetes

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