Coronary Artery Disease, Diabetes Mellitus
Conditions
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).
Interventions
DRUGTicagrelor
Ticagrelor 90 mg twice daily
DRUGClopidogrel
Clopidogrel 150 mg once daily
DRUGStandard medical therapy
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated Dilation of the Brachial Artery | 4 weeks | Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Flow-mediated Dilation of the Brachial Artery <7% | 4 weeks | — |
| Endothelium-independent Dilation of the Brachial Artery | 4 weeks | Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin |
| Platelet Reactivity | 4 weeks | Platelet reactivity assessed with the VerifyNow P2Y12 Assay |
| Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units | 4 weeks | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ticagrelor Group Ticagrelor 90 mg twice daily + standard medical therapy
Ticagrelor: Ticagrelor 90 mg twice daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions | 21 |
| Clopidogrel Group Clopidogrel 150 mg once daily + standard medical therapy
Clopidogrel: Clopidogrel 150 mg once daily
Standard medical therapy: Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Ticagrelor Group | Clopidogrel Group | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 9.5 | 67.7 years STANDARD_DEVIATION 8.1 | 66.8 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Italy | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 1 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Flow-mediated Dilation of the Brachial Artery
Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor Group | Flow-mediated Dilation of the Brachial Artery | 16.6 FMD (%) | Standard Deviation 4.8 |
| Clopidogrel Group | Flow-mediated Dilation of the Brachial Artery | 11.6 FMD (%) | Standard Deviation 3.9 |
Secondary
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
Time frame: 4 weeks
Secondary
Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%
Time frame: 4 weeks
Secondary
Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units
Time frame: 4 weeks
Secondary
Platelet Reactivity
Platelet reactivity assessed with the VerifyNow P2Y12 Assay
Time frame: 4 weeks