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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor group | Experimental | Ticagrelor 90 mg twice daily + standard medical therapy |
|
| Clopidogrel group | Experimental | Clopidogrel 150 mg once daily + standard medical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Ticagrelor 90 mg twice daily |
| |
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Flow-mediated Dilation of the Brachial Artery <7% | 4 weeks | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Clopidogrel Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Flow-mediated Dilation of the Brachial Artery | Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion | Posted | Mean | Standard Deviation | FMD (%) | 4 weeks |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fabio Mangiacapra | Campus Bio-Medico University | 003906225411612 | f.mangiacapra@unicampus.it |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Drug |
Clopidogrel 150 mg once daily |
|
| Standard medical therapy | Drug | Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions |
|
| 4 weeks |
| Platelet Reactivity | Platelet reactivity assessed with the VerifyNow P2Y12 Assay | 4 weeks |
| Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units | 4 weeks |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Patients With Flow-mediated Dilation of the Brachial Artery <7% | Not Posted | 4 weeks | Participants |
| 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 | Not Posted | 4 weeks | Participants |
| Secondary | Platelet Reactivity | Platelet reactivity assessed with the VerifyNow P2Y12 Assay | Not Posted | 4 weeks | Participants |
| Secondary | Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units | Not Posted | 4 weeks | Participants |
| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | 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 | 0 | 21 | 0 | 21 | 0 | 21 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |