EndoTic - Endothelium and Ticagrelor

Study Overview
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Brief Summary
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Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).

Detailed Description
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ACS Patients in both treatment groups will be assessed: Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected

Official Title
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EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy

Conditions
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Acute Coronary Syndrome (ACS)

Intervention / Treatment
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* Drug: Ticagrelor vs Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to sign Informed Consent Form 18 yr or older Male and female (post menopause or contraception treatment) ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI) Planned invasive strategy (coronariography performed within 72hrs after admission) Exclusion Criteria: Aspirin, clopidogrel or ticagrelor allergy. Hemorrhagic diathesis or very high risk of bleeding. Current treatment with oral anticoagulants, thienopyridines or ticagrelor. Limited life expectancy. Elective surgery planned. High chance of not being able to complete the follow-up period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br>180mg initial dose next day 90mg BID | Drug: Ticagrelor vs Clopidogrel<br> <br> |
| Active Comparator: Clopidogrel<br>600mg po initial dose and 75mg qd starting next day | Drug: Ticagrelor vs Clopidogrel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cells | EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells) | Baseline | 
| Number of cells | EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells) | 48 hours after last chest pain episode | 
| Number of cells | EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells) | 1 month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity | As determined by P2Y12 kits, VerifyNow® | At the time of coronary angiography | 
| Platelet reactivity | As determined by P2Y12 kits, VerifyNow® | 1 month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Circulating Endothelial Cells, Endothelial Progenitor Cells, Acute coronary syndrome (ACS)