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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005042-11 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental | 180mg initial dose next day 90mg BID |
|
| Clopidogrel | Active Comparator | 600mg po initial dose and 75mg qd starting next day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor vs Clopidogrel | Drug |
|
| 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 |
| 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® |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Bleeding and ischemic adverse events | Adverse Events collection | 18 months (Study duration) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armando Pérez de Prado, MD, PhD | Fundación Investigación Sanitaria en León | Principal Investigator |
| M. Belen Vidriales Acosta, MD, PhD | University of Salamanca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Santiago | Santiago de Compostela | La Coruña | Spain | |||
| Hospital de Leon |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 23, 2025 | |
| Reset | Apr 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2025 | Apr 10, 2025 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 1 month visit |
| León |
| Leon |
| 24008 |
| Spain |
| Hospital Universitario de Salamanca | Salamanca | Spain |