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The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewed ticagrelor | Experimental | Ticagrelor pills. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement and after signed informed consent. Patients will be asked to chew, but not to swallow, during at least 40 seconds in presence of investigation staff. Drug: ticagrelor (Brilinta) 90 mg tablets, 2 tablets chewed |
|
| Swallowed ticagrelor | Active Comparator | Ticagrelor integral tablet. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement is drawn. Patients will swallow the loading dose followed by 25-40 ml of water. Drug: ticagrelor (Brilinta) 90 mg tableta, 2 tablets swallowed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chewed ticagrelor | Drug | Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet reactivity | Platelet reactivity measured with VerifyNow (PRU) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (MACCE) | Composite outcome: made by major adverse cardiac and cerebrovascular events: all-cause death, repeat myocardial revascularization, stroke, myocardial infarction | 30 days |
| Composite outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Felipe Barrera RamÃrez, MD | Contact | 8441602269 | carlosfbarrera@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Concepción | Recruiting | Saltillo | Coahuila | Mexico |
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| Swallowed ticagrelor |
| Drug |
Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets |
|
Composite outcome: major bleeding, AND nonmajor clinically relevant (NMCR) bleeding both by ISTH definition
| 30 days |
| Efficacy (long term) | Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined) | 1 year |
| High platelet reactivity on treatment rate | Inhibition of platelet aggregation (IPA) measured by VerifyNow | 1 hour |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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