Acute Coronary Syndrome
Conditions
Keywords
Ticagrelor, Platelet aggregation inhibitors, VerifyNow, Acute coronary syndrome
Brief summary
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
Interventions
DRUGChewed ticagrelor
Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
DRUGSwallowed ticagrelor
Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
Sponsors
Centro Hospitalario La Concepcion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention
Exclusion criteria
* Age \<18 years * Known coagulopathy, bleeding diathesis, or active bleeding * History of recent gastrointestinal or genitourinary bleeding within 2 months * Previous therapy with clopidogrel, prasugrel, or ticagrelor * Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure * Major surgery within 6 weeks * History of intracranial bleeding or intracraneal neoplasm * Suspected aortic dissection * Chronic obstructive pulmonary disease * Severe hemodynamic instability or cardiogenic shock * Resuscitated cardiac arrest * Use of vitamin K anticoagulants or novel oral anticoagulants (NOACs) within 7 days * Life expectancy \<1 year * Known severe liver or renal disease, GFR estimated by CKD-EPI \<30 ml/min/1.73 m2 * Known HIV treatment * Hemoglobin \<10 g/dL * Platelet count \<100,000/L * Pregnancy * Known allergy to ticagrelor * Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet reactivity | 1 hour | Platelet reactivity measured with VerifyNow (PRU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High platelet reactivity on treatment rate | 1 hour | Inhibition of platelet aggregation (IPA) measured by VerifyNow |
| Efficacy (MACCE) | 30 days | Composite outcome: made by major adverse cardiac and cerebrovascular events: all-cause death, repeat myocardial revascularization, stroke, myocardial infarction |
| Composite outcome | 30 days | Composite outcome: major bleeding, AND nonmajor clinically relevant (NMCR) bleeding both by ISTH definition |
| Efficacy (long term) | 1 year | Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined) |
Countries
Mexico
Contacts
Primary ContactCarlos Felipe Barrera Ramírez, MD
Outcome results
None listed