Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome (TICA-MASTICA)

Centro Hospitalario La Concepcion

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Chewed ticagrelor; Drug: Swallowed ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT04567290

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Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Chewed ticagrelor

Experimental group

Description:

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

Treatment:

Drug: Chewed ticagrelor

Swallowed ticagrelor

Active Comparator group

Description:

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

Treatment:

Drug: Swallowed ticagrelor