Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome

Phase 4

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Swallowed ticagrelor; Drug: Chewed ticagrelor

• Registration Number: NCT04567290
• Lead Sponsor: Centro Hospitalario La Concepcion

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-28
• Study Start: 2020-10-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29
• Primary Completion: 2021-08-15
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Swallowed ticagrelor	Swallowed ticagrelor	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
Chewed ticagrelor	Chewed ticagrelor	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

Primary Outcome Measures

Name	Time	Method
Platelet reactivity	1 hour	Platelet reactivity measured with VerifyNow (PRU)

Secondary Outcome Measures

Name	Time	Method
Efficacy (long term)	1 year	Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined)
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
High platelet reactivity on treatment rate	1 hour	Inhibition of platelet aggregation (IPA) measured by VerifyNow

Trial Locations

Locations (1)

Hospital La Concepción; 🇲🇽 Saltillo, Coahuila, Mexico