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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Chewed ticagrelor; Drug: Swallowed ticagrelor

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carlos Felipe Barrera Ramírez, MD; Phone Number: 8441602269; Email: carlosfbarrera@yahoo.com

Study Locations

• Mexico
  • Coahuila
    • Saltillo, Coahuila, Mexico
      • Recruiting
      • Hospital La Concepción
      • Contact: Carlos Felipe Barrera Ramírez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Chewed ticagrelor; Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
Active Comparator: 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	Drug: Swallowed ticagrelor; Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet reactivity	Platelet reactivity measured with VerifyNow (PRU)	1 hour

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centro Hospitalario La Concepcion

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Anticipated): August 15, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Ticagrelor; Acute coronary syndrome; Platelet aggregation inhibitors; VerifyNow
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No