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

Acute Coronary Syndrome Clinical Trial

— TICA-MASTICA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567290
• Other study ID #: 12345
• Status: Recruiting
• Phase: Phase 4
• Start date: October 7, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2021
• Source: Centro Hospitalario La Concepcion
• Contact: Carlos Felipe Barrera Ramírez, MD
• Phone: 8441602269
• Email: carlosfbarrera[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Chewed ticagrelor
Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
• Swallowed ticagrelor
Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets

Locations

Country	Name	City	State
Mexico	Hospital La Concepción	Saltillo	Coahuila

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalario La Concepcion

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reactivity	Platelet reactivity measured with VerifyNow (PRU)	1 hour
Secondary	Efficacy (MACCE)	Composite outcome: made by major adverse cardiac and cerebrovascular events: all-cause death, repeat myocardial revascularization, stroke, myocardial infarction	30 days
Secondary	Composite outcome	Composite outcome: major bleeding, AND nonmajor clinically relevant (NMCR) bleeding both by ISTH definition	30 days
Secondary	Efficacy (long term)	Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined)	1 year
Secondary	High platelet reactivity on treatment rate	Inhibition of platelet aggregation (IPA) measured by VerifyNow	1 hour