Back to resultsPharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome (TICA-MASTICA)
Primary Purpose
Acute Coronary Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Chewed ticagrelor
Swallowed ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Ticagrelor, Platelet aggregation inhibitors, VerifyNow, Acute coronary syndrome
Eligibility Criteria
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
Sites / Locations
- Hospital La ConcepciónRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chewed ticagrelor
Swallowed ticagrelor
Arm 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
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
Outcomes
Primary Outcome Measures
Platelet reactivity
Platelet reactivity measured with VerifyNow (PRU)
Secondary Outcome Measures
Efficacy (MACCE)
Composite outcome: made by major adverse cardiac and cerebrovascular events: all-cause death, repeat myocardial revascularization, stroke, myocardial infarction
Composite outcome
Composite outcome: major bleeding, AND nonmajor clinically relevant (NMCR) bleeding both by ISTH definition
Efficacy (long term)
Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined)
High platelet reactivity on treatment rate
Inhibition of platelet aggregation (IPA) measured by VerifyNow
Full Information
NCT ID
NCT04567290
First Posted
September 21, 2020
Last Updated
July 28, 2021
Sponsor
Centro Hospitalario La Concepcion
1. Study Identification
Unique Protocol Identification Number
NCT04567290
Brief Title
Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome
Acronym
TICA-MASTICA
Official Title
Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Hospitalario La Concepcion
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Ticagrelor, Platelet aggregation inhibitors, VerifyNow, Acute coronary syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chewed ticagrelor
Arm Type
Experimental
Arm 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
Arm Title
Swallowed ticagrelor
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Chewed ticagrelor
Intervention Description
Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
Intervention Type
Drug
Intervention Name(s)
Swallowed ticagrelor
Intervention Description
Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
Primary Outcome Measure Information:
Title
Platelet reactivity
Description
Platelet reactivity measured with VerifyNow (PRU)
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Efficacy (MACCE)
Description
Composite outcome: made by major adverse cardiac and cerebrovascular events: all-cause death, repeat myocardial revascularization, stroke, myocardial infarction
Time Frame
30 days
Title
Composite outcome
Description
Composite outcome: major bleeding, AND nonmajor clinically relevant (NMCR) bleeding both by ISTH definition
Time Frame
30 days
Title
Efficacy (long term)
Description
Composite outcome: number of participants with major adverse cardiac and cerebrovascular events (MACCE) (previously defined)
Time Frame
1 year
Title
High platelet reactivity on treatment rate
Description
Inhibition of platelet aggregation (IPA) measured by VerifyNow
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Felipe Barrera Ramírez, MD
Phone
8441602269
Email
carlosfbarrera@yahoo.com
Facility Information:
Facility Name
Hospital La Concepción
City
Saltillo
State/Province
Coahuila
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Felipe Barrera Ramírez, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome
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