Chewed Versus Integral Pill of Ticagrelor

Wake Forest University Health Sciences112 enrolled

Overview

Hypothesis The primary question the investigators propose to answer is whether all patients undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.

Hypothesis The primary question the investigators propose to answer is whether all patients undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration. Secondary Hypotheses: 1. Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year. 1. Death 2. Repeat myocardial infarction 3. Need for urgent revascularization 4. Cerebrovascular accident 2. Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year. 3. Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Percutaneous Coronary Intervention

Interventions

TicagrelorDRUG

Chewed

TicagrelorDRUG

Integral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: • All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention. Exclusion Criteria: * Age \<18 years or Age \>89 years * Known coagulopathy, bleeding diathesis, or active bleeding * History of recent gastrointestinal or genitourinary bleed within 2 months * Known chronic therapy with clopidogrel, prasugrel, or ticagrelor * Major surgery within last 6 weeks * History of intracranial bleed or intracranial neoplasm * Suspected aortic dissection * Severe hemodynamic instability, cardiogenic shock * Life expectancy \<1 year * Known severe liver or renal disease * Known HIV treatment * Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure * Any use of Cangrelor during or after the procedure * Hemoglobin \<10 g/dL, platelet (PLT) \<100x10\^9/L * Pregnancy * Known allergy to study medication

Locations (1)

Aurora Health Care, St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Concentration of Pharmacodynamics

Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU.

Time frame: 1 hour

Secondary Outcomes

Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)

Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding.

Time frame: 30 days

Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)

Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding.

Time frame: 1 year

Data from ClinicalTrials.gov

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