Chewed Versus Integral Pill of Ticagrelor

Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Ticagrelor; Drug: Ticagrelor

Detailed Description

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
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health Care, St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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: Experimental: Chewed ticagrelor; Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)	Drug: Ticagrelor; Chewed; Other Names: Brilinta; Brilique; Possia; Drug: Ticagrelor; Integral; Other Names: Brilinta; Brilique; Possia
Active Comparator: Active Comparator: Integral pill; Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL (milliliter) of water. (180mg)	Drug: Ticagrelor; Chewed; Other Names: Brilinta; Brilique; Possia; Drug: Ticagrelor; Integral; Other Names: Brilinta; Brilique; Possia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Suhail Allaqaband, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 13, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Ticagrelor; Stent
• Additional Relevant MeSH Terms: 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: 18-078_18-911

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