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.

Sponsors

Lead Sponsor: Aurora Health Care

Source Aurora Health Care
Brief Summary

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.

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 TIMI criteria.

Overall Status Active, not recruiting
Start Date 2018-09-19
Completion Date 2021-07-31
Primary Completion Date 2020-12-31
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Concentration of pharmacodynamics 1 hour
Secondary Outcome
Measure Time Frame
Number of Participants with Major adverse cardiac and cerebrovascular event MACCE 30 days
Number of Participants with Major adverse cardiac and cerebrovascular event MACCE 1 year
Enrollment 116
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ticagrelor

Description: Chewed

Arm Group Label: Experimental: Chewed ticagrelor

Intervention Type: Drug

Intervention Name: Ticagrelor

Description: Integral

Arm Group Label: Active Comparator: Integral pill

Eligibility

Criteria:

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 GP IIb-IIIa inhibitors 48-hours before the procedure or any use during the procedure - Any use of Cangrelor during or after the procedure - Hemoglobin <10 g/dL, PLT <100x10^9/L - Pregnancy - Known allergy to study medication

Gender:

All

Minimum Age:

18 Years

Maximum Age:

89 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Thomas F Wilson, MD Principal Investigator Aurora Health Care
Location
Facility: Aurora Health Care, St. Luke's Medical Center
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aurora Health Care

Investigator Full Name: Thomas F. Wilson

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Experimental: Chewed ticagrelor

Type: Experimental

Description: Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline 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)

Label: Active Comparator: Integral pill

Type: Active Comparator

Description: Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News