Chewed Versus Integral Pill of Ticagrelor

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708588
• Other study ID #: 18-078_18-911
• Status: Completed
• Phase: Phase 4
• Start date: September 19, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: November 2022
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Drug:
• Ticagrelor
Chewed
• Ticagrelor
Integral

Locations

Country	Name	City	State
United States	Aurora Health Care, St. Luke's Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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