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OpenTrials
Completed

NCT Number: NCT03708588

Chewed Versus Integral Pill of Ticagrelor

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aurora Health Care, St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

About this study

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:

  • Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year.
  • Death
  • Repeat myocardial infarction
  • Need for urgent revascularization
  • Cerebrovascular accident
  • Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year.
  • Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

Chewed

Other names: Brilinta, Brilique, Possia

Primary outcomes

  1. Concentration of Pharmacodynamics

    Time frame: 1 hour

    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.

Secondary outcomes

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

    Time frame: 30 days

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

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

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 17, 2018
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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