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Chewed Versus Integral Pill of Ticagrelor

Sponsor
Aurora Health Care (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03708588
Collaborator
(none)
116
Enrollment
1
Location
2
Arms
34.4
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

  2. Death

  3. Repeat myocardial infarction

  4. Need for urgent revascularization

  5. Cerebrovascular accident

  6. Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year.

  7. Bleeding: Defined as major, minor, or minimal bleeding based on TIMI criteria.

Study Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.
Actual Study Start Date :
Sep 19, 2018
Actual Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

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 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

    		•
    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 PRU level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL of water. (180mg)

    Drug: Ticagrelor
    Integral
    Other Names:
  • Brilinta
  • Brilique
  • Possia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentration of pharmacodynamics [1 hour]

      Measure platelet reactivity

    Secondary Outcome Measures

    1. Number of Participants with Major adverse cardiac and cerebrovascular event MACCE [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 [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aurora Health Care, St. Luke's Medical Center Milwaukee Wisconsin United States 53215

    Sponsors and Collaborators

    • Aurora Health Care

    Investigators

    • Principal Investigator: Thomas F Wilson, MD, Aurora Health Care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas F. Wilson, Principal Investigator, Aurora Health Care
    ClinicalTrials.gov Identifier:
    NCT03708588
    Other Study ID Numbers:
    • 18-078_18-911
    First Posted:
    Oct 17, 2018
    Last Update Posted:
    May 21, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Thomas F. Wilson, Principal Investigator, Aurora Health Care
    Ticagrelor
    Stent
    Additional relevant MeSH terms:
    Ticagrelor

    Study Results

    No Results Posted as of May 21, 2021