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Chewed Versus Integral Pill of Ticagrelor

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ClinicalTrials.gov Identifier: NCT03708588
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas F. Wilson, 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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Drug: Ticagrelor 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.

    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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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 : September 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

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




Primary Outcome Measures :
  1. Concentration of pharmacodynamics [ Time Frame: 1 hour ]
    Measure platelet reactivity


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708588


Contacts
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Contact: Thomas F Wilson, MD (414) 649-6067 thomas.wilson@aurora.org
Contact: Gina Behr 414-649-6853 gina.behr@auruora.org

Locations
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United States, Wisconsin
Aurora Health Care, St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Wendy Dunaj    414-649-3512    wendy.dunaj@aurora.org   
Principal Investigator: Thomas Wilson, MD         
Sponsors and Collaborators
Aurora Health Care
Investigators
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Principal Investigator: Thomas F Wilson, MD Aurora Health Care

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Responsible Party: Thomas F. Wilson, Principal Investigator, Aurora Health Care
ClinicalTrials.gov Identifier: NCT03708588     History of Changes
Other Study ID Numbers: 18-078_18-911
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Aurora Health Care:
Ticagrelor
Stent

Additional relevant MeSH terms:
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Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs