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BRILIQUE: Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor

Sponsor
Örebro University, Sweden (Other)
Overall Status
Completed
CT.gov ID
NCT02297971
Collaborator
(none)
25
Enrollment
1
Location
24
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of bleeding when it is continued peri-operatively have to be weighed against the risk of coronary artery thrombosis when stopped. This study aims to assess coagulation and thrombocyte function every other day in patients who are taking ticagrelor after coronary artery stents and discontinue therapy at the end of one year.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients who have an acute coronary syndrome are today often treated by percutaneous coronary intervention (PCI) and insertion of one or several coronary stents. Subsequently, these patients are treated with oral anti-platelet (OAP) drugs, usually a combination of acetyl salicylic acid (aspirin) and clopidogrel/ticagrelor. Although aspirin is continued for a life-long period, clopidogrel/ticagrelor are used for a variable period of time, often from 3 months - 1 year after PCI, depending on the type of stent. Interventional elective non-cardiac surgery during the time of clopidogrel/ticagrelor therapy is not recommended except for life-threatening (acute surgery) or life-prolonging (cancer surgery) procedures. Specifically for life-prolonging procedures, surgery can be planned, and therefore the question often arises as to when OAPs should be terminated prior to planned surgery. This decision rests on balancing the risks of bleeding (when continued) or coronary stent thrombosis (when stopped). Certainly, because of the small risk of severe bleeding when using aspirin, this drug should be continued throughout the perioperative period in patients with coronary stents. However, continuing clopidogrel/ticagrelor is more controversial since severe perioperative bleeding is difficult to reverse in these patients. Therefore, surgeons would normally discontinue clopidogrel/ticagrelor prior to surgery, specifically when the potential for bleeding is high, and the consequences major. The exact duration for which these drugs should be discontinued remains unclear and, depending on the drug used, a period of 3 - 5 days is generally recommended, based on the pharmacokinetics and dynamics of clopidogrel/ticagrelor in otherwise healthy patients.

    This study was done to better understand coagulation and thrombocyte function immediately before discontinuation of ticagrelor and at regular intervals after termination, in patients who have previously undergone PCI, have coronary stents, are taking ticagrelor but discontinue it after one-year of therapy in accordance with hospital routines. No surgical intervention was planned in these patients after termination of ticagrelor.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor in Patients Who Have Previously Undergone PCI Procedures and Insertion of Coronary Stents
    Study Start Date :
    Sep 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Platelet aggregometry [0 - 10 days]

      Platelet aggregometry using Multiplate assay would be done prior to termination of ticagrelor treatment and thereafter every other day of 10 days.

    Secondary Outcome Measures

    1. Thromboelstography [0-10 days]

      Thromboelastography would be performed prior to termination of ticagrelor treatment and thereafter every other day of 10 days.

    2. Coagulation function tests [0-10 days]

      Coagulation function would be performed on alternate days starting before termination of ticagrelor.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who are on the Cardiology Clinic's database at the University Hospital, Örebro and shall terminate ticagrelor after one year following PCI and stent placement would be identified and offered to take part in this study.
    Exclusion Criteria:
    • Non-responders (not partial responders) to ticagrelor would be excluded from the study. Additionally, patients who are either taking NSAID's regularly or during the last 2 weeks prior to study start would also be excluded as those who have language or cognitive limitations.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Örebro Sweden 701 85

    Sponsors and Collaborators

    • Örebro University, Sweden

    Investigators

    • Principal Investigator: Anil Gupta, MD, PhD, Örebro University, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anil Gupta, Associate Professor, Örebro University, Sweden
    ClinicalTrials.gov Identifier:
    NCT02297971
    Other Study ID Numbers:
    • 2013/001
    First Posted:
    Nov 21, 2014
    Last Update Posted:
    Sep 29, 2015
    Last Verified:
    Sep 1, 2015

    Study Results

    No Results Posted as of Sep 29, 2015