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Short-term efficacy and safety of low-dose ticagrelor in acute coronary syndrome patients with high bleeding risk

Status Approved

  • First Submitted Date

    2020/01/08

  • Registered Date

    2020/01/22

  • Last Updated Date

    2023/06/22

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004640
    Unique Protocol ID H-1703-012-066
    Public/Brief Title Short-term efficacy and safety of low-dose ticagrelor in acute coronary syndrome patients with high bleeding risk
    Scientific Title Short-term efficacy and safety of low-dose ticagrelor in acute coronary syndrome patients with high bleeding risk
    Acronym bleeding acs
    MFDS Regulated Study Yes
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number H-1703-012-066
    Approval Date 2017-04-18
    Institutional Review Board Name Pusan ​​National University Hospital Institutional Review Board
    Institutional Review Board Address 179, Gudeok-ro, Seo-gu, Busan
    Institutional Review Board Telephone 051-240-7529
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jinsup Park
    Title associate professor
    Telephone +82-51-240-7944
    Affiliation Pusan National University Hospital
    Address 179, Gudeok-ro, Seo-gu, Busan,
    Contact Person for Public Queries
    Name Jinsup Park
    Title associate professor
    Telephone +82-51-240-7944
    Affiliation Pusan National University Hospital
    Address 179, Gudeok-ro, Seo-gu, Busan,
    Contact Person for Updating Information
    Name Jinsup Park
    Title associate professor
    Telephone +82-51-240-7944
    Affiliation Pusan National University Hospital
    Address 179, Gudeok-ro, Seo-gu, Busan,
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-05-08 Actual
    Target Number of Participant 126
    Primary Completion Date 2020-06-28 , Actual
    Study Completion Date 2020-09-18 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Pusan National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-05-08 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Pusan National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Pusan National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The efficacy of ticagrelor in acute coronary syndrome has been fully demonstrated in PLATO, a prospective randomized study comparing ticagrelor and clopidogrel. Based on this study, the European and American Heart Association guidelines recommended the use of roticagrelor prior to initial and coronary reperfusion procedures in patients with acute coronary syndrome.
    However, this study is mainly conducted for Westerners, and there is a problem that Asians have participated in small scale. Indeed, as known from studies conducted in Asian countries, there have been many studies that ticagrelor's inhibition of platelet function is different from that of Westerners, and even if the degree of platelet inhibition is smaller than that of Westerners, it is not a clinical problem. Rather, the drug called prasugrel, similar to tachygrelor, was more likely to cause bleeding problems than the clinical benefit when the current dose was used. In the case of prasugrel, bleeding frequency was reduced when the dose was lower than the approved dose, but the degree of platelet inhibition was similar. Ticagrelor is also a common side effect, and symptoms of breathing occur mainly at the beginning of drug administration, and the cause is known to be caused by increasing the concentration of adenosine in the blood. The frequency of these breathing symptoms increases in proportion to the dose, which can also be expected to decrease when a dose less than the approved dose is used. These low-dose drug therapies are likely to reduce the frequency of side effects and eventually increase drug compliance. In particular, after cardiovascular reperfusion, drug compliance and the incidence of clinical events are inversely related. Increasing drug compliance eventually plays a major role in reducing the recurrence of cardiac events. When using low dose ticagrelor therapy can be said to be an advantage. The purpose of this study is to evaluate the efficacy and safety of low-dose ticagrelor therapy in patients with acute bleeding.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase4
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    This study is to compare the bleeding frequency of the 90 mg ticagrelor bid group and the 45 mg ticagrelor bid group after evaluating the degree of platelet inhibition in patients with acute coronary artery.
    Number of Arms 1
    Arm 1

    Arm Label

    45mg ticagrelor

    Target Number of Participant

    126

    Arm Type

    Experimental

    Arm Description

    This study is to compare the bleeding frequency of the 90 mg ticagrelor bid group and the 45 mg ticagrelor bid group after evaluating the degree of platelet inhibition in patients with acute coronary artery.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    (I00-I99)Diseases of the circulatory system 

    Acute Coronary Syndrome
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    Acute Coronary Syndrome
    Patients who have completed a successful cardiovascular perfusion procedure
    PRU <90 patients
    Patients who voluntarily signed a research agreement
    Exclusion Criteria
    1. Patients unable to take ticagrelor (severe chronic obstructive pulmonary disease, history of cerebral hemorrhage)
    2. Patients with multi-vascular disease and coronary artery bypass surgery
    3. Moderate-Those with severe liver disease
    4. Those who have bradycardia symptoms such as same-sex bradycardia and atrioventricular conduction block
    5. Those with respiratory distress, such as those with chronic obstructive pulmonary disease.
    6. Pregnant or lactating women
    7. Those who have undergone hemodialysis or peritoneal dialysis due to end stage renal failure and have undergone kidney transplantation
    8. A person who, due to other reasons, judges that participation in a clinical trial is inappropriate.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    BARC bleeding
    Timepoint
    administration, 1month, 6 month
    Secondary Outcome(s) 1
    Outcome
    platelet reactivity unit by VerifyNow
    Timepoint
    administration, 1month
    Secondary Outcome(s) 2
    Outcome
    Borg Dyspnea scale
    Timepoint
    administration, 1month, 6 month
    Secondary Outcome(s) 3
    Outcome
    MACCE(CV death, MI, stroke), major bleeding
    Timepoint
    administration, 1month, 6 month
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Results Upload
    Final Enrollment Number 122
    Number of Publication 0
    Results Upload figure2.jpg
    Date of Posting Results 2021/07/30
    Protocol URL or File Upload figure1.jpg
    Brief Summary
    Bleeding episodes were most commonly observed at 1month and then decreased over time.
    Compared with standard-dose ticagrelor, half-dose ticagrelor did not reduce total bleeding (BARC type 1-5) during 6month (odds ratio(OR) 0.900, 95% confidence interval [CI] 0.563-1.440, p=0.661). 
    However, serious bleeding events (BARC type ≥2) occurred less often in half-dose ticagrelor (OR 0.284, 95% CI 0.088-0.921, p=0.036).
    Likewise, the overall rate of moderate-to-severe dyspnoea was highest at 1 month, then decreased over time.
    Half-dose ticagrelor did not decrease the rate of any dyspnoeaor moderate-to-severe dyspnoea during 6month.
    The risk of ischemic events was also similar between the groups.
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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