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The Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI)

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketotifen Fumarate
standard treatment
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring ketotifen, STEMI, mast cell, prognosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages above 18 and below 80, gender is not limited;
  • Meet the diagnostic criteria for STEMI (diagnostic criteria: ischemic chest pain lasting ≥30 min; ST segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevation of myocardial markers) , have completed primary PCI, and received standard treatment according to the Chinese "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2019)", including dual antiplatelet, anticoagulation, beta receptor Blockers, statins, etc.
  • No contraindications to ketotifen;
  • Agree and cooperate with participating in this research.

Exclusion Criteria:

  • Severe heart failure, such as Killip grade III-IV or LVEF <35%;
  • Coronary artery bypass grafting within the past 3 years or planned;
  • The patient is using or planning to use long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed);
  • Patients with severe liver and kidney disease;
  • Patients with a history of cancer or lymphoproliferative diseases in the past 3 years;
  • Implanted metal in the body or claustrophobia cannot accept cardiac MRI;
  • Pregnancy or breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    ketotifen

    Control group

    Arm Description

    Ketotifen was added to the standard treatment within 24 hours after the completion of primary PCI for 3 months, taking 1 mg each time, 1-2 times a day according to the patient's tolerance.

    Standard treatment according to guidelines

    Outcomes

    Primary Outcome Measures

    Myocardial infarct size
    Myocardial infarct size was assessed by cardiac MRI

    Secondary Outcome Measures

    left ventricular systolic function
    Transthoracic echocardiography to measure LVEF, left ventricular end-diastolic diameter, Em/Sm
    Left ventricular ultrasound strain
    Two-dimensional speckle tracking imaging measures the movement in the long-axis direction as the overall longitudinal strain, the movement in the short-axis direction as the overall radial strain, reflecting the degree of wall systolic thickening, and the annular motion in the short-axis direction as the overall circumferential strain
    inflammatory factors and MC markers
    Analysis of inflammatory factors (such as TNF-α, IL1, IL6, etc.) and MC markers (chymotrypsin)
    major adverse cardiovascular events
    MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)
    Drug-Related Adverse Reactions
    Fatigue, lethargy and lethargy, nausea and other gastrointestinal adverse reactions

    Full Information

    First Posted
    August 19, 2022
    Last Updated
    August 22, 2022
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05511831
    Brief Title
    The Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI
    Official Title
    A Randomized Controlled Study on the Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the efficacy and safety of ketotifen (MC stabilizer) on the basis of standard treatment after primary PCI in STEMI patients. The ketotifen group and the control group were the ketotifen group and the control group. The control group continued to receive STEMI standard treatment. The ketotifen group received ketotifen for 3 months on the basis of standard treatment within 24 hours after primary PCI, and was followed up for 1 year. Infarct size, as well as differences in echocardiography, markers of two-dimensional speckle tracking, inflammatory factors and MC markers, and major adverse cardiovascular events.
    Detailed Description
    Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute ST-segment elevation myocardial infarction (STEMI). However, STEMI after PCI may still have ischemia-reperfusion injury, inappropriate ventricular remodeling and myocardial fibrosis, which may be related to the inflammatory response of STEMI. Mast cells (MCs) and their degranulation products play an important role in the inflammatory response as well as inducing a series of inflammatory factors. It has been observed in animal experiments that MC stabilizers can improve the ejection fraction, reduce myocardial infarction size and myocardial fibrosis in patients with STEMI, but there is a lack of clinical studies to confirm the role of MC stabilizers in STEMI. The purpose of this study was to evaluate the efficacy and safety of ketotifen (MC stabilizer) on the basis of standard treatment after primary PCI in STEMI patients. The ketotifen group and the control group were the ketotifen group and the control group. The control group continued to receive STEMI standard treatment. The ketotifen group received ketotifen for 3 months on the basis of standard treatment within 24 hours after primary PCI, and was followed up for 1 year. Infarct size, as well as differences in echocardiography, markers of two-dimensional speckle tracking, inflammatory factors and MC markers, and major adverse cardiovascular events, to demonstrate that ketotifen can reduce ischemia-reperfusion injury and improve ventricular reperfusion in AMI. It provides new ideas for the treatment of AMI and a new basis for the optimization of STEMI treatment strategies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ST-segment Elevation Myocardial Infarction (STEMI)
    Keywords
    ketotifen, STEMI, mast cell, prognosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ketotifen
    Arm Type
    Experimental
    Arm Description
    Ketotifen was added to the standard treatment within 24 hours after the completion of primary PCI for 3 months, taking 1 mg each time, 1-2 times a day according to the patient's tolerance.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    Standard treatment according to guidelines
    Intervention Type
    Drug
    Intervention Name(s)
    Ketotifen Fumarate
    Other Intervention Name(s)
    Ketotifen
    Intervention Description
    Ketotifen treatment for 3 months, 1 mg each time, 1-2 times a day according to the patient's tolerance
    Intervention Type
    Drug
    Intervention Name(s)
    standard treatment
    Other Intervention Name(s)
    standard
    Intervention Description
    Standard treatment methods will be determined according to the Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2019) [19], including primary PCI, dual antiplatelet, anticoagulation, ACEI/ARB/ARNI, β-receptor blockade drugs, statins, etc.
    Primary Outcome Measure Information:
    Title
    Myocardial infarct size
    Description
    Myocardial infarct size was assessed by cardiac MRI
    Time Frame
    3 months after myocardial infarction
    Secondary Outcome Measure Information:
    Title
    left ventricular systolic function
    Description
    Transthoracic echocardiography to measure LVEF, left ventricular end-diastolic diameter, Em/Sm
    Time Frame
    24 hours, 1 month, 3 months, and 12 months after myocardial infarction
    Title
    Left ventricular ultrasound strain
    Description
    Two-dimensional speckle tracking imaging measures the movement in the long-axis direction as the overall longitudinal strain, the movement in the short-axis direction as the overall radial strain, reflecting the degree of wall systolic thickening, and the annular motion in the short-axis direction as the overall circumferential strain
    Time Frame
    24 hours, 1 month, 3 months, and 12 months after myocardial infarction
    Title
    inflammatory factors and MC markers
    Description
    Analysis of inflammatory factors (such as TNF-α, IL1, IL6, etc.) and MC markers (chymotrypsin)
    Time Frame
    24 hours, 1 month, 3 months, and 12 months after myocardial infarction
    Title
    major adverse cardiovascular events
    Description
    MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)
    Time Frame
    12 months
    Title
    Drug-Related Adverse Reactions
    Description
    Fatigue, lethargy and lethargy, nausea and other gastrointestinal adverse reactions
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ages above 18 and below 80, gender is not limited; Meet the diagnostic criteria for STEMI (diagnostic criteria: ischemic chest pain lasting ≥30 min; ST segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevation of myocardial markers) , have completed primary PCI, and received standard treatment according to the Chinese "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2019)", including dual antiplatelet, anticoagulation, beta receptor Blockers, statins, etc. No contraindications to ketotifen; Agree and cooperate with participating in this research. Exclusion Criteria: Severe heart failure, such as Killip grade III-IV or LVEF <35%; Coronary artery bypass grafting within the past 3 years or planned; The patient is using or planning to use long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed); Patients with severe liver and kidney disease; Patients with a history of cancer or lymphoproliferative diseases in the past 3 years; Implanted metal in the body or claustrophobia cannot accept cardiac MRI; Pregnancy or breastfeeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ming Cui, Doctor
    Phone
    +8615611908487
    Email
    mingcui@bjmu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Penguin Xie, master
    Phone
    +8618810793282
    Email
    xiepengxin2014@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ming Cui, Doctor
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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