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
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
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
NCT ID
NCT05511831
First Posted
August 19, 2022
Last Updated
August 22, 2022
Sponsor
Peking University Third Hospital
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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The Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI
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