The Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI
A Randomized Controlled Study on the Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2022
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2022
CompletedFirst Posted
Study publicly available on registry
August 23, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 23, 2022
August 1, 2022
1.3 years
August 19, 2022
August 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial infarct size
Myocardial infarct size was assessed by cardiac MRI
3 months after myocardial infarction
Secondary Outcomes (5)
left ventricular systolic function
24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Left ventricular ultrasound strain
24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory factors and MC markers
24 hours, 1 month, 3 months, and 12 months after myocardial infarction
major adverse cardiovascular events
12 months
Drug-Related Adverse Reactions
12 months
Study Arms (2)
ketotifen
EXPERIMENTALKetotifen 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.
Control group
SHAM COMPARATORStandard treatment according to guidelines
Interventions
Ketotifen treatment for 3 months, 1 mg each time, 1-2 times a day according to the patient's tolerance
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ming Cui, Doctor
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2022
First Posted
August 23, 2022
Study Start
September 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
August 23, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share