ST-segment Elevation Myocardial Infarction (STEMI)Phase 4NCT05511831
The Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI
A Phase 4 study testing Ketotifen Fumarate and standard treatment in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Ketotifen Fumarate and standard treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Study on the Efficacy and Safety of Ketotifen in Primary PCI Patients With 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.
Read the 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.
- Being tested
- Ketotifen Fumarate, standard treatment
- Keywords
- ketotifen, STEMI, mast cell, prognosis
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketotifen FumarateDrug
Also called Ketotifen
Ketotifen treatment for 3 months, 1 mg each time, 1-2 times a day according to the patient's tolerance
Also called standard
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.
| Study group | Role | What they receive |
|---|---|---|
| ketotifen | Experimental | 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. Receives: Drug: Ketotifen Fumarate |
| Control group | Sham comparator | Standard treatment according to guidelines Receives: Drug: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size
Myocardial infarct size was assessed by cardiac MRI
Measured: 3 months after myocardial infarction
Secondary outcomes (5)
left ventricular systolic function
Transthoracic echocardiography to measure LVEF, left ventricular end-diastolic diameter, Em/Sm
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
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
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory factors and MC markers
Analysis of inflammatory factors (such as TNF-α, IL1, IL6, etc.) and MC markers (chymotrypsin)
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
major adverse cardiovascular events
MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)
Measured: 12 months
Drug-Related Adverse Reactions
Fatigue, lethargy and lethargy, nausea and other gastrointestinal adverse reactions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Cui, Doctor, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511831
- Sponsor's protocol ID
- M2022319
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI
- ClinicalTrials.gov ID
- NCT05511831
- Acronym / sponsor ID
- M2022319
- Keywords
- ketotifen, STEMI, mast cell, prognosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketotifen | Experimental | Drug: Ketotifen FumarateKetotifen 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 comparator | Drug: standard treatmentStandard treatment according to guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketotifen FumarateAlso: KetotifenKetotifen treatment for 3 months, 1 mg each time, 1-2 times a day according to the patient's tolerance | Drug | ketotifen |
| standard treatmentAlso: standardStandard 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. | Drug | Control group |
Primary outcome
Myocardial infarct size
Time frame: 3 months after myocardial infarction
Myocardial infarct size was assessed by cardiac MRI
5 secondary outcomes
left ventricular systolic function
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Left ventricular ultrasound strain
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory factors and MC markers
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
major adverse cardiovascular events
Time frame: 12 months
Drug-Related Adverse Reactions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Cui, Doctor study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketotifen Fumarate and standard treatment in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Cui, Doctor (+8615611908487, mingcui@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarct size (time frame: 3 months after myocardial infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.