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A Multicenter, Randomized, Placebo-Controlled Study on the Efficacy and Safety of Ketotifen in Patients With ST-Segment Elevation Myocardial Infarction

A Multicenter, Randomized, Placebo-Controlled Study on the Efficacy and Safety of Ketotifen in Patients With ST-Segment Elevation Myocardial Infarction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114700
Enrollment
Unknown
Registered
2025-12-16
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-Segment Elevation Myocardial Infarction

Interventions

Control Group:Starch placebo
Ketotifen Group:Ketotifen 1mg, twice a day

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 or older, any gender; 2. Meeting the diagnostic criteria for STEMI (diagnostic criteria: ischemic chest pain lasting =30 minutes; ST-segment elevation in two or more contiguous leads on ECG or new-onset left bundle branch block; with or without elevated myocardial biomarkers); 3. Diagnosis of STEMI within the past 7 days; 4. Receiving standard treatment as recommended by the "Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction (2019)", including dual antiplatelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers/angiotensin receptor-neprilysin inhibitors (ACEI/ARB/ARNI), ß-blockers, statins, and PCI, etc.; 5. Agree to participate and cooperate in this study.

Exclusion criteria

Exclusion criteria: 1.Severe heart failure, such as Killip class IV or LVEF 3× the upper limit of normal; GFR <30 mL/min/1.72 m^2); 5.History of cancer or lymphoproliferative disorders within the past 3 years; 6.Current autoimmune disease, allergic disease, or asthma; 7.Contraindication to ketotifen use, including allergy to the drug or concurrent use of central nervous system depressants; 8.Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Major adverse cardiovascular events;

Secondary

MeasureTime frame
high-sensitivity C-reactive protein;Major adverse cardiovascular and cerebrovascular events;Left ventricular ejection fraction;Adverse drug reaction events;

Countries

China

Contacts

Public ContactMing Cui

Peking University Third Hospital

mingcui@bjmu.edu.cn+86 10 82266699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026