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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Treatments: Ketotifen

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.