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Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial)

RecruitingPhase 3Ages 18 Years - anyAllInstituto Mexicano del Seguro Social
NCT07295223 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The primary risk factor for coronary artery disease is atherosclerosis, with inflammation playing a crucial role in the development and progression of this condition. It has now been proven that inflammation is key in the development of complications after an acute myocardial infarction. These complications can be immediate and mechanical, such as ventricular wall rupture and ventricular arrhythmia, or long-term, presenting as major cardiovascular events like heart failure. During acute myocardial infarction (AMI), circulating high-sensitivity CRP levels increase approximately 6 hours after the onset of ischemia. CRP levels measured between 24 and 72 hours after symptom onset are a significant prognostic marker for one-year outcomes. Higher high-sensitivity CRP levels at the time of AMI are linked to more severe coronary atherosclerotic lesions seen on angiography and lower LVEF one mon

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📋 Eligibility rules (as published)
Inclusion Criteria: * Criteria for the fourth definition of acute myocardial infarction with ST-segment elevation. * Diagnosed with type 2 diabetes. * Initial serum high-sensitivity CRP value \> 2.0 mg/L. * Clinically obese. * LVEF \>50%. Exclusion Criteria: * Patients who have recently received immunosuppressive therapy * Patients with a history of ischemic heart disease * Known allergy to any of the medications used * Use of any of the study drugs more than 6 months prior to randomization * Patients experiencing diabetic ketoacidosis * Patients with hemodynamic instability (mean arterial pressure \<60 mmHg while on vasopressors) * Pregnant women * Patients with a history or current diagnosis of cancer * Patients with documented active infections, such as pneumonia or urinary tract infections * Patients with pancreatitis
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What it tests

  • Dapagliflozin 10 MG Oral Tablet
  • Semaglutide (Rybelsus®)
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Where

1 site
Hospital de Especialidades No.1, Centro Médico Nacional del Bajío
León, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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