GLP-1RAs) and SGLT2is Combination Therapy and MACEs in Patients with Type 2 Diabetes.
NCT06017544 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 257
Last updated 2025-01-20
Summary
Management of type 2 diabetes mellitus (T2DM) has evolved from a glucocentric to a cardiometabolic approach. Both glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2is) reduce cardiovascular and kidney outcomes in T2DM patients with a low hypoglycemia risk. The T2DM di per se still carries a higher risk of mortality and major cardiovascular complications, doubling the case fatality rate. Tacking that GLP-1RAs and SGLT2is have different mechanisms of action, resulting in complementary pharmacokinetics and pharmacodynamics, the combination use may present clinical efficacy and safety in T2DM patients with AMI. However, there is limited clinical evidence that supports the combined use of these drugs, and there are currently no studies investigating the effects of combination treatment in T2DM patients with acute cardiovascular events, on MACE as well as on myocardial post-infarction rescue. Therefore, authors will conduct an observational prospective study to evaluate the effects GLP-1RAs and SGLT2is combination therapy on MACE such as mortality, acute coronary syndrome and heart failure, and myocardial salvage index (MSI) after acute myocardial infarction (AMI) in T2DM patients.
Conditions
- Diabetes Mellitus, Type 2
- Myocardial Infarction
Interventions
- PROCEDURE
-
PCI
The T2DM affected by AMI will be referred for receiving PCI.
Sponsors & Collaborators
-
University of Campania Luigi Vanvitelli
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-01
- Primary Completion
- 2024-06-01
- Completion
- 2024-12-01
Countries
- Italy
Study Locations
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