NCT06017544Completed
GLP-1RAs) and SGLT2is Combination Therapy and MACEs in Patients with Type 2 Diabetes.
Glucagon-like Peptide-1 Receptor Agonists (GLP-1RAs) and Sodium-glucose Cotransporter-2 Inhibitors (SGLT2is) Combination Therapy and Major Adverse Cardiovascular Events After Acute Myocardial Infarction: an Observational Study in Patients with Type 2 Diabetes.
Source: ClinicalTrials.gov · Last updated 20 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 257 (actual)
- First submitted
- 24 Aug 2023
- Start date
- 1 Jan 2017
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Diseases
- Coronary artery disease, Type 2 diabetes
- NCT number
- NCT06017544
What you commit to
- Study type: Observational
- Participants enrolled: 257
- From 1 Jan 2017 to the primary completion date, 1 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- heart failure and valvular defects;
- inflammatory chronic diseases;
- neoplastic diseases.
Who the study is looking for
- Consecutive T2DM patients, treated with GLP-1 RA or SGLT-2i, with AMI;
- both STEMI and NSTEMI patients referred for PCI;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Celestino Sardu Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.