Status:
UNKNOWN
Cardioprotective Effect of SGLT2-I in Diabetic Patients With AMI (SGLT2-I AMI PROTECT Study)
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
Maggiore Hospital Carlo Alberto Pizzardi
VZW Cardiovascular Research Center Aalst
Conditions:
Diabetes Mellitus
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
Despite their potential benefits on the heart with pleiotropic mechanisms, the cardioprotective effects of new glucose-lowering SGLT-2 inhibitors in patients with myocardial infarction - both in the a...
Detailed Description
Classically, the physiopathology of myocardial infarction is linked to the presence of coronary atherosclerosis. According to the European Society of Cardiology (ESC)/American College of Cardiology (A...
Eligibility Criteria
Inclusion
- Age ≥18 y old
- STEMI/NSTEMI diagnosed according to ESC guidelines undergoing reperfusion treatment with percutaneous transluminal coronary angioplasty (PTCA).
- Known type II diabetes mellitus treated with oral antidiabetic drugs
Exclusion
- Type I diabetes mellitus or type II diabetes mellitus treated only with insulin therapy alone or in combination with other anti-diabetic drugs.
- Patients treated with Coronary artery bypass grafting (CABG) after the coronary angiography (CAG) (NSTEMI)
- Previous CABG
- Severe valvular heart disease.
- Contraindications for secondary medical prevention therapy approved for myocardial infarctions, like beta-blockers, angiotensin-converting enzyme inhibitor(ACEI )/angiotensin receptor blocker (ARBs), antiplatelets, statins. All patients will be treated with optimal secondary prevention therapy suggested by the current ESC guidelines.
- Patients who start SGLT2 therapy after the acute index event.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05261867
Start Date
January 1 2017
End Date
January 1 2023
Last Update
October 24 2022
Active Locations (7)
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1
Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium
Aalst, Belgium, 9300
2
Alexandrovska University Hospital, Sofia, Bulgaria
Sofia, Bulgaria
3
Policlinico Sant'Orsola
Bologna, Italy
4
Azienda Ospedaliera Sant'Anna e San Sebastiano, Caserta
Caserta, Italy