Status:
UNKNOWN
The POST-ACS Study
Lead Sponsor:
Swansea Bay University Health Board
Conditions:
Diabetes Mellitus
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Individuals with T2DM have a two-fold excess risk of cardiovascular (CV) events compared with their non-diabetic counterparts. Although it is the primary cause of death in T2DM, there is no significa...
Eligibility Criteria
Inclusion
- HbA1c \> 5.7% (39 mmol/mol)
- Patients presented with a clinical diagnosis of ACS comprising detection of a rise and/or fall of cardiac troponin (cTn) with at least one value above the 99th percentile and with at least one of the following:
- Symptoms of acute myocardial ischemia;
- New ischemic electrocardiographic (ECG) changes (ST-T wave changes or new LBBB);
- Development of pathological Q waves;
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic aetiology;
- Identification of a coronary thrombus by angiography including intracoronary imaging or by autopsy
Exclusion
- Type 1 DM
- Left ventricular ejection fraction \<40%
- Heart failure classified as being in New York Heart Association (NYHA) Class III-IV.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation.
- History of renal insufficiency with estimated glomerular filtration rate \<30mL/min/1.73m2
- A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- History of treatment with GLP-1 within 90 days before screening
- Current use of SGLT-2 inhibitors within 30 days of screening
- Known or suspected hypersensitivity to Semaglutide or related products.
- Female who is pregnant, breastfeeding or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
- Current enrolment in any other clinical trial within 30 days from screening
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05322200
Start Date
August 31 2022
End Date
August 1 2024
Last Update
October 27 2022
Active Locations (1)
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1
Swansea Bay University Health Board
Swansea, United Kingdom, SA2 8QA