Dapagliflozin in STEMI Randomized Clinical Trial

Myocardial Infarction Clinical Trial

— DAPA STEMI  

Official title:

THE UNIVERSITY of OTTAWA DAPAGLIFLOZIN in STEMI RANDOMIZED CLINICAL TRIAL

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174753
• Other study ID #: 20230332-01H
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2024
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Poppy MacPhee, BScN
• Phone: 6136967000
• Email: pmacphee[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the safety and efficacy of SGLT2i in limiting infarct size in patients with STEMI referred for PPCI. Eligible STEMI patients enrolled into the trial will be randomized to a SGLT2i or placebo. Cardiovascular Magnetic Resonance (CMR) imaging will be used to determine the infarct size.

Description:

DAPA STEMI is a single center, randomized, double-blind, parallel group study in which eligible participants with a STEMI and undergoing PPCI will be recruited and randomly assigned to dapagliflozin or placebo to take for 7 days. Participants will be prescribed study treatment i.e. dapagliflozin (10 mg) or placebo daily for 7 days. A CMR will be obtained at day 3-5 to assess for infarct size. Participants will have follow-up visits at 30, 90, and 180 days to assess for cardiovascular events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: September 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients referred for PPCI meeting the following criteria are eligible for the study:

1. Ischemic chest discomfort of =30 minutes duration, and

2. Onset of chest pain =12 hours prior to entry into the study, and

3. One of the following High-Risk criteria on a standard 12 lead ECG:

a. Anterior STEMI with ST-segment elevation =2mm (0.2 mV) in each of at least 2 contiguous precordial leads (V1-V6) b. Extensive non-anterior STEMI defined as ST-segment elevation of >1mm in two or more contiguous non-anterior leads accompanied by i. 8 or more leads with > 1 mm ST elevation or depression, or both; OR ii. Sum of ST- segment elevation >20mm

Exclusion Criteria:

• 1. Age < 18 years 2. Any contraindication to undergo CMR imaging 3. Killip 4 (Cardiogenic shock on presentation) 4. Therapy with SGLT2i within last 8 weeks 5. Type 1 diabetes mellitus 6. Pregnancy 7. Nursing mother 8. Unwilling to use appropriate forms of contraception, as applicable 9. Chronic symptomatic HF with prior hospitalization for HF within the last year 10. Known LVEF <40% by any prior measure, documented before the current MI hospitalization 11. Known history of prior MI 12. Any non-CV condition with a life expectancy of less than one year 13. Previous randomization in the present study 14. Participation in a study with another investigational device or drug < four weeks 15. Inability to provide informed consent

16. Confirmed ketoacidosis at time of admission 17. Known severe hepatic impairment (Cirrhosis) 18. Severe renal impairment (eGFR < 30 mL/min1.73m2 (based on prior or baseline blood work) 19. Known severe valvular heart disease 20. Need for CABG within 90 days based on the results of the initial coronary angiogram 21. False positive STEMI (based on the results of the coronary angiogram)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Dapagliflozin 10mg Tab
Dapagliflozin 10 mg daily X 7 days

Diagnostic Test:
• CMR
CMR 3-5 days post randomization

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct Size	Infarct size (% of total LV mass) measured by CMR	3-5 days
Secondary	Multiple Cardiac Adverse Events (MACE)	A composite of death, reinfarction, stroke, or rehospitalization for HF	3 months, and 6 months
Secondary	Cardiogenic Shock	Evaluated using the SCAI classification; only class C, D, or E will be adjudicated as a secondary outcome	during initial hospitalization
Secondary	Acute Kidney Injury	As defined according to the KDIGO definition	3 months, and 6 months