Dapagliflozin in STEMI (DAPA STEMI)

University of Ottawa Heart Institute

Status and phase: Enrolling; Phase 3

Conditions: ST Elevation Myocardial Infarction; Myocardial Infarction

Treatments: Drug: Dapagliflozin 10mg Tab; Diagnostic Test: CMR

Study type: Interventional

Funder types: Other

Identifiers

NCT06174753

20230332-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Ischemic chest discomfort of ≥30 minutes duration, and

• Onset of chest pain ≤12 hours prior to entry into the study, and

• 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

• Age < 18 years
• Any contraindication to undergo CMR imaging
• Killip 4 (Cardiogenic shock on presentation)
• Therapy with SGLT2i within last 8 weeks
• Type 1 diabetes mellitus
• Pregnancy
• Nursing mother
• Unwilling to use appropriate forms of contraception, as applicable
• Chronic symptomatic HF with prior hospitalization for HF within the last year
• hospitalization
• Known history of prior MI
• Any non-CV condition with a life expectancy of less than one year
• Previous randomization in the present study
• Participation in a study with another investigational device or drug < four weeks
• Inability to provide informed consent
• Confirmed ketoacidosis at time of admission
• Known severe hepatic impairment (Cirrhosis)
• Severe renal impairment (eGFR < 30 mL/min1.73m2 (based on prior or baseline blood work)
• Known severe valvular heart disease
• Need for CABG within 90 days based on the results of the initial coronary angiogram
• False positive STEMI (based on the results of the coronary angiogram)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Dapagliflozin 10mg daily X 7 days

Treatment:

Diagnostic Test: CMR

Drug: Dapagliflozin 10mg Tab

Placebo

Placebo Comparator group

Description:

Placebo daily X 7 days

Treatment:

Diagnostic Test: CMR