Dapagliflozin for Heart Attack

(DAPA STEMI Trial)

Overseen By Poppy MacPhee, BScN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: SGLT2i

Disqualifiers: Type 1 diabetes, Pregnancy, Severe renal impairment, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Dapagliflozin, a medication, can reduce heart damage after a severe heart attack, known as STEMI. Researchers aim to determine if this drug can safely limit heart damage in individuals undergoing a procedure called PPCI to restore blood flow. Participants will receive either the medication or a placebo (a pill with no active drug) for seven days. The trial seeks individuals who have experienced chest pain for at least 30 minutes and meet specific heart test criteria. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking heart attack treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have used SGLT2 inhibitors in the last 8 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dapagliflozin, the drug being tested in this trial, has been studied in other cases. In patients with heart failure, dapagliflozin reduced the risk of dying from heart-related issues by 14%. Another study found that it improved heart health in people who had a heart attack, even if they didn't have diabetes.

These studies suggest that dapagliflozin is generally well-tolerated, meaning most people don't experience serious side effects. However, individual responses can vary, and some might experience side effects. It's important to discuss any personal health concerns with a doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart attack?

Researchers are excited about dapagliflozin for heart attack treatment because it offers a novel approach by targeting the sodium-glucose co-transporter 2 (SGLT2). Unlike traditional heart attack treatments that often focus on blood flow and clot prevention, dapagliflozin helps to reduce heart strain by promoting glucose excretion and potentially improving heart function. This drug, initially used for diabetes management, has shown promise in heart health, making it a unique option for quick recovery post-heart attack. Its potential to deliver significant benefits in just seven days sets it apart from many standard treatments that typically take longer to show results.

What evidence suggests that dapagliflozin might be an effective treatment for heart attack?

In this trial, participants will receive either dapagliflozin or a placebo. Research has shown that dapagliflozin can aid heart conditions. Studies have found that it significantly reduces the risk of heart problems compared to a placebo. Specifically, one study showed it lowers the risk of dying from heart-related issues by 14% over about two years. Dapagliflozin also eases heart failure symptoms after a heart attack, even in people without diabetes. These findings suggest that dapagliflozin could help limit damage after a heart attack, making it a promising treatment option. ^{1 2 3 4 5}

Who Is on the Research Team?

Michel LeMay, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for patients who have had a severe type of heart attack known as STEMI and are going to undergo primary percutaneous coronary intervention (PPCI). The specific details about who can join or must avoid the trial aren't provided here.

Inclusion Criteria

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

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

I have had chest pain lasting 30 minutes or more.

Exclusion Criteria

I am under 18 years old.

Previous randomization in the present study

Confirmed ketoacidosis at time of admission

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive dapagliflozin or placebo daily for 7 days

1 week

Daily administration

Initial Assessment

Cardiovascular Magnetic Resonance (CMR) imaging to assess infarct size

3-5 days

1 visit (in-person)

Follow-up

Participants are monitored for cardiovascular events and other outcomes

6 months

3 visits (in-person) at 30, 90, and 180 days

What Are the Treatments Tested in This Trial?

Interventions

• CMR
• Dapagliflozin

Trial Overview The study is testing if a diabetes medication called Dapagliflozin can reduce the damage to the heart muscle in patients with STEMI. Participants will be randomly assigned to receive either Dapagliflozin or a placebo, alongside their standard treatment.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 Interventions

Dapagliflozin 10mg daily X 7 days

Group II: Placebo Placebo Group 2 Interventions

Placebo daily X 7 days

Dapagliflozin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Forxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in United States as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in Canada as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

Dapagliflozin is an effective treatment for type 2 diabetes, proven through multiple controlled clinical trials that assess its efficacy, safety, and tolerability.

It is approved by the FDA for use as a standalone therapy or in combination with other glucose-lowering medications, including insulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. Davis, PN., Ndefo, UA., Oliver, A.[2021]

Dapagliflozin (DAPA) is an effective SGLT2 inhibitor for treating type 2 diabetes, showing favorable pharmacokinetics and pharmacodynamics that help lower blood sugar levels while having beneficial effects on other metabolic risk factors.

While DAPA is generally safe, it carries an increased risk of genital and urinary infections, and concerns about bladder cancer and cardiovascular safety remain, prompting the FDA to seek further data on these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. Maranghi, M., Carnovale, A., Durante, C., et al.[2021]

Dapagliflozin effectively lowers blood sugar levels and glycated hemoglobin (HbA1c) in patients with type 2 diabetes, with a low risk of hypoglycemia and additional benefits like weight loss and reduced blood pressure.

While it is generally safe, dapagliflozin can increase the risk of genital infections, particularly in women, and its efficacy may be reduced in patients with kidney issues; ongoing trials are investigating its potential cardiovascular and renal protective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. Scheen, AJ.[2021]

Dapagliflozin (Farxiga) is approved for reducing the risk of declining kidney function and kidney failure in adults with chronic kidney disease, regardless of whether they have type 2 diabetes.

It also helps lower the risk of cardiovascular death and hospitalization for heart failure, highlighting its efficacy in managing both kidney and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. Aschenbrenner, DS.[2023]

Dapagliflozin, an SGLT2 inhibitor, has been shown to significantly reduce the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF), regardless of whether they have type 2 diabetes.

In the DAPA-HF trial, dapagliflozin was well tolerated and demonstrated a lower risk of worsening heart failure or cardiovascular death compared to placebo, making it a valuable treatment option for adults with symptomatic HFrEF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction. Blair, HA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11364978/

Dapagliflozin in Heart Failure and Acute Myocardial Infarction In the study, treatment with dapagliflozin resulted in a significantly lower incidence of the primary outcome compared to placebo (16.3% vs.

2. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2300286

Dapagliflozin in Myocardial Infarction without Diabetes or ... We studied the effect of 10 mg of dapagliflozin once daily on a broad range of cardiometabolic outcomes when added to standard of care in patients hospitalized ...

3. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2022/farxiga-lowers-risk-cv-death-heart-failure.html

New data show Farxiga significantly lowers the risk of ... The analysis showed that Farxiga reduced the risk of CV death by 14% (p=0.01, absolute risk reduction [ARR] 1.5%) over the median follow-up of 22 months.

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.040327

Subanalyses of the DAPA‐MI Trial Dapagliflozin reduced the development of heart failure symptoms following myocardial infarction in individuals without diabetes or chronic heart ...

5. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2022/new-data-show-farxiga-significantly-lowers-the-risk-of-cardiovascular-death-in-patients-with-heart-failure.html

New data show FARXIGA significantly lowers the risk of ... The analysis showed that FARXIGA reduced the risk of CV death by 14% (p=0.01, absolute risk reduction [ARR] 1.5%) over the median follow-up of ...