DAPA-MI is a result of collaboration between the study sponsor AstraZeneca and Uppsala Clinical Research Center.
The DAPA-MI study will evaluate the effect of dapagliflozin (Forxiga/Farxiga), given once daily in addition to Standard of Care therapies for patients with myocardial infarction, but without known diabetes, for the prevention of hospitalization for heart failure or cardiovascular death. This is a double-blind registry-based randomized placebo-controlled trial, R-RCT. The innovative indication-seeking trial will recruit around 6,400 patients from approximately 50 hospitals in Sweden and 50 hospitals the UK. In addition, the trial is using digital technologies to promote patient engagement and study drug adherence.
Prospective data collection is done through two national cardiovascular disease quality registries, SWEDEHEART, hosted by UCR in Sweden and MINAP, hosted by NICOR (National Institute for Cardiovascular Outcomes Research) in the UK. This is possible due to a long standing collaboration between UCR and NICOR with MINAP being built on UCRs registry platform QReg5. UCR is a nationally and internationally leading non-profit academic research organization with expertise and broad experience within R-RCT.
Innovative components in DAPA-MI trial
- Use of quality registers from clinical routine will accelerate and expand patient recruitment,
National data will cover the entire population in Sweden, Wales and England through a shared technical platform.
- Streamlined trial design with automated data transfer from routine practice will reduce patient and investigator burden. Data is prospectively collected at the point-of-care.
- A mobile phone device App for information sharing and signaling of events will allow remote patient monitoring. The patient will be asked regularly if he / she has been hospitalized due to heart failure. The patient can also read about cardiovascular disease and medications in the App. Patients will be offered to receive reminders when it's time to visit the clinic.
- Use of CleverCap Lite bottle caps technology will allow “real time” monitoring of study drug adherence, and opportunity for the Investigator to follow up on patterns of irregular or low adherence.
Myocardial infarction (MI) affects more than 7 million individuals each year. Previously observed improvements in post MI prognosis have reached a plateau in recent years. Novel approaches need to tackle post MI heart failure development which is the strongest predictor of mortality. Due to its mode of action, dapagliflozin is hypothesized to reduce the risk for development of heart failure following MI.
Dapagliflozin may be a relevant pharmacological addition for the treatment of MI, where new therapies have not emerged in over a decade.