Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI)

Sponsor
Instituto Mexicano del Seguro Social
Study ID
NCT04717986
Status
Completed

Conditions

  • Acute Myocardial Infarction
  • Angina, Unstable
  • Cardiovascular Morbidity
  • Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    patients who meet the inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 12 months
  • Placebo — DRUG
    patients meeting the inclusion criteria will be randomized to receive a placebo solution every 24 hours for 12 months

Study Details

The actual evidence is solid about the use of de SGLT2-inhibitors in wide spectrum of cardiorenal targets, which has been shown in a great amount of randomized clinical trials compared with placebo. At present it must be taken into account as first line treatment in patients with DM2, even their security profile has allowed the use in patients without diagnosis of DM2, since they have be shown a beneficial cardioprotect effects. Most studies support they use in patients with high cardiovascular risk, nevertheless, their use in patients with recent diagnosis of ischemic hearth disease its limited, being the latter entity the most frequent etiology found in patients who develop chronic hearth failure either as part of heart attack or unstable angina.

Key Dates

Start date
Jan 26, 2021
Status verified
Jun 2023
Primary completion
Jun 30, 2022
Completion
Jun 20, 2023

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    Dapagliflozin 10 mg every 24 hours for 12 months
  • Placebo Comparator: Control Group
    1 placebo tablet every 24 hours for 12 months

Primary Outcome Measure

Mayor adverse cardiovascular effects [ Time Frame: 12 months ]

Related Studies