Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Sponsor
University of Sao Paulo
Study ID
NCT06286878
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Acute Coronary Syndrome
  • Diabetes
  • Myocardial Infarction
  • Ventricular Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Patients will be randomized to use dapagliflozin or placebo in a double-blind way
  • Dapagliflozin — DRUG
    Patients will be randomized to use dapagliflozin or placebo in a double-blind way

Study Details

Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for atherosclerotic heart disease. Strategies focused solely on glycemic control have failed to demonstrate vascular events reduction in this population. On the other hand, new antidiabetic drugs recently have demonstrated significant decrease of cardiovascular mortality, raising the hypothesis that possible effects beyond glycemia control could explain this benefit. Aim: This study is intended to evaluate possible pleiothropic effects of dapaglifozin, a SGLT-2 (sodium glucose cotransporter 2) inhibitor, in individuals admitted with a diagnosis of Acute Myocardial Infarction (AMI). Methods: This is a prospective, randomized, double-blind, placebo controlled trial. Individuals presenting with AMI whithin the first seven days of evolution will be randomized to dapaglifozin or placebo. The investigators's goal is to analyze platelet aggregability 48 hours after randomization (primary endpoint), as well as glycemic control, cardiac biomarkers, corrected QT interval electrocardiographic analysis, autonomic modulation through spectral analysis of the RR interval and inflammatory biomarkers at inclusion and 30 days after starting study drug (secondary endpoints). Sample size calculation resulted in 80 individuals (40 per group). Expected results: This study will seek to aggregate new insights to the current knowledge about this new antidiabetic drug class. Previous randomized clinical trials have demonstrated that SGLT-2 inhibitors significantly reduced the composite endpoint of cardiovascular death, AMI or stroke, as well as Heart Failure (HF) hospitalization. Therefore, this study is supposed to clarify possible mechanisms that could explain these results aforementioned.

Key Dates

Start date
Dec 8, 2021
Status verified
Feb 2025
Primary completion
Jul 30, 2025
Completion
Jul 30, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg tablets given once daily, per oral use
  • Placebo Comparator: Placebo group
    Placebo tablets given once daily, per oral use

Primary Outcome Measure

Platelet aggregation using ADP [ Time Frame: 4 Years ]

Central Contacts

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