Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Men and women aged ≥ 18 years (women of childbearing age must have a negative pregnancy test);

• In routine use of dual antiplatelet therapy with ASA plus an ADP receptor antagonist, according to institutional routines;

• Acute myocardial infarction, with or without ST-segment elevation (STEMI/NSTEMI) defined according to the 4th Universal Definition of Acute Myocardial Infarction, with up to 7 days of evolution from the onset of symptoms;

• Signature of the Free and Informed Consent Term.

Locations
Other Locations
Brazil
Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Jose JN Nicolau
jose.nicolau@incor.usp.br
+55 (11) 2661-5058
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 80
Treatments
Experimental: Dapagliflozin
Dapagliflozin 10 mg tablets given once daily, per oral use
Placebo_comparator: Placebo group
Placebo tablets given once daily, per oral use
Sponsors
Leads: University of Sao Paulo

This content was sourced from clinicaltrials.gov

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