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SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF

Study acronym: STENOTYPE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 7 to 8
    • Collaborators: 12 to 13
    v3
  2. Phase: Phase 4 to Phase 3v2 Show 9 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 2, 2025 to Dec 4, 2027
    • Start date changed from estimate of Oct 2, 2023 to Apr 4, 2024
    • Study sites: 0 to 7
    • Study completion date: Oct 2, 2026 to Dec 4, 2028
    • Eligibility criteria expanded, about 229 words
    • Secondary endpoints: 17 to 18
    • Study description shortened, about 320 words
    • Collaborators revised (12)
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized, double-blinded, controlled clinical trial is to investigate if treatment with an sodium-glucose cotransporter-2 inhibitor (SGLT2) during the unique time window before coronary artery bypass surgery (CABG), can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury in patients with chronic coronary syndrome. The main questions it aims to answer are: * Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of new onset atrial fibrillation compared to placebo? * Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of acute kidney injury before hospital discharge compared to placebo? Participants will be administered dapagliflozin 10 mg once daily or placebo for a minimum of seven days while awaiting scheduled CABG and up until discharge, with a short interruption for surgery. The active arm will be compared to the placebo arm to see if dapagliflozin can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury.
Trial Details
NCT Number NCT05852704
Lead Sponsor Region Örebro County
Collaborators: Odense University Hospital, Aarhus University Hospital, Örebro University, Sweden, Sahlgrenska University Hospital, Göteborg University, University of Leeds, Skane University Hospital, London School of Hygiene and Tropical Medicine, St. Anne's University Hospital Brno, Czech Republic, Mount Sinai Hospital, New York, Icahn School of Medicine at Mount Sinai, University Hospital, Linkoeping, Rigshospitalet, Denmark
Conditions
(from sponsor)		 Chronic Coronary Syndrome, Atrial Fibrillation
Related terms Acute Kidney Injury, Atrial Fibrillation
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov