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Empagliflozin to Prevent Post-Operative Atrial Fibrillation

NCT06124937 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2023-11-22

No results posted yet for this study

Summary

This is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. The goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2I), can reduce the incidence of post-operative atrial fibrillation and/or atrial flutter in patients with chronic coronary syndrome scheduled for isolated CABG. This trial will be conducted in two referral teaching cardiology hospitals in Tehran. 492 adult patients who are scheduled for elective isolated coronary artery bypass graft (CABG) surgery will be randomly assigned to one of the groups of intervention (empagliflozin 10 mg daily) or placebo starting 3 days before surgery until discharge.

Conditions

  • Post-operative Atrial Fibrillation
  • CABG

Interventions

DRUG

Empagliflozin 10 MG

The intervention group will receive a 10 mg tablet of empagliflozin once a day from 3 days before surgery until discharge from the hospital.

DRUG

Placebo

The comparator group will receive a matching placebo from 3 days before surgery until discharge from the hospital.

Sponsors & Collaborators

  • Tehran Heart Center

    collaborator OTHER

  • Rajaie Cardiovascular Medical and Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124937 on ClinicalTrials.gov