The efficacy of dapagliflozin in preventing contrast-associated acute kidney injury
Phase 3
Recruiting
- Conditions
- Acute Coronary Syndrome.ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
- Registration Number
- IRCT20181026041471N1
- Lead Sponsor
- Rajaie Cardiovascular Medical and Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
Patients over 18 years old hospitalized with acute coronary syndrome (i.e. ST elevation or NST elevation myocardial infarction or unstable angina) diagnosis and candidates for coronary angiography or angioplasty
Signed informed consent to participate in the study
Exclusion Criteria
Patients previously treated with SGLT2 inhibitor drugs
Creatinine clearance less than 25 ml/min
Chronic liver disease and cirrhosis (Child-Pugh C)
Drug allergy or history of severe hypersensitivity to dapagliflozin or its components
Non-consent to participate in the study
History of recurrent urinary tract infections
History of ketoacidosis
Pregnancy or breastfeeding
Type 1 diabetes mellitus
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?The incidence of contrast- associated acute kidney injury defined by KDIGO criteria . Timepoint: 7 days after intervention. Method of measurement: Lab findings (serum creatinine) and urine output.
- Secondary Outcome Measures
Name Time Method eed for renal replacement therapy. Timepoint: 7 days? after intervention. Method of measurement: Clinical records.;Length of hospitalization. Timepoint: Until discharge from hospital. Method of measurement: Clinical records.;Incidence of adverse drug reactions. Timepoint: 7 days after randomization. Method of measurement: Clinical records.