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The efficacy of dapagliflozin in preventing contrast-associated acute kidney injury

Evaluating the effect of dapagliflozin on preventing contrast-associated acute kidney injury in patients with acute coronary syndrome undergoing angiography (DARIUS); a multicenter, randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181026041471N1
Enrollment
1500
Registered
2024-08-20
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome. ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Interventions

Intervention 1: Patients in the intervention group will receive 20 mg of dapagliflozin immediately after randomization and before entering the cath lab, followed by 10 mg daily for a minimum of 48 hou

Sponsors

Rajaie Cardiovascular Medical and Research Institute
Lead Sponsor
Tehran University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
?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

MeasureTime frame
Need 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHessam kakavand

Iran University of Medical Sciences

hessamkakavand@yahoo.com+98 21 23921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026