Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury

NCT05435235 | Suspended Phase 4 DMC FDA Drug

• 1 other identifier: 2022-864
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.

Conditions

Acute Kidney Injury; Percutaneous Coronary Intervention

Keywords

SGLT2 inhibitor; Dapagliflozin; AKI; PCI; Angiography

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  According to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 definition: increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline which is known or presumed to have occurred within the prior 7 days. We will measure Urine Neutrophil Gelatinase-associated Lipocalin (UNGAL) at least 6 hours post-PCI and Serum Creatinine at follow up within 7 days.

  Within 7 days.

Secondary Outcomes (2)

• Length of hospital stay

  7 days

• Incidence of genitourinary infections

  7 days

Study Arms (2)

Dapagliflozin arm

EXPERIMENTAL

Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.

Drug: Dapagliflozin 10mg Tab

Standard of care

NO INTERVENTION

Patients who received the standard of care.

Interventions

Dapagliflozin 10mg Tab DRUG

One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.

Dapagliflozin arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or more.
• Scheduled/non-emergent Percutaneous coronary intervention (PCI).
• Post-index procedure Staged PCI with at least 14 days from contrast exposure.
• Patient can fully understand the study information and sign informed consent.

You may not qualify if:

• Cardiogenic shock /need for inotrope or mechanical pump support.
• Acute kidney injury as defined by KDIGO criteria (\<4 weeks) prior to PCI.
• End-Stage Renal Disease prior to PCI (On renal replacement therapy).
• Diabetes Mellitus type 1.
• Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose \>400 mg/dl).
• ST-segment elevation Myocardial Infarction undergoing index PCI.
• Active Genitourinary infection.
• Diagnostic Left Heart Catheterization without PCI.
• Patients undergoing zero contrast PCI.
• Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
• Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
• Patients with Acute Heart Failure admission \< 30 days prior to PCI.
• Intercurrent illness resulting in volume depletion and hypotension (MAP\<60 mmHg).
• Patients with a kidney transplant.
• Any contrast exposure within 14 days.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist and Director of Academics, Cardiology

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 28, 2022
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)