Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury (DAPA-PCI-AKI)

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

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.

Study Overview

• Status: Suspended
• Conditions: Acute Kidney Injury; Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Dapagliflozin 10mg Tab

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Cardiogenic shock /need for inotrope or mechanical pump support.
2. Acute kidney injury as defined by KDIGO criteria (<4 weeks) prior to PCI.
3. End-Stage Renal Disease prior to PCI (On renal replacement therapy).
4. Diabetes Mellitus type 1.
5. Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose >400 mg/dl).
6. ST-segment elevation Myocardial Infarction undergoing index PCI.
7. Active Genitourinary infection.
8. Diagnostic Left Heart Catheterization without PCI.
9. Patients undergoing zero contrast PCI.
10. Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
11. Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
12. Patients with Acute Heart Failure admission < 30 days prior to PCI.
13. Intercurrent illness resulting in volume depletion and hypotension (MAP<60 mmHg).
14. Patients with a kidney transplant.
15. Any contrast exposure within 14 days.
16. Patients with estimated glomerular filtration rate (eGFR) < 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
17. Patients with an active intrinsic inflammatory or autoimmune renal pathology.
18. Women of child bearing age (<50 years old).
19. Prison Inmates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin arm; Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.	Drug: Dapagliflozin 10mg Tab; One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.
No Intervention: Standard of care; Patients who received the standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Days	7 days
Incidence of genitourinary infections	Symptomatic pyuria or new vaginal infection.	7 days

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PCI; Dapagliflozin; SGLT2 inhibitor; Angiography; AKI
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: 2022-864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes