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

Acute Kidney Injury Clinical Trial

— DAPA-PCI-AKI  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05435235
• Other study ID #: 2022-864
• Status: Suspended
• Phase: Phase 4
• Start date: March 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 250
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Percutaneous Coronary Intervention
• Wounds and Injuries

Intervention

Drug:
• Dapagliflozin 10mg Tab
One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.

Locations

Country	Name	City	State
United States	Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospital stay	Days	7 days
Secondary	Incidence of genitourinary infections	Symptomatic pyuria or new vaginal infection.	7 days