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

A

Albert Einstein Healthcare Network

Status and phase

Suspended
Phase 4

Conditions

Percutaneous Coronary Intervention
Acute Kidney Injury

Treatments

Drug: Dapagliflozin 10mg Tab

Study type

Interventional

Funder types

Other

Identifiers

NCT05435235
2022-864

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Patients with estimated glomerular filtration rate (eGFR) < 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
  • Patients with an active intrinsic inflammatory or autoimmune renal pathology.
  • Women of child bearing age (<50 years old).
  • Prison Inmates

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

250 participants in 2 patient groups

Dapagliflozin arm
Experimental group
Description:
Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.
Treatment:
Drug: Dapagliflozin 10mg Tab
Standard of care
No Intervention group
Description:
Patients who received the standard of care.

Trial contacts and locations

1

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Central trial contact

Francisco A Aguilar, MD; Gregg S Pressman, MD

Data sourced from clinicaltrials.gov

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