Back to resultsDapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury (DAPA-PCI-AKI)
Primary Purpose
Acute Kidney Injury, Percutaneous Coronary Intervention
Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin 10mg Tab
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring SGLT2 inhibitor, Dapagliflozin, AKI, PCI, Angiography
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or more.
- Scheduled/non-emergent Percutaneous coronary intervention (PCI).
- Post-index procedure Staged PCI with at least 30 days from contrast exposure.
- Patient is able to fully understand 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 >300 mg/dl).
- ST-segment elevation Myocardial Infarction undergoing index PCI.
- Active Genitourinary infection.
- Diagnostic Left Heart Catheterization without PCI.
- Patient's 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 hemodynamical 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<65 mmHg).
- Patients with a kidney transplant.
- Any contrast exposure within 30 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 renal pathology.
- Pregnancy.
- Prison Inmates
Sites / Locations
- Einstein Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dapagliflozin arm
Standard of care
Arm Description
Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.
Patients who received the standard of care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Length of hospital stay
Days
Incidence of genitourinary infections
Symptomatic pyuria or new vaginal infection.
Full Information
NCT ID
NCT05435235
First Posted
June 23, 2022
Last Updated
June 29, 2023
Sponsor
Albert Einstein Healthcare Network
1. Study Identification
Unique Protocol Identification Number
NCT05435235
Brief Title
Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury
Acronym
DAPA-PCI-AKI
Official Title
Dapagliflozin in the Prevention of Post-Coronary Intervention Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Laboratory UNGAL
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Percutaneous Coronary Intervention
Keywords
SGLT2 inhibitor, Dapagliflozin, AKI, PCI, Angiography
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin arm
Arm Type
Experimental
Arm Description
Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Patients who received the standard of care.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10mg Tab
Intervention Description
One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.
Primary Outcome Measure Information:
Title
Acute Kidney Injury
Description
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.
Time Frame
Within 7 days.
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Days
Time Frame
7 days
Title
Incidence of genitourinary infections
Description
Symptomatic pyuria or new vaginal infection.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury
We'll reach out to this number within 24 hrs