NCT05225077

Brief Summary

This study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in CKD patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of CIN.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

January 25, 2022

Last Update Submit

January 25, 2022

Conditions

Renal Insufficiency, ChronicCardiac CatheterizationPercutaneous Coronary Intervention

Keywords

Sodium-Glucose Transporter 2 InhibitorsDapaglifozinChronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of contrast induced nephropathy

    Serum creatinine (Scr) elevation of \>25% or \>0.5 mg/dl (44 μmol/l) from baseline within 48 hours

    48 hours

Study Arms (2)

Dapagliflozin 10mg group

ACTIVE COMPARATOR

Dapagliflozin 10 mg once a day for 1 month after the procedure.

Drug: Dapagliflozin 10 MG [Farxiga]

Non-intervention group

NO INTERVENTION

No intervention.

Interventions

Dapagliflozin 10 MG [Farxiga]DRUG

Dapagliflozin 10 mg once a day for 1 month after CAG or PCI.

Dapagliflozin 10mg group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18 years
  • Written informed consent
  • Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 \[CKD stage G1-G3\]
  • Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients

You may not qualify if:

  • Active malignancy
  • Class I or equivalent indication for treatment with a SGLT2 inhibitor
  • Pregnancy or willing of pregnancy during the follow up period
  • Active urogenital infection
  • Diabetes mellitus type 1
  • History of diabetic ketoacidosis
  • Cardiogenic shock
  • eGFR \< 29 ml/min/1.73m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong A University Hospital

Busan, 602-715, South Korea

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

February 4, 2022

Record last verified: 2022-01

Locations

KR(1)