SGLT-2 Inhibitors in Prevention of Post-procedural Renal and Cardiovascular Complications aFter PCI Among Patients With Diabetes Mellitus and Coronary Artery Disease: a Prospective, Randomized, Pilot Study (SAFE-PCI) (SAFE-PCI)

September 3, 2021 updated by: Carlos Vicente Serrano Jr, University of Sao Paulo General Hospital
Patients with type 2 diabetes mellitus (DM) have higher risk of major cardiovascular events (MACE) and renal disfunction. The Sodium-glucose cotransporter-2 inhibitors (iSGLT2) reduces hyperglycemia in patients with type 2 DM and have multiple metabolic effects, lowering primary composite cardiovascular outcomes and progression to renal failure. 25% of patients with Stable Ischemic Heart Disease (SIHD) undergoing PCI are diabetics being one of the most prevalent and important risk factors for the development of contrast induced nephropathy (CIN). The occurence of CIN is associated with higher rates of death, loss of renal function, necessity of dialysis and increase of health care costs. In this pilot study we sought to evaluate if the iSGLT2 would prevent periprocedural complications - such as periprocedural CIN and MI - in type 2 DM patients undergoing PCI through the assessment of renal and myocardial biomarkers

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Prospective, unblinded, randomized (1:1), single-center pilot study of 40 patients allocated to one of the treatment arms (OMT + empaglifozin or OMT). Strategies to reduce Contrast-induced acute kidney injury will be used in both study arms
  • The study population will be composed of patients with type II diabetes mellitus and coronary artery disease (CAD) suitable for PCI of one or more coronary vessels
  • After discharge, all subjects will be clinically followed-up during hospitalization and for 30 days after PCI.
  • Unless contra-indicated, all patients will receive intravenous hydration during 12 hours pre- and 12 hours post-PCI. Saline (NaCl 0.9%) infusion is recommended at a dose of 1 ml / kg body weight per hour and reduced to 0.5 ml/kg/h for those at high risk of volume overload (e.g. reduced left ventricular function or overt heart failure). All nephrotoxic drugs will be suspended at least 24 hours before the procedure.
  • Operators will be strongly recommended to follow strict strategies to reduce the total volume of contrast for all patients
  • All percutaneous procedures will be performed using non-ionic, low-osmolar or iso-osmolar, iodine-based contrast media
  • The study groups will be compared according to the intention-to-treat principle. Categorical variables will be compared by Fisher's exact testing and continuous variables by Student's T testing. Time-dependent events will be estimated by the Kaplan-Meier method and compared by Hazards Cox modeling or log-rank test

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Type II Diabetes mellitus
  • Finding of obstructive coronary artery disease (≥50% stenosis in major epicardial vessel) and clinical indication of percutaneous coronary intervention.(PCI)
  • Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
  • Participant is willing to give written informed consent

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) < 30mL/min/1,73m2 or dialysis
  • Inability to comply with the protocol
  • Urgent need for PCI
  • Acute coronary syndrome within the previous 30 days
  • Use of iodinated contrast or other nephrotoxic agents < 7 days
  • Angina after coronary bypass surgery
  • Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
  • Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: empagliflozin + OMT
empagliflozin 25mg - Daily - at least 15 days before the PCI procedure OMT - Optimized Medical Therapy - conventional drug therapy with oral antidiabetics and/or insulin plus use of anti-platelet, anti-hypertensive and lipid-lowering agents necessary to obtain adequate values for pressure, lipid control and glycemia, in accordance with international guidelines and protocols. Strategies to reduce Contrast-induced acute kidney injury will be used in both study arms
Drug: empagliflozin 25 MG
empagliflozin 25mg - daily
No Intervention: OMT
OMT - Optimized Medical Therapy - conventional drug therapy with oral antidiabetics and/or insulin plus use of anti-platelet, anti-hypertensive and lipid-lowering agents necessary to obtain adequate values for pressure, lipid control and glycemia, in accordance with international guidelines and protocols. Strategies to reduce Contrast-induced acute kidney injury will be used in both study arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum creatinine values in pre-specified periods
Time Frame: Pre PCI
Delta and area under curve
Pre PCI
Serum creatinine values in pre-specified periods
Time Frame: Day 1
Delta and area under curve
Day 1
Serum creatinine values in pre-specified periods
Time Frame: Day 2
Delta and area under curve
Day 2
Serum creatinine values in pre-specified periods
Time Frame: Day 30
Delta and area under curve
Day 30
NGAL values in pre-specified periods
Time Frame: Pre PCI
Delta and area under curve
Pre PCI
NGAL values in pre-specified periods
Time Frame: Day 1
Delta and area under curve
Day 1
NGAL values in pre-specified periods
Time Frame: Day 2
Delta and area under curve
Day 2
NGAL values in pre-specified periods
Time Frame: Day 30
Delta and area under curve
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in serum creatinine ≥ 0.3 mg/dl or 50% from the baseline value, within 48 hours after the index procedure
Time Frame: 48 hours after PCI
CI-AKI will be defined as an increase in serum creatinine ≥ 0.3 mg/dl or 50% from the baseline value, within 48 hours after the index procedure CI-AKI will be defined as an increase in serum creatinine ≥ 0.3 mg/dl or 50% from the baseline value, within 48 hours after the index procedure
48 hours after PCI
Biomarkers elevation ≥10 upper reference limit (URL) for creatine kinase MB (CKMB) and/or ≥70 URL for troponin
Time Frame: 24 hours after PCI
Periprocedural MI will be defined as biomarkers elevation ≥10 upper reference limit (URL) for creatine kinase MB (CKMB) and/or ≥70 URL for troponin
24 hours after PCI
Occurrence of definite or probable stent thrombosis
Time Frame: Until 30 days
Stent thrombosis will be defined as the occurrence of definite or probable stent thrombosis according to the Academic Research Consortium (ARC) criteria
Until 30 days
Death From Cardiovascular Causes
Time Frame: Until 30 days
Secondary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, definite or probable stent thrombosis, stroke, bleeding (BARC 3-5) or death
Until 30 days
Myocardial Infarction
Time Frame: Until 30 days
Secondary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, definite or probable stent thrombosis, stroke, bleeding (BARC 3-5) or death
Until 30 days
Hospitalization for Unstable Angina
Time Frame: Until 30 days
Secondary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, definite or probable stent thrombosis, stroke, bleeding (BARC 3-5) or death
Until 30 days
Stroke
Time Frame: Until 30 days
Secondary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, definite or probable stent thrombosis, stroke, bleeding (BARC 3-5) or death
Until 30 days
Bleeding (BARC 3-5)
Time Frame: Until 30 days
Secondary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, definite or probable stent thrombosis, stroke, bleeding (BARC 3-5) or death
Until 30 days
Death
Time Frame: Until 30 days
Secondary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, definite or probable stent thrombosis, stroke, bleeding (BARC 3-5) or death
Until 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Mateus P Feitosa, MD, Instituto do Coracao - HCFMUSP
  • Study Director: Carlos V Serrano, MD, Instituto do Coracao - HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFE-PCI

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on empagliflozin 25 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe