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Diabetes Mellitus, Type 2Phase 4SAFE-PCINCT05037695

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)

A Phase 4 study testing empagliflozin 25 MG in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
empagliflozin 25 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
21 Jul 2021to Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mateus P Feitosa, MD contact

55-85-997734072

mateusfeitosa@hotmail.com

Carlos V Serrano, MD contact

55-11-26615352

carlos.serrano@incor.usp.br

Brazil1 site, 1 recruiting

  • Instituto do Coracao - HCFMUSP

    São Paulo, 05403000

    Mateus P Feitosa, MD, 55-85-997734072, mateus.feitosa@incor.usp.br

    Carlos V Serrano, MD, 55-11-26615352, carlos.serrano@incor.usp.br

    Recruiting

Other trials in Brazil

About this study

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

Read the 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
Being tested
empagliflozin 25 MG
Keywords
PCI
Medical subject headings
Diabetes Mellitus, Type 2, Coronary Artery Disease, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • empagliflozin 25 MGDrug

    empagliflozin 25mg - daily

Study groups in NCT05037695
Study groupRoleWhat they receive
empagliflozin + OMTExperimentalempagliflozin 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
Receives: Drug: empagliflozin 25 MG
OMTNo interventionOMT - 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum creatinine values in pre-specified periods

    Delta and area under curve

    Measured: Pre PCI

  2. Serum creatinine values in pre-specified periods

    Delta and area under curve

    Measured: Day 1

  3. Serum creatinine values in pre-specified periods

    Delta and area under curve

    Measured: Day 2

  4. Serum creatinine values in pre-specified periods

    Delta and area under curve

    Measured: Day 30

  5. NGAL values in pre-specified periods

    Delta and area under curve

    Measured: Pre PCI

  6. NGAL values in pre-specified periods

    Delta and area under curve

    Measured: Day 1

  7. NGAL values in pre-specified periods

    Delta and area under curve

    Measured: Day 2

  8. NGAL values in pre-specified periods

    Delta and area under curve

    Measured: Day 30

Secondary outcomes (9)

  1. 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 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

    Measured: 48 hours after PCI

  2. Biomarkers elevation ≥10 upper reference limit (URL) for creatine kinase MB (CKMB) and/or ≥70 URL for troponin

    Periprocedural MI will be defined as biomarkers elevation ≥10 upper reference limit (URL) for creatine kinase MB (CKMB) and/or ≥70 URL for troponin

    Measured: 24 hours after PCI

  3. Occurrence of definite or probable stent thrombosis

    Stent thrombosis will be defined as the occurrence of definite or probable stent thrombosis according to the Academic Research Consortium (ARC) criteria

    Measured: Until 30 days

  4. Death From Cardiovascular Causes

    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

    Measured: Until 30 days

  5. Myocardial Infarction

    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

    Measured: Until 30 days

  6. Hospitalization for Unstable Angina

    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

    Measured: Until 30 days

  7. Stroke

    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

    Measured: Until 30 days

  8. Bleeding (BARC 3-5)

    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

    Measured: Until 30 days

  9. Death

    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

    Measured: Until 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2021
  2. Study start21 Jul 2021
  3. Primary completionJul 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, unblinded, randomized (1:1), single-center pilot study of 40 patients allocated to one of the treatment arms (OMT + empagliflozin or OMT).
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037695
Sponsor's protocol ID
SAFE-PCI
Acronym
SAFE-PCI
Status last verified
Sep 2021
First submitted
21 Jun 2021
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mehran R, Nikolsky E. Contrast-induced nephropathy: definition, epidemiology, and patients at risk. Kidney Int Suppl. 2006 Apr;(100):S11-5. doi: 10.1038/sj.ki.5000368.

    PubMed 16612394

  • Almendarez M, Gurm HS, Mariani J Jr, Montorfano M, Brilakis ES, Mehran R, Azzalini L. Procedural Strategies to Reduce the Incidence of Contrast-Induced Acute Kidney Injury During Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2019 Oct 14;12(19):1877-1888. doi: 10.1016/j.jcin.2019.04.055. Epub 2019 Sep 11.

    PubMed 31521648

  • Bahrainwala JZ, Leonberg-Yoo AK, Rudnick MR. Use of Radiocontrast Agents in CKD and ESRD. Semin Dial. 2017 Jul;30(4):290-304. doi: 10.1111/sdi.12593. Epub 2017 Apr 5.

    PubMed 28382626

  • Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn SM, Zhang Z, Shahinfar S; RENAAL Study Investigators. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001 Sep 20;345(12):861-9. doi: 10.1056/NEJMoa011161.

    PubMed 11565518

  • Chang YK, Choi H, Jeong JY, Na KR, Lee KW, Lim BJ, Choi DE. Dapagliflozin, SGLT2 Inhibitor, Attenuates Renal Ischemia-Reperfusion Injury. PLoS One. 2016 Jul 8;11(7):e0158810. doi: 10.1371/journal.pone.0158810. eCollection 2016.

    PubMed 27391020

  • Das SR, Everett BM, Birtcher KK, Brown JM, Cefalu WT, Januzzi JL Jr, Kalyani RR, Kosiborod M, Magwire ML, Morris PB, Sperling LS. 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2018 Dec 18;72(24):3200-3223. doi: 10.1016/j.jacc.2018.09.020. Epub 2018 Nov 26. No abstract available.

    PubMed 30497881

  • Donahoe SM, Stewart GC, McCabe CH, Mohanavelu S, Murphy SA, Cannon CP, Antman EM. Diabetes and mortality following acute coronary syndromes. JAMA. 2007 Aug 15;298(7):765-75. doi: 10.1001/jama.298.7.765.

    PubMed 17699010

  • Feres F, Costa RA, Siqueira D, Costa JR Jr, Chamie D, Staico R, Chaves AJ, Abizaid A, Marin-Neto JA, Rassi A Jr, Botelho R, Alves CMR, Saad JA, Mangione JA, Lemos PA, Quadros AS, Queiroga MAC, Cantarelli MJC, Figueira HR. DIRETRIZ DA SOCIEDADE BRASILEIRA DE CARDIOLOGIA E DA SOCIEDADE BRASILEIRA DE HEMODINAMICA E CARDIOLOGIA INTERVENCIONISTA SOBRE INTERVENCAO CORONARIA PERCUTANEA. Arq Bras Cardiol. 2017 Jun;109(1 Suppl 1):1-81. doi: 10.5935/abc.20170111. No abstract available. Portuguese.

    PubMed 28792984

  • Gilbert RE, Thorpe KE. Acute kidney injury with sodium-glucose co-transporter-2 inhibitors: A meta-analysis of cardiovascular outcome trials. Diabetes Obes Metab. 2019 Aug;21(8):1996-2000. doi: 10.1111/dom.13754. Epub 2019 May 24.

    PubMed 31050116

  • Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21.

    PubMed 19850388

  • Hueb W, Gersh BJ, Costa F, Lopes N, Soares PR, Dutra P, Jatene F, Pereira AC, Gois AF, Oliveira SA, Ramires JA. Impact of diabetes on five-year outcomes of patients with multivessel coronary artery disease. Ann Thorac Surg. 2007 Jan;83(1):93-9. doi: 10.1016/j.athoracsur.2006.08.050.

    PubMed 17184637

  • James MT, Ghali WA, Tonelli M, Faris P, Knudtson ML, Pannu N, Klarenbach SW, Manns BJ, Hemmelgarn BR. Acute kidney injury following coronary angiography is associated with a long-term decline in kidney function. Kidney Int. 2010 Oct;78(8):803-9. doi: 10.1038/ki.2010.258. Epub 2010 Aug 4.

    PubMed 20686453

  • Kidokoro K, Cherney DZI, Bozovic A, Nagasu H, Satoh M, Kanda E, Sasaki T, Kashihara N. Evaluation of Glomerular Hemodynamic Function by Empagliflozin in Diabetic Mice Using In Vivo Imaging. Circulation. 2019 Jul 23;140(4):303-315. doi: 10.1161/CIRCULATIONAHA.118.037418. Epub 2019 Feb 18.

    PubMed 30773020

  • Korner A, Eklof AC, Celsi G, Aperia A. Increased renal metabolism in diabetes. Mechanism and functional implications. Diabetes. 1994 May;43(5):629-33. doi: 10.2337/diab.43.5.629.

    PubMed 8168637

  • Lima EG, Hueb W, Garcia RM, Pereira AC, Soares PR, Favarato D, Garzillo CL, D'Oliveira Vieira R, Rezende PC, Takiuti M, Girardi P, Hueb AC, Ramires JA, Kalil Filho R. Impact of diabetes on 10-year outcomes of patients with multivessel coronary artery disease in the Medicine, Angioplasty, or Surgery Study II (MASS II) trial. Am Heart J. 2013 Aug;166(2):250-7. doi: 10.1016/j.ahj.2013.04.017. Epub 2013 Jun 15.

    PubMed 23895807

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing empagliflozin 25 MG in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mateus P Feitosa, MD (55-85-997734072, mateusfeitosa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum creatinine values in pre-specified periods (time frame: Pre PCI). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037695, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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