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)

Coronary Artery Disease Clinical Trial

— SAFE-PCI  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05037695
• Other study ID #: SAFE-PCI
• Status: Recruiting
• Phase: Phase 4
• Start date: July 21, 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: University of Sao Paulo General Hospital
• Contact: Mateus P Feitosa, MD
• Phone: 55-85-997734072
• Email: mateusfeitosa[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia

Intervention

Drug:
• empagliflozin 25 MG
empagliflozin 25mg - daily

Locations

Country	Name	City	State
Brazil	Instituto do Coracao - HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine values in pre-specified periods	Delta and area under curve	Pre PCI
Primary	Serum creatinine values in pre-specified periods	Delta and area under curve	Day 1
Primary	Serum creatinine values in pre-specified periods	Delta and area under curve	Day 2
Primary	Serum creatinine values in pre-specified periods	Delta and area under curve	Day 30
Primary	NGAL values in pre-specified periods	Delta and area under curve	Pre PCI
Primary	NGAL values in pre-specified periods	Delta and area under curve	Day 1
Primary	NGAL values in pre-specified periods	Delta and area under curve	Day 2
Primary	NGAL values in pre-specified periods	Delta and area under curve	Day 30
Secondary	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	48 hours after PCI
Secondary	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	24 hours after PCI
Secondary	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	Until 30 days
Secondary	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	Until 30 days
Secondary	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	Until 30 days
Secondary	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	Until 30 days
Secondary	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	Until 30 days
Secondary	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	Until 30 days
Secondary	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	Until 30 days