Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3609
Source ID: NCT05037695
Associated Drug: Empagliflozin 25 Mg
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)
Acronym: SAFE-PCI
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Coronary Artery Disease|Acute Kidney Injury
Interventions: DRUG: empagliflozin 25 MG
Outcome Measures: Primary: Serum creatinine values in pre-specified periods, Delta and area under curve, Pre PCI|Serum creatinine values in pre-specified periods, Delta and area under curve, Day 1|Serum creatinine values in pre-specified periods, Delta and area under curve, Day 2|Serum creatinine values in pre-specified periods, Delta and area under curve, Day 30|NGAL values in pre-specified periods, Delta and area under curve, Pre PCI|NGAL values in pre-specified periods, Delta and area under curve, Day 1|NGAL values in pre-specified periods, Delta and area under curve, Day 2|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|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|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|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|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|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|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|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|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
Sponsor/Collaborators: Sponsor: University of Sao Paulo General Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-07-21
Completion Date: 2022-12
Results First Posted:
Last Update Posted: 2021-09-08
Locations: Instituto do Coracao - HCFMUSP, Sao Paulo, 05403000, Brazil
URL: https://clinicaltrials.gov/show/NCT05037695