A randomized, double-blind, placebo-controlled, multi-center, phase 2 clinical study in patients with NSTEMI undergoing urgent coronary angiography. Approximately 220 patients with CKD and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI).
Approximately 220 patients with chronic kidney disease (CKD) and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI) will be screened for the study. Only patients with acute NSTEMI presumed to be a spontaneous myocardial infarction, related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection (i.e. type 1) are eligible. Written informed consent will be obtained before urgent coronary angiography. Patients with NSTEMI will typically undergo coronary angiography within 72 hours after admission and/or diagnosis of NSTEMI. It is estimated that 70% of these patients will have PCI. Randomization will continue until the 160th patient has had a PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
29
Conestat alfa will be dosed by body weight at 50 U/kg (maximum 4200 U) or 100 U/kg (maximum 8400 U). Placebo will consist of normal saline (NaCl 0.9%). The interventions will be given to the patients by IV-line.
University Hospital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
University Hospital Geneva
Geneva, Switzerland
Fondazione Istituto Cardiocentro Ticino
Lugano, Switzerland
Urinary NGAL
Evaluation of the peak change of urinary NGAL, an established biomarker of AKI, within 24 hours after PCI
Time frame: 24 hours after PCI
Urinary NGAL
The peak change of urinary NGAL within 24 hours after angiography for the total group including PCI and non-PCI patients
Time frame: within 24 hours after angiography
Serum creatinine
The incidence of acute kidney injury (AKI) as defined by a serum creatinine change of ≥26.5 µmol/L or a serum creatinine change of ≥1.5 times baseline within 72 hours after angiography.
Time frame: within 72 hours after angiography
Serum cystatin C
The incidence of a serum cystatin C change of ≥10% 24 hours after angiography.
Time frame: 24 hours after angiography
Troponin T
The change of troponin T within 72 hours (area under the curve, AUC0-72) after angiography
Time frame: within 72 hours after angiography
Troponin T
The peak change of troponin
Time frame: measured once at 72 hours after angiography
Creatine kinase
The peak change of creatine kinase
Time frame: measured once at 72 hours after angiography
N-terminal pro-brain natriuretic peptide
N-terminal pro-brain natriuretic peptide (NT-proBNP) measured once at 72 hours after angiography
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at 72 hours after angiography