Prevention of Acute Kidney Injury in Patients With NSTEMI — AKI  

Non-ST Elevation Myocardial Infarction (NSTEMI) Clinical Trial

Official title: Conestat Alfa (a Recombinant Human C1 Esterase Inhibitor) for the Prevention of Acute Kidney Injury After Non-ST Elevation Myocardial Infarction: a Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2, Dose-finding Study

Status Terminated

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acute Kidney Injury
• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction (NSTEMI)

• NCT number: NCT04912141
• Study type: Interventional
• Source: Pharming Technologies B.V.
• Status: Terminated
• Phase: Phase 2
• Start date: April 21, 2021
• Completion date: April 28, 2023