Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation: a Multi-center, Randomized, Double-blind, Placebo-controlled Investigational Study (PAIR-TAVI).
Who is this study for? Patients with Acute Ischemic Stroke, Renal Injury
What treatments are being studied? Conestat Alfa (Ruconest®)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS) compared to placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Informed consent as documented by signature
• Severe AS and scheduled for transfemoral TAVI
Locations
Other Locations
Switzerland
University Hospital Basel, Division of Internal Medicine
RECRUITING
Basel
Stadtspital Triemli Zürich, Division of Cardiology
RECRUITING
Zurich
Contact Information
Primary
Michael Osthoff, Prof. Dr. med.
michael.osthoff@usb.ch
+41 61 328 54 20
Backup
Stephan Moser, Dr. med.
stephan.moser@usb.ch
+41 61 265 25 25
Time Frame
Start Date: 2022-03-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 250
Treatments
Active_comparator: Conestat alfa (Ruconest®) intervention group
The intervention group will receive conestat alfa (Ruconest®) as a 10-minute slow intravenous injection (up to 56 ml) once during the TAVI procedure followed by a second administration (up to 28 ml) again three hours later. The first administration will include a dosage of 100 U/kg (maximum 8400 U) conestat alfa. The dosing of the second administration will be 50 U/kg (maximum 4200 U).
Placebo_comparator: saline injection placebo group
Subjects randomized into the placebo group will receive an intravenous normal saline injection with corresponding volume over 10 minutes during the TAVI procedure and three hours later after the first administration.
Authors
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland
Collaborators: Pharming Technologies B.V., Swiss National Science Foundation