PEA Bridging Study
In June 2018, the ICA initiated a randomised placebo-controlled, double-blind clinical trial to determine the efficacy of riociguat on pre- and post-operative pulmonary haemodynamic parameters in patients with severe operable CTEPH:
A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance (PEA bridging study).
The study aimed to enrol 88 patients over the course of 2 years. Due to slow enrolment and the additional limitations on clinical research imposed by the COVID-19 pandemic in spring 2020, the study was terminated early in April 2020. At this time, 11 patients had completed a 3-month course of blinded trial medication and undergone surgery.
The key objectives for this study were to:
- Assess the efficacy of riociguat on preoperative PVR in patients with operable CTEPH
- Assess the efficacy of riociguat on pre- and post-operative pulmonary haemodynamic parameters in patients with operable CTEPH
Four expert sites from the UK, France, Germany and the United States participated in this study.
The PEA bridging study was funded by Bayer AG.
The study is registered on clinicaltrials.gov under NCT03273257 and on EudraCT under the trial number 2017-001121-40. Analysis of the collected data is ongoing and results will be posted on these sites once available.