The ICA has 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 key objectives for this study are 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
Funding of the PEA bridging study has been secured by the financial support of Bayer AG.
The study is registered on clinicaltrials.gov under NCT03273257. The EudraCT number is 2017-001121-40.
Four expert sites from the UK, France, Germany and the United States will participate in this study.