Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)

Summary

This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.

Timeline

Start

2018-08-17

Primary completion

2020-05-05

Completion

2020-05-05

Outcome

Outcome not reported

Stopped (Enrollment): “The study was stopped due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic, both of which made study completion within a reasonable timeframe appear unlikely.”

Drugs

Indications