NCT03273257

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: International CTEPH Association · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Thromboembolic Pulmonary Hypertension
• CTEPH

Interventions

Type	Name	Description
DRUG	Riociguat	Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid. Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability.
DRUG	Placebo	Placebo will be given analogue to riociguat with matching tablets.
PROCEDURE	Pulmonary endarterectomy	PEA will be performed at the end of medical treatment (Day 90)

Timeline

• Start date: 2018-08-17
• Primary completion: 2020-05-05
• Completion: 2020-05-05
• First posted: 2017-09-06
• Last updated: 2021-06-22
• Results posted: 2021-06-22

Locations

4 sites across 4 countries: United States, France, Germany, United Kingdom

Regulatory

• FDA-regulated drug study