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

NCT03273257 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-06-22

Study results available
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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

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)

Sponsors & Collaborators

  • International CTEPH Association

    lead OTHER

Principal Investigators

  • David Jenkins, MD · Papworth Hospital NHS Foundation Trust, Cambridge, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2020-05-05
Completion
2020-05-05
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03273257 on ClinicalTrials.gov