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NCT03273257 · ClinicalTrials.gov registry record · Phase 2
Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)
A Phase 2 study, sponsored by International CTEPH Association.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03273257: Clinical Trial Phase 2 study, sponsored by International CTEPH Association.
NCT03273257 is a Phase 2 study that was terminated before completion, run by International CTEPH Association. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03273257, a Phase 2 study, was terminated before completion, sponsored by International CTEPH Association.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
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.
Primary Outcome
Pulmonary vascular resistance (PVR) will be assessed at baseline and immediately before pulmonary endarterectomy. The change in PVR will be assessed as percentage.
Interventions
- DRUG Placebo
- DRUG Riociguat
- PROCEDURE Pulmonary endarterectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-08-17 |
| Est. Completion | 2020-05-05 |
| Phase | Phase 2 |
Why NCT03273257 stopped before completion
NCT03273257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03273257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03273257 about?
NCT03273257 is a clinical study titled "Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)". 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 r...
What is the current status of trial NCT03273257?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-08-17. Estimated completion is 2020-05-05.
What interventions are being tested in trial NCT03273257?
The interventions under investigation include: Placebo (DRUG), Riociguat (DRUG), Pulmonary endarterectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03273257?
This trial is sponsored by International CTEPH Association, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03273257's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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