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STOP-RIO: A randomized controlled non-inferiority trial to test the safety of discontinuation of riociguat after balloon pulmonary angioplasty in Chronic Thrombo-embolic Pulmonary Hypertension
EU CTIS ID: 2024-519225-38-00
What this study is testing
To assess the safety and feasibility of stopping riociguat in CTEPH patients who reach an mPAP < 30 mmHg at least 6 months after the last BPA.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- CTEPH diagnosis in accordance with European guidelines applicable at the time of diagnosis
- The availability of a documented post-BPA follow-up RHC performed within the last 3 months OR an anticipated post-BPA follow-up RHC with an mPAP <30 mmHg as determined by the treating physician's judgement
- Riociguat monotherapy initiated prior to or within 2 weeks after the first BPA treatment
- The capacity to adhere to the study visit schedule and to comprehend and comply with all protocol requirements
- Ability to understand and provide written informed consent in the Dutch language
You likely can't join if
- WHO functional class IV
- Cardiac index <2.2l/min/m2
- A post-BPA follow-up RHC within 3 months indicating an mPAP ≥ 30 mmHg
- Patients who received any investigational medication within 1 month prior to the start of this study or who are scheduled to receive another investigational drug during the course of this study
- A history of PEA prior to BPA
- Presence of any other disease with a life expectancy of <1 year in the investigator’s opinion
See the full eligibility criteria
- Age ≥18 years
- CTEPH diagnosis in accordance with European guidelines applicable at the time of diagnosis
- The availability of a documented post-BPA follow-up RHC performed within the last 3 months OR an anticipated post-BPA follow-up RHC with an mPAP <30 mmHg as determined by the treating physician's judgement
- Riociguat monotherapy initiated prior to or within 2 weeks after the first BPA treatment
- The capacity to adhere to the study visit schedule and to comprehend and comply with all protocol requirements
- Ability to understand and provide written informed consent in the Dutch language
- WHO functional class IV
- Cardiac index <2.2l/min/m2
- A post-BPA follow-up RHC within 3 months indicating an mPAP ≥ 30 mmHg
- Patients who received any investigational medication within 1 month prior to the start of this study or who are scheduled to receive another investigational drug during the course of this study
- A history of PEA prior to BPA
- Presence of any other disease with a life expectancy of <1 year in the investigator’s opinion
- History or suspicion of inability to cooperate adequately
- Any condition that makes participation in this study inappropriate or unlikely to complete the trial period in the investigators opinion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.