Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02634203
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2015-12-08
Brief Title:
Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACE
Brief Summary:
Chronic thromboembolic pulmonary hypertension CTEPH is a severe form of pulmonary hypertension characterized by obstruction of the pulmonary vasculature by residual organized thrombi leading to increased pulmonary vascular resistance PVR progressive pulmonary hypertension and right failure
In patients deemed operable pulmonary endarterectomy PEA is the gold standard treatment and is the only potentially curative treatment However some patients are ineligible for surgery owing to occlusion of distal vessels The best treatment option for these non-operable CTEPH patients is not yet established
In patients deemed operable pulmonary endarterectomy PEA is the gold standard treatment and is the only potentially curative treatment However some patients are ineligible for surgery owing to occlusion of distal vessels The best treatment option for these non-operable CTEPH patients is not yet established
Detailed Description:
Currently riociguat is the only drug approved in Europe and US for the treatment of non-operable CTEPH However medical therapy with riociguat does not address obstructive lesions In this sense another treatment option balloon pulmonary angioplasty BPA began recently to gain widespread interest after development in several centers This procedure uses the standard balloon angioplasty technique to dilate selected pulmonary arteries The main aim is to reopen vessels occluded by webs and bands Several teams mainly from Japan have reported their experiences with BPA for the treatment of non-operable CTEPH and demonstrated impressive decrease in pulmonary vascular resistance and improvement in functional status and exercise capacity with an acceptable procedure-related risk Although BPA has never been prospectively evaluated most of the leading CTEPH centers worldwide have currently added BPA to their therapeutic options However no randomized controlled trial comparing safety and efficacy of medical therapy with riociguat versus pulmonary balloon angioplasty has been performed so far Therefore the respective places of medical treatment and of BPA in the management of inoperable patients with CTEPH need to be further evaluated
An ancillary study will evaluate the efficacy and safety of employment of two sequentially used treatments at 12 months The studied population is that of the study RACE The patient follow-up period will be extended by 6 months its duration of participation will be in total of 13 months The exams will be the same as those of the V3 of the RACE study
An ancillary study will evaluate the efficacy and safety of employment of two sequentially used treatments at 12 months The studied population is that of the study RACE The patient follow-up period will be extended by 6 months its duration of participation will be in total of 13 months The exams will be the same as those of the V3 of the RACE study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-A00973-46 | OTHER | IDRCB | None |