Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain Caused by Bleeding Onto the Surface of the Brain
BAZ Megyei K rh z s Egyetemi Oktat K rh z Neuroradiol giai s angiogr phi s oszt ly(1.4 mi away)Contact
+228 other location
This study will evaluate if clazosentan (on top of normal routine medical care) can reduce
the risk of developing complications related to cerebral vasospasm and permanent brain damage
as compared to normal routine medical care alone.
When a blood vessel just outside the brain bursts and causes bleeding onto its surface, the
space surrounding the brain (the subarachnoid space) fills with blood. This condition is
called subarachnoid hemorrhage. The bleeding due to the rupture of a pouch-like structure or
a bulge (called an aneurysm) that formed on one of the blood vessels is condition called
aneurysmal subarachnoid hemorrhage (aSAH).
In this study, clazosentan is being tested against normal routine medical care to determine
if clazosentan can reduce the risk of developing complications related to vasospasm and
permanent brain damage.
Participation will last for approximately 6 months from the episode of bleeding. For subjects
randomized in the high-risk prevention group, treatment will start within 96 hours following
the time of the aneurysm rupture, and be administered where possible, for 14 days. For
subjects randomized in the early treatment group, treatment must begin within 24 hours of the
time of the angiogram documenting the cerebral vasospasm necessary for entry into the study.
Treatment will be administered for a minimum of 6 days and a maximum of 14 days. Recruitment
in the early treatment group has been discontinued.
The end-of-study will be conducted as a telephone interview 6 months after the episode of
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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