On October 21st, 2009, the Los Angeles Brain and Spine Institute enrolled the first two patients on the west coast into a trial designed to prevent stroke after rupture of a brain aneurysm. The patients had their aneurysms treated with a minimally invasive coiling procedure, then were randomized into the Conscious 3 trial. This trial studies the effectiveness of Clozosentan in preventing poor outcomes due to vasospasm after aneurysm rupture.
(PRWEB) November 23, 2009 -- On October 21st, 2009, the Los Angeles Brain and Spine Institute enrolled the first two patients on the west coast into the Conscious-3 ( C3) trial, studying the effects of the drug Clozosentan in the prevention of stroke after rupture of a brain aneurysm. The C3 trial is an international phase 3 trial investigating the study drug in preventing stroke due to vasospasm after subarachnoid hemorrhage. Subarachnoid hemorrhage occurs with bleeding in the brain, due to rupture of a brain aneurysm. A brain aneurysm is a bubble that forms on a brain artery, which can be prone to bleeding. While technological advances have occurred in the treatment of brain aneurysms many patients still succumb from the effects of the actual brain hemorrhage. Surgery to fix the aneurysm can prevent further bleeding; however it cannot reverse the effects of bleeding in the brain.
One of the most severe obstacles affecting survivors of brain aneurysm rupture is cerebral vasospasm. This occurs 4 to 10 days after a brain aneurysm ruptures and results in a clamping down, or spasm of the brain arteries. This deprives the brain of blood and oxygen and can result in stroke. 40% of people who survive a ruptured brain aneurysm become disabled or die from vasospasm. A ruptured brain aneurysm itself is very deadly, resulting in death in about half of all cases. To date there has been no effective way to prevent vasospasm.
Clazosentan is being developed by Actelion as an intravenous infusion to treat patients with aneurysm related subarachnoid hemorrhage to prevent cerebral vasospasm and subsequent stroke. Clazosentan shows high specificity for a protein, an endothelin receptor, found in arteries of the brain. In a phase 2 study high dosages of clozosentan were associated with a 65% relative risk reduction in the development of vasospasm.
Patients enrolled in C3 have to have their aneurysm coiled, not clipped. Coiling is a minimally invasive procedure, done by threading a small catheter from the groin to the brain. Once in the aneurysm tiny coils are placed, blocking it from the circulatory system. Clipping is a traditional method of aneurysm surgery, requiring bone to be removed from the skull and the direct application of a clip on the aneurysm. Only specialized centers perform coiling. Dr. George Rappard, medical director of the Los Angeles Brain and Spine Institute, is a Neurointerventional Surgeon specializing in the coiling procedure and the care of critical subarachnoid hemorrhage patients. Dr. Rappard is the primary investigator for the C3 trial in the Los Angeles area.
On the west coast, the C3 trial is also being conducted at Oregon Health Sciences University and Stanford University.
For more information visit www.LABrainandSpine.com or call 1-818-949-4900. Additional information on the Conscious-3 trial can be found at www.strokecenter.info/trials .
You can follow the Los Angeles Brain and Spine Institute on twitter: www.Twitter.com/LABrainandSpine
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