E-Selectin Nasal Spray to Prevent Stroke Recurrence
|ClinicalTrials.gov Identifier: NCT00012454|
Recruitment Status : Terminated
First Posted : March 17, 2003
Last Update Posted : May 4, 2010
This study will test the safety and effectiveness of a protein called E-selectin, given as a nasal spray, in preventing the formation of blood clots that can cause stroke. In animal studies, animals that received E-selectin in the nose on a regular schedule had almost no strokes compared with those that did not receive it.
Patients over age 45 who have had a stroke or transient ischemic attack (TIA) within 1 to 4 months of this study may be eligible to participate. Candidates will be screened with a review of their past medical records and neurologic and medical evaluations that may include magnetic resonance imaging (MRI) of the brain, ultrasound or magnetic resonance angiography (a type of MRI) of the carotid arteries (arteries in the neck that supply blood to the brain), echocardiography (ultrasound test of the heart), electrocardiography (EKG) and blood tests.
Participants will have a blood and urine test and will be assigned to one of four treatment groups. Patients in each group will spray a small amount of fluid into their nose according to the following schedule: 5 doses once every other day for 10-days, followed in 3 weeks by another 5 doses every other day for 10-days, followed in 3 weeks by a final series of 5 doses every other day for 10 days. The spray for patients in each group contains the following:
- Group 1 - fluid with low dose of E-selectin
- Group 2 - fluid with medium dose of E-selectin
- Group 3 - fluid with high dose of E-selectin
- Group 4 - fluid with no E-selectin
Patients will be seen for follow-up visits at 1 month and 3 months after starting E-selectin therapy. The visits will include a neurologic examination and blood and urine tests. Patients will be contacted by phone, fax or e-mail in between the 1- and 3-month visits.
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident Transient Ischemic Attack||Drug: E-Selectin nasal spray||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Official Title:||Induction of Mucosal Tolerance to E-Selectin for the Secondary Prevention of Stroke|
|Study Start Date :||March 2001|
|Study Completion Date :||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012454
|United States, Maryland|
|National Institute of Neurological Disorders and Stroke (NINDS)|
|Bethesda, Maryland, United States, 20892|