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The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desmoteplase, low dose | Experimental | Desmoteplase 90 mcg/kg, intravenous administration. |
|
| Desmoteplase, high dose | Experimental | Desmoteplase 125 mcg/kg, intravenous administration. |
|
| Placebo | Placebo Comparator | Dose-Match Placebo, intravenous administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmoteplase | Drug | Desmoteplase 90 mcg/kg, intravenous administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | Improvement of greater than or equal to 8 points from baseline, or NIHSS score less than or equal to 1. The NIHSS score ranges from 0 (least severe) to 42 (more severe). | Change from Baseline to day 90 |
| Modified Rankin Scale (MRS) | Improvement on the Modified Rankin Scale, defined as a score of 0-2. The MRS ranges in severity from 0 (no symptoms) to 6 (Dead). | Day 90 |
| Barthel Index (BI) score of 75-100. | The Barthel Index (BI) is a scale used to measure performance in basic Activities of Daily Livingranges from 0 (most disablility) to 100 (no disability) | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with improvement in NIHSS score | Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1. | From Baseline to Day 90 |
| Percentage of patients with MRS score of 0-2 |
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Inclusion Criteria:
Inclusion Criteria from diagnostic imaging screening:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Lipka, MD | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Neurological Institute, Dept. of Neurology | Birmingham | Alabama | 35209 | United States | ||
| University of California Los Angeles Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22738918 | Derived | Warach S, Al-Rawi Y, Furlan AJ, Fiebach JB, Wintermark M, Lindsten A, Smyej J, Bharucha DB, Pedraza S, Rowley HA. Refinement of the magnetic resonance diffusion-perfusion mismatch concept for thrombolytic patient selection: insights from the desmoteplase in acute stroke trials. Stroke. 2012 Sep;43(9):2313-8. doi: 10.1161/STROKEAHA.111.642348. Epub 2012 Jun 26. | |
| 22474060 |
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| Desmoteplase |
| Drug |
Desmoteplase 125 mcg/kg, intravenous administration. |
|
| Placebo | Drug | Dose-Match Placebo, intravenous administration. |
|
| Day 90 |
| Percentage of patients with BI score of 75-100 | Day 90 |
| Infarct Volume | Change from baseline to Day 30 |
| Los Angeles |
| California |
| 90024-1777 |
| United States |
| Brain Matters, Inc. | Delray Beach | Florida | 33445 | United States |
| Melbourne Internal Medicine Associates (MIMA) | Melbourne | Florida | 32901-3182 | United States |
| Holmes Regional Medical Center | Melbourne | Florida | 32901 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Parkview Hospital | Fort Wayne | Indiana | 46805-5410 | United States |
| Indiana Neuroscience Institute | Indianapolis | Indiana | 46260 | United States |
| Jewish Hospital Healthcare Services, Inc. | Louisville | Kentucky | 40202 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | United States |
| Nevada Neurosciences Institute at Sunrise | Las Vegas | Nevada | 89109 | United States |
| JFK Medical Center | Edison | New Jersey | 08818 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | United States |
| University of Tennessee, College of Medicine | Chattanooga | Tennessee | 37404 | United States |
| Saint Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| University of Texas, Southwestern Medical Center at Dallas | Dallas | Texas | 75390-8897 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | United States |
| Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| John Hunter Hospital | New Lambton Heights | NSW 2310 | Australia |
| Box Hill Hospital | Victoria | 3128 | Australia |
| Queen Elizabeth Hospital | Woodville | SA 5011 | Australia |
| Medizinische Universitat Graz | Graz | 8036 | Austria |
| Leopold-Franzens-Universitat Innsbruck | Innsbruck | 6020 | Austria |
| O O Landesnervenklinik Wagner-Jauregg | Linz | 4020 | Austria |
| Walter Mackenzie Health Sciences Centre | Edmonton | Alberta | T6G2B7 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z3J5 | Canada |
| Helsinki University Central Hospital | Helsinki | FIN-00029 HUS | Finland |
| Kuopio University Hospital | Kuopio | FIN-70211 | Finland |
| Neurologische Universitatsklinik | Bonn | 53105 | Germany |
| Klinik und Poliklinik der Universitat Leipzig | Leipzig | 04103 | Germany |
| Neurologische Klinik Universitat Ulm | Ulm | 49 (0) 731 500 50986 | Germany |
| University Hospital Amsterdam Department Neurology | Amsterdam | 1105 DD | Netherlands |
| University Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Universitari Doctor Josep Trueta | Girona | 17007 | Spain |
| Fiebach JB, Al-Rawi Y, Wintermark M, Furlan AJ, Rowley HA, Lindsten A, Smyej J, Eng P, Warach S, Pedraza S. Vascular occlusion enables selecting acute ischemic stroke patients for treatment with desmoteplase. Stroke. 2012 Jun;43(6):1561-6. doi: 10.1161/STROKEAHA.111.642322. Epub 2012 Apr 3. |
| 19097942 | Derived | Hacke W, Furlan AJ, Al-Rawi Y, Davalos A, Fiebach JB, Gruber F, Kaste M, Lipka LJ, Pedraza S, Ringleb PA, Rowley HA, Schneider D, Schwamm LH, Leal JS, Sohngen M, Teal PA, Wilhelm-Ogunbiyi K, Wintermark M, Warach S. Intravenous desmoteplase in patients with acute ischaemic stroke selected by MRI perfusion-diffusion weighted imaging or perfusion CT (DIAS-2): a prospective, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2009 Feb;8(2):141-50. doi: 10.1016/S1474-4422(08)70267-9. Epub 2008 Dec 25. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C069588 | salivary plasminogen activator alpha 1, Desmodus rotundus |
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