Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)

• Sponsor: Forest Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00111852
• Collaborator: (none)
• Enrollment: 193
• Locations: 44
• Arms: 3
• Patients Per Site: 4.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Drug: Desmoteplase; Drug: Desmoteplase; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Single Bolus, Multinational, Multi-center, Parallel Group, Dose-ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desmoteplase, low dose Desmoteplase 90 mcg/kg, intravenous administration.	Drug: Desmoteplase; Desmoteplase 90 mcg/kg, intravenous administration.
Experimental: Desmoteplase, high dose Desmoteplase 125 mcg/kg, intravenous administration.	Drug: Desmoteplase; Desmoteplase 125 mcg/kg, intravenous administration.
Placebo Comparator: Placebo Dose-Match Placebo, intravenous administration.	Drug: Placebo; Dose-Match Placebo, intravenous administration.

Outcome Measures

Primary Outcome Measures

1. National Institutes of Health Stroke Scale (NIHSS) [Change from Baseline to day 90]

   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).

2. Modified Rankin Scale (MRS) [Day 90]

   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).

3. Barthel Index (BI) score of 75-100. [Day 90]

   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)

Secondary Outcome Measures

1. Percentage of patients with improvement in NIHSS score [From Baseline to Day 90]

   Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1.

2. Percentage of patients with MRS score of 0-2 [Day 90]

3. Percentage of patients with BI score of 75-100 [Day 90]

4. Infarct Volume [Change from baseline to Day 30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eligible for study treatment within 3-9 hours after onset of stroke symptoms.

• Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke.

Inclusion Criteria from diagnostic imaging screening:

• Distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related to middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory in a hemispheric distribution.

Exclusion Criteria:

• History or clinical presentation of intracranial hemorrhage (ICH), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm.

• Rapidly improving neurological symptoms.

• Pre-stroke MRS score of > 1 (including previous disability).

• Suspected acute vertebral or basilar artery occlusion.

• Current use of anticoagulants and a prolonged prothrombin time.

• Uncontrolled hypertension.

• Baseline hematocrit of < 0.25.

• Baseline platelet count < 100,000/mm3.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Neurological Institute, Dept. of Neurology	Birmingham	Alabama	United States	35209
2	University of California Los Angeles Medical Center	Los Angeles	California	United States	90024-1777
3	Brain Matters, Inc.	Delray Beach	Florida	United States	33445
4	Melbourne Internal Medicine Associates (MIMA)	Melbourne	Florida	United States	32901-3182
5	Holmes Regional Medical Center	Melbourne	Florida	United States	32901
6	Tampa General Hospital	Tampa	Florida	United States	33606
7	Loyola University Medical Center	Maywood	Illinois	United States	60153
8	Parkview Hospital	Fort Wayne	Indiana	United States	46805-5410
9	Indiana Neuroscience Institute	Indianapolis	Indiana	United States	46260
10	Jewish Hospital Healthcare Services, Inc.	Louisville	Kentucky	United States	40202
11	University of Louisville Hospital	Louisville	Kentucky	United States	40202
12	Johns Hopkins University	Baltimore	Maryland	United States	21287
13	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
14	Boston University Medical Center	Boston	Massachusetts	United States	02118
15	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts	United States	02215
16	Nevada Neurosciences Institute at Sunrise	Las Vegas	Nevada	United States	89109
17	JFK Medical Center	Edison	New Jersey	United States	08818
18	Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
19	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
20	The Ohio State University Medical Center	Columbus	Ohio	United States	43210
21	Erlanger Health System	Chattanooga	Tennessee	United States	37403
22	University of Tennessee, College of Medicine	Chattanooga	Tennessee	United States	37404
23	Saint Thomas Hospital	Nashville	Tennessee	United States	37205
24	University of Texas, Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390-8897
25	The Methodist Hospital	Houston	Texas	United States	77030
26	University of Utah Medical Center	Salt Lake City	Utah	United States	84132
27	Winchester Medical Center	Winchester	Virginia	United States	22601
28	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
29	John Hunter Hospital	New Lambton Heights		Australia	NSW 2310
30	Box Hill Hospital	Victoria		Australia	3128
31	Queen Elizabeth Hospital	Woodville		Australia	SA 5011
32	Medizinische Universitat Graz	Graz		Austria	8036
33	Leopold-Franzens-Universitat Innsbruck	Innsbruck		Austria	6020
34	O O Landesnervenklinik Wagner-Jauregg	Linz		Austria	4020
35	Walter Mackenzie Health Sciences Centre	Edmonton	Alberta	Canada	T6G2B7
36	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z3J5
37	Helsinki University Central Hospital	Helsinki		Finland	FIN-00029 HUS
38	Kuopio University Hospital	Kuopio		Finland	FIN-70211
39	Neurologische Universitatsklinik	Bonn		Germany	53105
40	Klinik und Poliklinik der Universitat Leipzig	Leipzig		Germany	04103
41	Neurologische Klinik Universitat Ulm	Ulm		Germany	49 (0) 731 500 50986
42	University Hospital Amsterdam Department Neurology	Amsterdam		Netherlands	1105 DD
43	University Hospital Germans Trias i Pujol	Badalona		Spain	08916
44	Hospital Universitari Doctor Josep Trueta	Girona		Spain	17007

Sponsors and Collaborators

• Forest Laboratories

Investigators

• Study Director: Leslie Lipka, MD, Forest Laboratories

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Forest Laboratories
• ClinicalTrials.gov Identifier: NCT00111852
• Other Study ID Numbers: DSP-MD-01
• First Posted: May 27, 2005
• Last Update Posted: Mar 20, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Forest Laboratories: Desmoteplase; Acute Ischemic Stroke; Stroke, Acute
• Additional relevant MeSH terms: Stroke; Salivary plasminogen activator alpha 1, Desmodus rotundus

Study Results

No Results Posted as of Mar 20, 2012