Trial record 2 of 6 for:
Desmoteplase in subjects with Acute Ischemic Stroke
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
This study is currently recruiting participants.
Verified April 2013 by H. Lundbeck A/S
Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00856661
First received: March 5, 2009
Last updated: April 13, 2013
Last verified: April 2013
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Purpose
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: Desmoteplase Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-Blind, Parallel-Group Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke |
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Modified Rankin Scale Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Desmoteplase |
Drug: Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day
|
| Placebo Comparator: Placebo |
Drug: Placebo
IV, single bolus over 1 to 2 minutes on 1st day
|
Detailed Description:
Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.
The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3 to 9 hours after onset of stroke symptoms.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of acute ischemic stroke
- Informed consent
- Age between 18 and 85 years
- Treatment can be initiated within 3 to 9 hours after the onset of stroke symptoms
- NIHSS Score of 4 to 24
- Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries
Exclusion Criteria:
- Pre-stroke mRS >1
- Previous exposure to desmoteplase
- Extensive early infarction on MRI or CT in any affected area
- Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
- Internal carotid artery occlusion on the side of the stroke lesion
- Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
- Treatment with oral anticoagulants and a prolonged prothrombin time
- Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
- Treatment with a thrombolytic agent within the past 72 hours
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856661
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Contacts
| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Hide Study LocationsLocations
| United States, Arizona | |
| US053 | Terminated |
| Phoenix, Arizona, United States, 85054 | |
| United States, California | |
| US081 | Terminated |
| Castro Valley, California, United States, 94546 | |
| US089 | Not yet recruiting |
| La Jolla, California, United States, 92037 | |
| US043 | Completed |
| Loma Linda, California, United States, 92354 | |
| US008 | Not yet recruiting |
| Los Angeles, California, United States, 90024-1777 | |
| US020 | Not yet recruiting |
| Palo Alto, California, United States, 94304 | |
| US050 | Recruiting |
| Pasadena, California, United States, 91105 | |
| US098 | Not yet recruiting |
| Santa Barbara, California, United States, 93105 | |
| US051 | Not yet recruiting |
| Thousand Oaks, California, United States, 91360 | |
| United States, Colorado | |
| US068 | Terminated |
| Englewood, Colorado, United States, 80113 | |
| United States, Connecticut | |
| US063 | Not yet recruiting |
| Fairfield, Connecticut, United States, 06824 | |
| US104 | Not yet recruiting |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| US049 | Terminated |
| Pensacola, Florida, United States, 32504 | |
| United States, Georgia | |
| US109 | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| US042 | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| US052 | Not yet recruiting |
| Columbus, Georgia, United States, 31902 | |
| US080 | Terminated |
| Decatur, Georgia, United States, 30033 | |
| US040 | Terminated |
| Lawrenceville, Georgia, United States, 30045 | |
| US067 | Terminated |
| Macon, Georgia, United States, 31201 | |
| US085 | Terminated |
| Savannah, Georgia, United States, 31405 | |
| US086 | Completed |
| Savannah, Georgia, United States, 31419 | |
| United States, Illinois | |
| US044 | Not yet recruiting |
| Chicago, Illinois, United States, 60622 | |
| US093 | Terminated |
| Chicago, Illinois, United States, 60611 | |
| US101 | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| US074 | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| US073 | Not yet recruiting |
| Glenview, Illinois, United States, 60026 | |
| US091 | Not yet recruiting |
| Maywood, Illinois, United States, 60153 | |
| US088 | Completed |
| Oak Lawn, Illinois, United States, 60453 | |
| United States, Indiana | |
| US016 | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| US072 | Recruiting |
| Des Moines, Iowa, United States, 50314-2611 | |
| United States, Louisiana | |
| US061 | Not yet recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| US108 | Not yet recruiting |
| New Orleans, Louisiana, United States, 70121 | |
| US064 | Not yet recruiting |
| Shreveport, Louisiana, United States, 71130-3932 | |
| United States, Maryland | |
| US014 | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| US039 | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| US003 | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| US017 | Completed |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| US066 | Terminated |
| Detroit, Michigan, United States, 48201 | |
| US083 | Not yet recruiting |
| Detroit, Michigan, United States, 48236 | |
| US096 | Not yet recruiting |
| Detroit, Michigan, United States, 48202 | |
| US060 | Completed |
| Grand Blanc, Michigan, United States, 48439 | |
| US078 | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| US103 | Not yet recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| US056 | Terminated |
| Petoskey, Michigan, United States, 49770 | |
| US113 | Not yet recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| US113 | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| US076 | Not yet recruiting |
| Southfield, Michigan, United States, 48075 | |
| US082 | Not yet recruiting |
| Southfield, Michigan, United States, 48075 | |
| US079 | Not yet recruiting |
| Troy, Michigan, United States, 48085 | |
| United States, Mississippi | |
| US059 | Terminated |
| Gulfport, Mississippi, United States, 39502 | |
| United States, Missouri | |
| US048 | Terminated |
| Springfield, Missouri, United States, 65807 | |
| United States, New Hampshire | |
| US077 | Recruiting |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| US055 | Recruiting |
| Edison, New Jersey, United States, 08818 | |
| US115 | Not yet recruiting |
| Neptune, New Jersey, United States, 07753 | |
| US100 | Recruiting |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| US075 | Recruiting |
| Albany, New York, United States, 12208 | |
| US102 | Not yet recruiting |
| Brooklyn, New York, United States, 11220 | |
| US012 | Recruiting |
| Buffalo, New York, United States, 14203 | |
| US026 | Terminated |
| Stony Brook, New York, United States, 11794-8121 | |
| United States, North Carolina | |
| US037 | Recruiting |
| Greensboro, North Carolina, United States, 27401 | |
| US069 | Terminated |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| US038 | Terminated |
| Cleveland, Ohio, United States, 44109 | |
| US001 | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| US062 | Terminated |
| Columbus, Ohio, United States, 43214 | |
| US046 | Not yet recruiting |
| Toledo, Ohio, United States, 43614 | |
| United States, Oregon | |
| US095 | Not yet recruiting |
| Springfield, Oregon, United States, 97477 | |
| United States, Pennsylvania | |
| US070 | Terminated |
| Allentown, Pennsylvania, United States, 18103 | |
| US023 | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19141 | |
| US084 | Recruiting |
| Pittsburg, Pennsylvania, United States, 15213 | |
| US099 | Not yet recruiting |
| Pittsburg, Pennsylvania, United States, 15212 | |
| United States, Rhode Island | |
| US092 | Terminated |
| Providence, Rhode Island, United States, 02903 | |
| US087 | Not yet recruiting |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| US057 | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| United States, Tennessee | |
| US019 | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| US058 | Recruiting |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| US021 | Recruiting |
| Houston, Texas, United States, 77030 | |
| US031 | Terminated |
| Houston, Texas, United States, 77030 | |
| US112 | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| US047 | Terminated |
| Richmond, Virginia, United States, 23298 | |
| US006 | Completed |
| Winchester, Virginia, United States, 22601 | |
| United States, Wisconsin | |
| US011 | Completed |
| Madison, Wisconsin, United States, 53792 | |
| US097 | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Belgium | |
| BE008 | Not yet recruiting |
| Brugge, Belgium, 8000 | |
| BE004 | Terminated |
| Hasselt, Belgium, 3500 | |
| BE005 | Terminated |
| Roeselare, Belgium, 8800 | |
| BE006 | Terminated |
| Wilrijk, Belgium, 2610 | |
| Brazil | |
| BR012 | Recruiting |
| Campinas, Brazil, 13083-970 | |
| BR004 | Terminated |
| Porto Alegre, Brazil, 90020-090 | |
| BR007 | Recruiting |
| Porto Alegre, Brazil, 90110-270 | |
| BR008 | Recruiting |
| Porto Alegre, Brazil, 90035-003 | |
| BR009 | Recruiting |
| Rio de Janeiro, Brazil, 20941-150 | |
| BR011 | Recruiting |
| Rio de Janeiro, Brazil, 22280-000 | |
| BR006 | Recruiting |
| Salvador, Brazil, 40140-110 | |
| Canada, Alberta | |
| CA001 | Recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada | |
| CA004 | Recruiting |
| Edmonton, Canada, T6L 5X8 | |
| CA006 | Terminated |
| Halifax, Canada, B3H 3A7 | |
| CA008 | Not yet recruiting |
| Mississauga, Canada, L5B 1B8 | |
| CA007 | Not yet recruiting |
| Ottawa, Canada, K1Y 4E9 | |
| CA002 | Recruiting |
| Toronto, Canada, M5T 2S8 | |
| CA012 | Recruiting |
| Toronto, Canada, M4N 3M5 | |
| CA005 | Recruiting |
| Victoria, Canada, V8R 1J8 | |
| Chile | |
| CL006 | Terminated |
| Santiago, Chile | |
| CL003 | Terminated |
| Santiago, Chile | |
| CL002 | Completed |
| Santiago, Chile | |
| CL004 | Completed |
| Santiago, Chile | |
| CL005 | Completed |
| Valparaiso, Chile | |
| Denmark | |
| DK002 | Completed |
| Aalborg, Denmark, 9000 | |
| DK001 | Recruiting |
| Aarhus, Denmark, 8000 | |
| DK004 | Recruiting |
| Copenhagen NV, Denmark, 2400 | |
| DK003 | Completed |
| Glostrup, Denmark, 2600 | |
| Finland | |
| FI001 | Recruiting |
| Helsinki, Finland, 29 | |
| FI002 | Terminated |
| Tampere, Finland, 33520 | |
| FI003 | Recruiting |
| Turku, Finland, 20520 | |
| Ireland | |
| IE001 | Terminated |
| Dublin, Ireland, 8 | |
| Italy | |
| IT010 | Completed |
| Ancona, Italy, 60020 | |
| IT008 | Completed |
| Brescia, Italy, 25123 | |
| IT003 | Completed |
| Firenze, Italy, 50019 | |
| IT004 | Recruiting |
| Imperia, Italy, 18100 | |
| IT002 | Completed |
| Milano, Italy, 20132 | |
| IT006 | Completed |
| Milano, Italy, 20153 | |
| IT009 | Completed |
| Milano, Italy, 20162 | |
| IT012 | Recruiting |
| Modena, Italy, 41100 | |
| IT001 | Recruiting |
| Rome, Italy, 161 | |
| IT005 | Recruiting |
| Rome, Italy, 189 | |
| IT007 | Completed |
| Rozzano, Italy, 20089 | |
| IT011 | Recruiting |
| Verona, Italy, 37126 | |
| Mexico | |
| MX002 | Recruiting |
| D.f., Mexico, 14269 | |
| MX003 | Recruiting |
| Mexico City, Mexico, 14000 | |
| MX004 | Active, not recruiting |
| Mexico City, Mexico, 14050 | |
| MX005 | Recruiting |
| Monterrey Nuevo Leon, Mexico | |
| Norway | |
| NO003 | Completed |
| Bergen, Norway, 2021 | |
| NO001 | Completed |
| Oslo, Norway, 0027 | |
| NO002 | Completed |
| Trondheim, Norway, 7006 | |
| South Africa | |
| ZA003 | Terminated |
| Cape Town, South Africa, 7130 | |
| ZA001 | Terminated |
| Cape Town, South Africa, 7800 | |
| ZA002 | Completed |
| Cape Town, South Africa, 7405 | |
| Sweden | |
| SE002 | Completed |
| Lund, Sweden, 221 85 | |
| SE001 | Completed |
| Malmø, Sweden, 205 02 | |
| United Kingdom | |
| GB012 | Not yet recruiting |
| Belfast, United Kingdom, BT12 6BJ | |
| GB004 | Recruiting |
| Christchurch, United Kingdom, BH23 2JX | |
| GB010 | Recruiting |
| Dundee, United Kingdom, DD1 9SY | |
| GB002 | Recruiting |
| Exeter, United Kingdom, EX2 5DW | |
| GB007 | Recruiting |
| Glasgow, United Kingdom, G51 4TF | |
| GB009 | Recruiting |
| Glasgow, United Kingdom, G11 6NT | |
| GB011 | Recruiting |
| Liverpool, United Kingdom, L7 8XP | |
| GB003 | Recruiting |
| London, United Kingdom, SW17 0RE | |
| GB006 | Recruiting |
| London, United Kingdom, SE5 8AF | |
| GB001 | Recruiting |
| Newcastle upon Tyne, United Kingdom, NE1 4LP | |
| GB016 | Not yet recruiting |
| Nottingham, United Kingdom, NG5 1PB | |
| GB014 | Not yet recruiting |
| Sheffield, United Kingdom, S10 2JF | |
| GB005 | Recruiting |
| Stoke on Trent, United Kingdom, ST4 6QG | |
| GB015 | Recruiting |
| Westcliff-on-Sea, United Kingdom, SS0 0RY | |
| GB013 | Recruiting |
| Wolverhampton, United Kingdom, WV10 0QP | |
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00856661 History of Changes |
| Other Study ID Numbers: | 12649A, 2008-005539-14 |
| Study First Received: | March 5, 2009 |
| Last Updated: | April 13, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Belgium: Federal Agency for Medicinal Products and Health Products Brazil: Ministry of Health Canada: Health Canada Chile: Comisión Nacional de Investigación Científica y Tecnológica Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Ireland: Irish Medicines Board Italy: The Italian Medicines Agency Mexico: Ministry of Health Norway: Norwegian Medicines Agency South Africa: Medicines Control Council Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by H. Lundbeck A/S:
|
Acute ischemic stroke Angiography Desmoteplase Thrombolytic |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Salivary plasminogen activator alpha 1, Desmodus rotundus Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013