Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-3)
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| ClinicalTrials.gov Identifier: NCT00790920 |
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Recruitment Status :
Completed
First Posted : November 14, 2008
Last Update Posted : September 18, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Drug: Desmoteplase Drug: Placebo | Phase 3 |
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 3-9 hours after onset of stroke symptoms.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 492 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | December 2008 |
| Actual Primary Completion Date : | July 2014 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Desmoteplase |
Drug: Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day |
| Placebo Comparator: Placebo |
Drug: Placebo
IV, single bolus over 1 - 2 minutes on 1st day |
- Modified Rankin Scale Score [ Time Frame: 90 days ]
- National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: 90 days ]
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of acute ischemic stroke
- Informed consent
- Age between 18 and 85 years
- Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
- NIHSS Score of 4-24
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790920
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| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00790920 |
| Other Study ID Numbers: |
12402A 2008-000622-40 ( EudraCT Number ) |
| First Posted: | November 14, 2008 Key Record Dates |
| Last Update Posted: | September 18, 2015 |
| Last Verified: | September 2015 |
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Acute ischemic stroke Angiography Desmoteplase Thrombolytic |
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Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Salivary plasminogen activator alpha 1, Desmodus rotundus Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |