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Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)

NCT ID: NCT00638248

Last Updated: 2008-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-10-31

Brief Summary

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The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.

Detailed Description

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Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability in adults. The outcome can be improved by early treatment with thrombolysis. Alteplase (r-tPA) is the only approved thrombolytic drug in the indication of acute ischemic stroke. However, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. As the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile.

Desmoteplase (DSPA) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

Conditions

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Stroke

Keywords

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Acute ischemic stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Desmoteplase 90µg/kg BW

Group Type ACTIVE_COMPARATOR

Desmoteplase

Intervention Type DRUG

Desmoteplase 90µg/kg BW i.v. bolus

2

Desmoteplase 125 µg/kg BW

Group Type ACTIVE_COMPARATOR

Desmoteplase

Intervention Type DRUG

Desmoteplase 125 µg/kg BW i.v. bolus

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo i.v. bolus

Interventions

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Desmoteplase

Desmoteplase 90µg/kg BW i.v. bolus

Intervention Type DRUG

Desmoteplase

Desmoteplase 125 µg/kg BW i.v. bolus

Intervention Type DRUG

Placebo

Placebo i.v. bolus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* scoring 4 to 20 on the National Institute of Health Stroke Scale (NIHSS)
* showing a perfusion-diffusion mismatch on MRI of 20 %
* enrolment within a 3 h to 9 h time window after symptom onset.
* 18-85 years of age

Exclusion Criteria

* Participation in any interventional trial in the previous 30 days.
* Women in the childbearing age.
* Any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm, arteriovenous malformation or aneurysm.
* Conditions that, according to the judgment of the investigator, might impose an additional risk to any individual stroke patient when receiving study medication (this applied to patients on platelet-function inhibitors as well).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PAION Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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PAION Deutschland GmbH

Principal Investigators

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Antony J. Furlan, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology; the Cleveland Clinic Foundation

References

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Furlan AJ, Eyding D, Albers GW, Al-Rawi Y, Lees KR, Rowley HA, Sachara C, Soehngen M, Warach S, Hacke W; DEDAS Investigators. Dose Escalation of Desmoteplase for Acute Ischemic Stroke (DEDAS): evidence of safety and efficacy 3 to 9 hours after stroke onset. Stroke. 2006 May;37(5):1227-31. doi: 10.1161/01.STR.0000217403.66996.6d. Epub 2006 Mar 30.

Reference Type RESULT
PMID: 16574922 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22738918 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22474060 (View on PubMed)

Related Links

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http://stroke.ahajournals.org/cgi/reprint/37/5/1227

Study Publication

Other Identifiers

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PN01-CLD-000002/01

Identifier Type: -

Identifier Source: org_study_id