NCT00638248

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Mar 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
Last Updated

March 19, 2008

Status Verified

March 1, 2008

Enrollment Period

1.6 years

First QC Date

March 12, 2008

Last Update Submit

March 12, 2008

Conditions

Stroke

Keywords

Acute ischemic stroke

Outcome Measures

Primary Outcomes (4)

  • National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS

    Day 90

  • Reperfusion after 4-8 h

    8 h

  • Infarct lesion volume after 30 days

    Day 30

  • Safety & pharmacokinetic outcomes

    Day 90

Study Arms (3)

1

ACTIVE COMPARATOR

Desmoteplase 90µg/kg BW

Drug: Desmoteplase

2

ACTIVE COMPARATOR

Desmoteplase 125 µg/kg BW

Drug: Desmoteplase

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DesmoteplaseDRUG

Desmoteplase 90µg/kg BW i.v. bolus

1
PlaceboDRUG

Placebo i.v. bolus

3

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • years of age

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 16574922RESULT

  • 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.

    PMID: 22738918DERIVED

  • 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.

    PMID: 22474060DERIVED

Related Links

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

salivary plasminogen activator alpha 1, Desmodus rotundus

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Antony J. Furlan, MD

    Department of Neurology; the Cleveland Clinic Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

March 1, 2003

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

March 19, 2008

Record last verified: 2008-03