NCT00638781

Brief Summary

The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Mar 2001

Geographic Reach
1 country

1 active site

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, 2001

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.4 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

2.6 years

First QC Date

March 12, 2008

Last Update Submit

March 12, 2008

Conditions

Stroke

Keywords

Acute ischemic stroke

Outcome Measures

Primary Outcomes (2)

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

    Day 90

  • Change in lesion volume

    Day 30

Secondary Outcomes (2)

  • Reperfusion after 4-8 h

    8 h

  • Safety and pharmacoeconomic outcomes

    Day 90

Study Arms (4)

1

ACTIVE COMPARATOR

Desmoteplase 62.5 µg/kg BW i.v. bolus

Drug: Desmoteplase

2

ACTIVE COMPARATOR

Desmoteplase 90 µg/kg BW i.v. bolus

Drug: Desmoteplase

3

ACTIVE COMPARATOR

Desmoteplase 125 µg/kg BW i.v. bolus

Drug: Desmoteplase

4

PLACEBO COMPARATOR

Placebo i.v. bolus

Drug: Placebo

Interventions

DesmoteplaseDRUG

Desmoteplase 62.5 µg/kg BW

1
PlaceboDRUG

Placebo

4

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

Study Sites (1)

Prof. Dr. Werner Hacke

Heidelberg, Germany

Location

Related Publications (3)

  • Hacke W, Albers G, Al-Rawi Y, Bogousslavsky J, Davalos A, Eliasziw M, Fischer M, Furlan A, Kaste M, Lees KR, Soehngen M, Warach S; DIAS Study Group. The Desmoteplase in Acute Ischemic Stroke Trial (DIAS): a phase II MRI-based 9-hour window acute stroke thrombolysis trial with intravenous desmoteplase. Stroke. 2005 Jan;36(1):66-73. doi: 10.1161/01.STR.0000149938.08731.2c. Epub 2004 Nov 29.

    PMID: 15569863RESULT

  • 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

  • Werner Hacke, Prof. Dr.

    Head of Neurology Department, University of Heidelberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
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, 2001

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

March 19, 2008

Record last verified: 2008-03

Locations

DE(1)