Back to results

Desmoteplase in Acute Ischemic Stroke (DIAS)

Primary Purpose

Stroke

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Desmoteplase

Placebo

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute ischemic stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).
MRI exclusion criteria: Evidence of ICH, Evidence of SAH, Signs of extensive early infarction on DWI assessed by evidence of involvement of >1/3 of the middle cerebral artery (MCA) territory. No perfusion deficit, Internal carotid artery (ICA) occlusion ipsilateral to stroke lesion without additional ipsilateral MCA, anterior cerebral artery (ACA) or posterior cerebral artery (PCA) occlusion. Any intracranial pathology that would interfere with the MRI assessment of acute ischemic stroke.

Sites / Locations

Prof. Dr. Werner Hacke

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Desmoteplase 62.5 µg/kg BW i.v. bolus

Desmoteplase 90 µg/kg BW i.v. bolus

Desmoteplase 125 µg/kg BW i.v. bolus

Placebo i.v. bolus

Outcomes

Primary Outcome Measures

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

Change in lesion volume

Secondary Outcome Measures

Reperfusion after 4-8 h

Safety and pharmacoeconomic outcomes

Full Information

NCT ID

NCT00638781

First Posted

March 12, 2008

Last Updated

March 12, 2008

Sponsor

PAION Deutschland GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00638781

Brief Title

Desmoteplase in Acute Ischemic Stroke (DIAS)

Official Title

Multicentre, Multinational, Double-Blind, Placebo-Controlled, Randomised Phase II Trial of Desmoteplase (INN) in the Indication of Acute Ischaemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

March 2001 (undefined)

Primary Completion Date

October 2003 (Actual)

Study Completion Date

October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

PAION Deutschland GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Acute ischemic stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Desmoteplase 62.5 µg/kg BW i.v. bolus

Arm Title

Arm Type

Active Comparator

Arm Description

Desmoteplase 90 µg/kg BW i.v. bolus

Arm Title

Arm Type

Active Comparator

Arm Description

Desmoteplase 125 µg/kg BW i.v. bolus

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo i.v. bolus

Intervention Type

Drug

Intervention Name(s)

Desmoteplase

Intervention Description

Desmoteplase 62.5 µg/kg BW

Intervention Type

Drug

Intervention Name(s)

Desmoteplase

Intervention Description

Desmoteplase 90 µg/kg BW

Intervention Type

Drug

Intervention Name(s)

Desmoteplase

Intervention Description

Desmoteplase 125 µg/kg BW

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

Day 90

Title

Change in lesion volume

Time Frame

Day 30

Secondary Outcome Measure Information:

Title

Reperfusion after 4-8 h

Time Frame

8 h

Title

Safety and pharmacoeconomic outcomes

Time Frame

Day 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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). MRI exclusion criteria: Evidence of ICH, Evidence of SAH, Signs of extensive early infarction on DWI assessed by evidence of involvement of >1/3 of the middle cerebral artery (MCA) territory. No perfusion deficit, Internal carotid artery (ICA) occlusion ipsilateral to stroke lesion without additional ipsilateral MCA, anterior cerebral artery (ACA) or posterior cerebral artery (PCA) occlusion. Any intracranial pathology that would interfere with the MRI assessment of acute ischemic stroke.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Werner Hacke, Prof. Dr.

Organizational Affiliation

Head of Neurology Department, University of Heidelberg

Official's Role

Study Chair

Facility Information:

Facility Name

Prof. Dr. Werner Hacke

City

Heidelberg

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

15569863

Citation

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.

Results Reference

result

PubMed Identifier

22738918

Citation

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.

Results Reference

derived

PubMed Identifier

22474060

Citation

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.

Results Reference

derived

Links:

URL

http://www.paion.de

Description

PAION Deutschland GmbH

Learn more about this trial

Desmoteplase in Acute Ischemic Stroke (DIAS)

We'll reach out to this number within 24 hrs