MedDataX Logo

Desmoteplase in Acute Ischemic Stroke (DIAS)

NCT ID: NCT00638781

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2003-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Acute ischemic stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Desmoteplase 62.5 µg/kg BW i.v. bolus

Group Type ACTIVE_COMPARATOR

Desmoteplase

Intervention Type DRUG

Desmoteplase 62.5 µg/kg BW

2

Desmoteplase 90 µg/kg BW i.v. bolus

Group Type ACTIVE_COMPARATOR

Desmoteplase

Intervention Type DRUG

Desmoteplase 90 µg/kg BW

3

Desmoteplase 125 µg/kg BW i.v. bolus

Group Type ACTIVE_COMPARATOR

Desmoteplase

Intervention Type DRUG

Desmoteplase 125 µg/kg BW

4

Placebo i.v. bolus

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Desmoteplase

Desmoteplase 62.5 µg/kg BW

Intervention Type DRUG

Desmoteplase

Desmoteplase 90 µg/kg BW

Intervention Type DRUG

Desmoteplase

Desmoteplase 125 µg/kg BW

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

PAION Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PAION Deutschland GmbH

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Werner Hacke, Prof. Dr.

Role: STUDY_CHAIR

Head of Neurology Department, University of Heidelberg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prof. Dr. Werner Hacke

Heidelberg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 15569863 (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

Access external resources that provide additional context or updates about the study.

http://stroke.ahajournals.org/cgi/reprint/36/1/66

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PN01-CLD-000001/01

Identifier Type: -

Identifier Source: org_study_id