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Desmoteplase in Acute Ischemic Stroke (DIAS)

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00638781
Enrollment
104
Registered
2008-03-19
Start date
2001-03-31
Completion date
2003-10-31
Last updated
2008-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Acute ischemic stroke

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.

Interventions

Desmoteplase 62.5 µg/kg BW

DRUGPlacebo

Placebo

Sponsors

PAION Deutschland GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRSDay 90
Change in lesion volumeDay 30

Secondary

MeasureTime frame
Reperfusion after 4-8 h8 h
Safety and pharmacoeconomic outcomesDay 90

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026