Desmoteplase in Acute Ischemic Stroke (DIAS)

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638781
• Other study ID #: PN01-CLD-000001/01
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2008
• Last updated: March 12, 2008
• Start date: March 2001
• Est. completion date: October 2003

Study information

• Verified date: March 2008
• Source: PAION Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilAustria: Agency for Health and Food SafetyBelgium: Ministry of Social Affairs, Public Health and the EnvironmentFinland: Ministry of Social Affairs and HealthFrance: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencySingapore: Health Sciences AuthoritySpain: Spanish Agency of MedicinesSwitzerland: Federal Office of Public HealthUnited Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Desmoteplase
Desmoteplase 62.5 µg/kg BW
• Desmoteplase
Desmoteplase 90 µg/kg BW
• Desmoteplase
Desmoteplase 125 µg/kg BW
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Prof. Dr. Werner Hacke	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
PAION Deutschland GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS		Day 90	No
Primary	Change in lesion volume		Day 30	No
Secondary	Reperfusion after 4-8 h		8 h	No
Secondary	Safety and pharmacoeconomic outcomes		Day 90	No

External Links

•   Link
•   PAION Deutschland GmbH