StrokePhase 2NCT00638781
Desmoteplase in Acute Ischemic Stroke (DIAS)
A Phase 2 study testing Desmoteplase in people with Stroke, run by PAION Deutschland GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Desmoteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2001to Oct 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Multinational, Double-Blind, Placebo-Controlled, Randomised Phase II Trial of Desmoteplase (INN) in the Indication of Acute Ischaemic Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Desmoteplase, Placebo
- Keywords
- Acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmoteplaseDrug
Desmoteplase 62.5 µg/kg BW
DesmoteplaseDrug
Desmoteplase 90 µg/kg BW
DesmoteplaseDrug
Desmoteplase 125 µg/kg BW
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Desmoteplase 62.5 µg/kg BW i.v. bolus Receives: Drug: Desmoteplase |
| 2 | Active comparator | Desmoteplase 90 µg/kg BW i.v. bolus Receives: Drug: Desmoteplase |
| 3 | Active comparator | Desmoteplase 125 µg/kg BW i.v. bolus Receives: Drug: Desmoteplase |
| 4 | Placebo comparator | Placebo i.v. bolus Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS
Measured: Day 90
Change in lesion volume
Measured: Day 30
Secondary outcomes (2)
Reperfusion after 4-8 h
Measured: 8 h
Safety and pharmacoeconomic outcomes
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2001
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAION Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Werner Hacke, Prof. Dr., Study chair, Head of Neurology Department, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638781
- Sponsor's protocol ID
- PN01-CLD-000001/01
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15569863Warach 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.
PubMed 22738918Fiebach 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.
PubMed 22474060
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Multinational, Double-Blind, Placebo-Controlled, Randomised Phase II Trial of Desmoteplase (INN) in the Indication of Acute Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT00638781
- Acronym / sponsor ID
- PN01-CLD-000001/01
- Conditions
- Stroke
- Keywords
- Acute ischemic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- PAION Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DesmoteplaseDesmoteplase 62.5 µg/kg BW i.v. bolus |
| 2 | Active comparator | Drug: DesmoteplaseDesmoteplase 90 µg/kg BW i.v. bolus |
| 3 | Active comparator | Drug: DesmoteplaseDesmoteplase 125 µg/kg BW i.v. bolus |
| 4 | Placebo comparator | Drug: PlaceboPlacebo i.v. bolus |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmoteplaseDesmoteplase 62.5 µg/kg BW | Drug | 1 |
| DesmoteplaseDesmoteplase 90 µg/kg BW | Drug | 2 |
| DesmoteplaseDesmoteplase 125 µg/kg BW | Drug | 3 |
| PlaceboPlacebo | Drug | 4 |
Primary outcome
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS
Time frame: Day 90
Change in lesion volume
Time frame: Day 30
2 secondary outcomes
Reperfusion after 4-8 h
Time frame: 8 h
Safety and pharmacoeconomic outcomes
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
- Results publication: PubMed 15569863Hacke 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.
- Derived from this study: PubMed 22738918Warach 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.
- Derived from this study: PubMed 22474060Fiebach 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Hacke, Prof. Dr. study chair
Head of Neurology Department, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desmoteplase in people with Stroke, run by PAION Deutschland GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (time frame: Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638781, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2008.