StrokePhase 3DIAS-3NCT00790920
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
A Phase 3 study testing Desmoteplase in people with Stroke, run by H. Lundbeck A/S at 102 sites in 17 countries.
Trial summary
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms. 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
- 492 participants
- Where
- 102 sitesin 17 countries
- Study dates
- Dec 2008to Jul 2014
- Phase
- Phase 3
- 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
- Diagnosis of acute ischemic stroke
- Informed consent
- Age between 18 and 85 years
- Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
- NIHSS Score of 4-24
- Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries
Who cannot join
- Pre-stroke mRS >1
- Previous exposure to desmoteplase
- Extensive early infarction on MRI or CT in any affected area
- Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
- Internal carotid artery occlusion on the side of the stroke lesion
- Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
Show all 9Show fewer
- Treatment with oral anticoagulants and a prolonged prothrombin time
- Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
- Treatment with a thrombolytic agent within the past 72 hours
Trial locations and contacts
102 sites in 17 countries.
102 sites in 17 countries
Germany13 sites
DE002
Berlin, 12200
DE001
Dresden, 1307
DE011
Erlangen, 91054
DE005
Freiburg im Breisgau, 79104
DE018
Hamburg, 20246
DE020
Hanover, 30625
DE019
Jena, 7747
DE003
Leipzig, 4103
DE022
Lübeck
DE021
Neuruppin, 16816
DE025
Rostock, 18147
DE012
Schweinfurt, 97422
DE016
Würzburg, 97080
South Korea13 sites
KR013
Ansan-si, 425 707
KR003
Anyang, 431 070
KR006
Busan, 602-715
KR011
Daegu
KR002
Incheon, 400-711
KR010
Kwangju, 501757
KR008
Seongnam, 463-707
KR004
Seoul, 120-752
KR001
Seoul, 137-710
KR012
Seoul, 139711
KR009
Seoul, 156707
KR005
Seoul
KR007
Wŏnju, 220-701
France12 sites
FR004
Besançon, 25000
FR013
Bordeaux, 33076
FR003
Bourg-en-Bresse, 1012
FR015
Caen, 14033
FR014
Lille, 59037
FR012
Limoges, 87042
FR008
Montpellier, 34295
FR010
Nice, 6000
FR001
Paris, 75010
FR009
Paris, 75014
FR007
Perpignan, 66046
FR016
Toulouse, 31059
Spain11 sites
ES010
Albacete, 2006
ES012
Alcázar de San Juan, 13600
ES007
Barcelona, 8907
ES003
Barcelona, 8916
ES014
Bilbao, 48013
ES004
Girona, 17007
ES013
Lugo, 27003
ES011
Madrid, 28034
ES005
Madrid, 28040
ES008
Madrid, 75010
ES006
Valladolid, 47005
Taiwan9 sites
TW003
Kaohsiung City, 807
TW001
Kaohsiung City, 833
TW006
Taichung, 40447
TW005
Tainan, 704
TW008
Tainan, 710
TW009
Taipei, 100
TW007
Taipei, 10449
TW002
Taipei
TW004
Taoyuan, 333
Australia6 sites
AU006
Clayton, 3168
AU004
Gosford, 2250
AU001
Melbourne
AU002
Melbourne
AU003
Newcastle
AU009
Perth, 6000
India6 sites
IN004
Chandigarh, 160012
IN009
Guntur, 522001
IN008
Hyderabad, 500001
IN003
Hyderabad, 500082
IN007
Ludhiana, 141008
IN001
Pune, 411001
Thailand6 sites
TH003
Bangkok, 10330
TH002
Bangkok, 10400
TH006
Bangkok, 10400
TH004
Bangkok, 10700
TH005
Chiang Mai, 50200
TH001
Pathum Thani, 12120
Austria5 sites
AT003
Graz, 8036
AT004
Innsbruck, 6020
AT002
Linz, 4020
AT001
Linz, 4021
AT005
Vienna, 1090
Poland5 sites
PL004
Gdansk, 80952
PL005
Lublin, 29950
PL006
Sandomierz, 27600
PL001
Warsaw, 02-957
PL002
Warsaw, 02-957
Estonia4 sites
EE002
Tallinn, 10138
EE004
Tallinn, 10617
EE003
Tallinn, 13419
EE001
Tartu, 51014
About this study
Official title: A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.
Read the detailed description
Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.
The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.
- Conditions
- Stroke
- Being tested
- Desmoteplase, Placebo
- Keywords
- Acute ischemic stroke, Angiography, Desmoteplase, Thrombolytic
- 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
90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
PlaceboDrug
IV, single bolus over 1 - 2 minutes on 1st day
| Study group | Role | What they receive |
|---|---|---|
| Desmoteplase | Experimental | Not described Receives: Drug: Desmoteplase |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale Score
Measured: 90 days
Secondary outcomes (1)
National Institutes of Health Stroke Scale (NIHSS) Score
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790920
- Sponsor's protocol ID
- 12402A
- Other IDs
- 2008-000622-40, 2008
- Acronym
- DIAS-3
- Status last verified
- Sep 2015
- First submitted
- 13 Nov 2008
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Albers GW, von Kummer R, Truelsen T, Jensen JK, Ravn GM, Gronning BA, Chabriat H, Chang KC, Davalos AE, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A; DIAS-3 Investigators. Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Neurol. 2015 Jun;14(6):575-84. doi: 10.1016/S1474-4422(15)00047-2. Epub 2015 Apr 30.
PubMed 25937443
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00790920
- Acronym / sponsor ID
- DIAS-3 / 12402A
- Conditions
- Stroke
- Keywords
- Acute ischemic stroke, Angiography, Desmoteplase, Thrombolytic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2014 (actual)
- First posted
- 14 Nov 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 purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.
Detailed description
Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.
The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmoteplase | Experimental | Drug: Desmoteplase |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of acute ischemic stroke
- Informed consent
- Age between 18 and 85 years
- Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
- NIHSS Score of 4-24
Key exclusion criteria (9 listed)
- Pre-stroke mRS >1
- Previous exposure to desmoteplase
- Extensive early infarction on MRI or CT in any affected area
- Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
- Internal carotid artery occlusion on the side of the stroke lesion
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 |
|---|---|---|
| Desmoteplase90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day | Drug | Desmoteplase |
| PlaceboIV, single bolus over 1 - 2 minutes on 1st day | Drug | Placebo |
Primary outcome
Modified Rankin Scale Score
Time frame: 90 days
1 secondary outcome
National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: 90 days
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 18 Sep 2015.
- Derived from this study: PubMed 25937443Albers GW, von Kummer R, Truelsen T, Jensen JK, Ravn GM, Gronning BA, Chabriat H, Chang KC, Davalos AE, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A; DIAS-3 Investigators. Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Neurol. 2015 Jun;14(6):575-84. doi: 10.1016/S1474-4422(15)00047-2. Epub 2015 Apr 30.
- EMA EudraCT Result PostingLink provided by the sponsor.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
102 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmoteplase in people with Stroke, run by H. Lundbeck A/S at 102 sites in 17 countries.
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 6 inclusion and 9 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 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in Germany, South Korea, France, Spain, Taiwan and 12 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Modified Rankin Scale Score (time frame: 90 days). 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 NCT00790920, which also lists 1 linked publication.
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 18 Sep 2015.