Acute Ischemic StrokePhase 2DIAS-JNCT01104467
Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
A Phase 2 study testing Desmoteplase in people with Acute Ischemic Stroke, run by Lundbeck Japan K. K. at 19 sites in Japan.
Trial summary
The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Acute Ischemic 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
- 48 participants
- Where
- 19 sitesJapan
- Study dates
- Aug 2010to Aug 2013
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute ischemic stroke
- Provided Informed Consent
- Male or female
- Aged between 20 and 85 years inclusive
- Treatment within 3-9 hr after onset of stroke symptoms.
- NIHSS score of 4-24 inclusive with clinical signs of hemispheric infarction
- Must receive IMP within 60 minutes after brain imaging
- Cerebral artery occlusion or high-grade stenosis in MCA
Who cannot join
- Pre-stroke mRS score of >1
- Previously exposed to desmoteplase
- Scores >2 on NIHSS question 1a indicating coma
- History or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), moyamoya disease, cerebral neoplasm or aneurysm
- Current use of oral anticoagulants and a prolonged prothrombin time (INR >1.6)
- Treated with heparin in the previous 48 hours and has a prolonged partial thromboplastin time
Show all 20Show fewer
- Baseline platelet count <100,000/mm3
- Baseline haematocrit of <0.25
- Baseline blood glucose <50 mg/dl or >200 mg/dl
- Uncontrolled hypertension defined by a blood pressure, systolic >185 mmHg or diastolic >110 mmHg on at least 2 separate occasions at least 10 minutes apart
- Patient has hereditary or acquired hemorrhagic diathesis
- Gastrointestinal or urinary bleeding within the past 21 days
- Arterial puncture in a non-compressible site within the previous 7 days
- Another stroke or a serious head injury in the past 6 weeks
- Major surgery or serious injury, including other sites than the head, within the preceding 14 days
- Seizure at the onset of stroke
- Acute myocardial infarction (AMI) within the previous 3 weeks
- Thrombolytic within the previous 72 hr
- Pregnant
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
JP006
Akita, 010-0874
JP021
Fukuoka, 810-8563
JP018
Hiroshima, 734-8551
JP007
Isesaki, 374-0006
JP024
Kagoshima, 892-0853
JP011
Kawasaki, 216-8511
JP015
Kobe, 650-0046
JP022
Kumamoto, 861-4193
JP012
Nagoya, 466-8650
JP026
Nishinomiya, 662-0934
JPO17
Okayama, 701-0192
JP001
Sapporo, 060-8570
JP002
Sapporo,Hokkaido, 006-8555
JP004
Sendai, 982-0012
JP005
Shibata, 989-1253
JP014
Suita, 565-8565
JP020
Tokushima, 770-8503
JP009
Tokyo, 145-0065
JP013
Toyota, 471-8513
About this study
Official title: Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke
Read the detailed description
The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses
- Conditions
- Acute Ischemic Stroke
- Being tested
- Desmoteplase, Placebo
- Keywords
- Acute Ischemic Stroke, Desmoteplase, Japan, Safety, Stroke, Tolerability
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmoteplaseDrug
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
DesmoteplaseDrug
1 bolus injection of desmoteplase 90 µg/kg (IV)
PlaceboOther
1 bolus injection of placebo IV
| Study group | Role | What they receive |
|---|---|---|
| Desmoteplase 70 µg/kg | Experimental | Not described Receives: Drug: Desmoteplase |
| Desmoteplase 90 µg/kg | Experimental | Not described Receives: Drug: Desmoteplase |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP
Measured: 90 days
Secondary outcomes (7)
To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS)
Measured: 90 days
To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS)
Measured: Day 7 and Day 30
To evaluate recanalisation at 18±6 hr after administration of IMP
Measured: 18±6 hr after administration of IMP
To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size
Measured: 18±6 hr after administration
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase
Measured: 0.5 - 9 hr
To evaluate the immunogenicity of desmoteplase
Measured: Day 7, Day 30, Day 90
To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives
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 posted15 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionAug 2013
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 Acute Ischemic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundbeck Japan K. K.
- 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
- NCT01104467
- Sponsor's protocol ID
- 11764A
- Acronym
- DIAS-J
- Status last verified
- Aug 2021
- First submitted
- 8 Apr 2010
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mori E, Minematsu K, Nakagawara J, Hasegawa Y, Nagahiro S, Okada Y, Truelsen T, Lindsten A, Ogawa A, Yamaguchi T; DIAS-J Investigators. Safety and Tolerability of Desmoteplase Within 3 to 9 Hours After Symptoms Onset in Japanese Patients With Ischemic Stroke. Stroke. 2015 Sep;46(9):2549-54. doi: 10.1161/STROKEAHA.115.009917. Epub 2015 Aug 6.
PubMed 26251244
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01104467
- Acronym / sponsor ID
- DIAS-J / 11764A
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Desmoteplase, Japan, Safety, Stroke, Tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Lundbeck Japan K. K.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Apr 2010 (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 evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke
Detailed description
The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Desmoteplase 70 µg/kg | Experimental | Drug: Desmoteplase |
| Desmoteplase 90 µg/kg | Experimental | Drug: Desmoteplase |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of acute ischemic stroke
- Provided Informed Consent
- Male or female
- Aged between 20 and 85 years inclusive
- Treatment within 3-9 hr after onset of stroke symptoms.
Key exclusion criteria (20 listed)
- Pre-stroke mRS score of >1
- Previously exposed to desmoteplase
- Scores >2 on NIHSS question 1a indicating coma
- History or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), moyamoya disease, cerebral neoplasm or aneurysm
- Current use of oral anticoagulants and a prolonged prothrombin time (INR >1.6)
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 |
|---|---|---|
| Desmoteplase1 bolus injection of desmoteplase 70 µg/kg intravenous (IV) | Drug | Desmoteplase 70 µg/kg |
| Desmoteplase1 bolus injection of desmoteplase 90 µg/kg (IV) | Drug | Desmoteplase 90 µg/kg |
| Placebo1 bolus injection of placebo IV | Other | Placebo |
Primary outcome
To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP
Time frame: 90 days
7 secondary outcomes
To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS)
Time frame: 90 days
To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS)
Time frame: Day 7 and Day 30
To evaluate recanalisation at 18±6 hr after administration of IMP
Time frame: 18±6 hr after administration of IMP
To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size
Time frame: 18±6 hr after administration
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase
Time frame: 0.5 - 9 hr
To evaluate the immunogenicity of desmoteplase
Time frame: Day 7, Day 30, Day 90
To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives
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 31 Aug 2021.
- Derived from this study: PubMed 26251244Mori E, Minematsu K, Nakagawara J, Hasegawa Y, Nagahiro S, Okada Y, Truelsen T, Lindsten A, Ogawa A, Yamaguchi T; DIAS-J Investigators. Safety and Tolerability of Desmoteplase Within 3 to 9 Hours After Symptoms Onset in Japanese Patients With Ischemic Stroke. Stroke. 2015 Sep;46(9):2549-54. doi: 10.1161/STROKEAHA.115.009917. Epub 2015 Aug 6.
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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
19 sites 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 Acute Ischemic Stroke, run by Lundbeck Japan K. K. at 19 sites in Japan.
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 8 inclusion and 20 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 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. 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?
To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP (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 NCT01104467, 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 31 Aug 2021.