Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke (DIAS-J)
This study is currently recruiting participants.
Verified March 2013 by Lundbeck Japan K. K.
Sponsor:
Lundbeck Japan K. K.
Information provided by (Responsible Party):
Lundbeck Japan K. K.
ClinicalTrials.gov Identifier:
NCT01104467
First received: April 8, 2010
Last updated: March 15, 2013
Last verified: March 2013
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Purpose
The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Ischemic Stroke |
Drug: Desmoteplase Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke |
Further study details as provided by Lundbeck Japan K. K.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To evaluate recanalisation at 18±6 hr after administration of IMP [ Time Frame: 18±6 hr after administration of IMP ] [ Designated as safety issue: No ]
- To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size [ Time Frame: 18±6 hr after administration ] [ Designated as safety issue: No ]
- To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase [ Time Frame: 0.5 - 9 hr ] [ Designated as safety issue: No ]
- To evaluate the immunogenicity of desmoteplase [ Time Frame: Day 7, Day 30, Day 90 ] [ Designated as safety issue: No ]
- To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Desmoteplase 70 µg/kg |
Drug: Desmoteplase
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
|
| Experimental: Desmoteplase 90 µg/kg |
Drug: Desmoteplase
1 bolus injection of desmoteplase 90 µg/kg (IV)
|
| Placebo Comparator: Placebo |
Other: Placebo
1 bolus injection of placebo IV
|
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
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104467
Contacts
| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Locations
| Japan | |
| JP006 | Recruiting |
| Akita, Japan, 010-0874 | |
| JP021 | Recruiting |
| Fukuoka, Japan, 810-8563 | |
| JP018 | Recruiting |
| Hiroshima, Japan, 734-8551 | |
| JP007 | Recruiting |
| Isesaki, Japan, 374-0006 | |
| JP024 | Recruiting |
| Kagoshima, Japan, 892-0853 | |
| JP011 | Recruiting |
| Kawasaki, Japan, 216-8511 | |
| JP015 | Recruiting |
| Kobe, Japan, 650-0046 | |
| JP022 | Recruiting |
| Kumamoto, Japan, 861-4193 | |
| JP012 | Recruiting |
| Nagoy, Japan, 466-8650 | |
| JP026 | Recruiting |
| Nishinomiya, Japan, 662-0934 | |
| JPO17 | Recruiting |
| Okayama, Japan, 701-0192 | |
| JP001 | Recruiting |
| Sapporo, Japan, 060-8570 | |
| JP002 | Recruiting |
| Sapporo,Hokkaido, Japan, 006-8555 | |
| JP004 | Recruiting |
| Sendai, Japan, 982-0012 | |
| JP005 | Recruiting |
| Shibata, Japan, 989-1253 | |
| JP014 | Recruiting |
| Suita, Japan, 565-8565 | |
| JP020 | Recruiting |
| Tokushima, Japan, 770-8503 | |
| JP009 | Recruiting |
| Tokyo, Japan, 145-0065 | |
| JP013 | Recruiting |
| Toyota, Japan, 471-8513 | |
Sponsors and Collaborators
Lundbeck Japan K. K.
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
No publications provided
| Responsible Party: | Lundbeck Japan K. K. |
| ClinicalTrials.gov Identifier: | NCT01104467 History of Changes |
| Other Study ID Numbers: | 11764A |
| Study First Received: | April 8, 2010 |
| Last Updated: | March 15, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Lundbeck Japan K. K.:
|
Acute Ischemic Stroke Desmoteplase Japan |
Safety Stroke Tolerability |
Additional relevant MeSH terms:
|
Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Salivary plasminogen activator alpha 1, Desmodus rotundus Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013