DIAS-J: Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

Sponsor

Lundbeck Japan K. K. (Industry)

Overall Status

Completed

CT.gov ID

NCT01104467

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Desmoteplase Drug: Desmoteplase Other: Placebo	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [90 days]

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) [90 days]
To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS) [Day 7 and Day 30]
To evaluate recanalisation at 18±6 hr after administration of IMP [18±6 hr after administration of IMP]
To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size [18±6 hr after administration]
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase [0.5 - 9 hr]
To evaluate the immunogenicity of desmoteplase [Day 7, Day 30, Day 90]
To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives [Day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	JP006	Akita	Japan	010-0874
2	JP021	Fukuoka	Japan	810-8563
3	JP018	Hiroshima	Japan	734-8551
4	JP007	Isesaki	Japan	374-0006
5	JP024	Kagoshima	Japan	892-0853
6	JP011	Kawasaki	Japan	216-8511
7	JP015	Kobe	Japan	650-0046
8	JP022	Kumamoto	Japan	861-4193
9	JP012	Nagoya	Japan	466-8650
10	JP026	Nishinomiya	Japan	662-0934
11	JPO17	Okayama	Japan	701-0192
12	JP002	Sapporo,Hokkaido	Japan	006-8555
13	JP001	Sapporo	Japan	060-8570
14	JP004	Sendai	Japan	982-0012
15	JP005	Shibata	Japan	989-1253
16	JP014	Suita	Japan	565-8565
17	JP020	Tokushima	Japan	770-8503
18	JP009	Tokyo	Japan	145-0065
19	JP013	Toyota	Japan	471-8513