Acute ischemic stroke within 3 - 9 hours after the onset of symptoms. MedDRA version: 14.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Clinical diagnosis of acute ischemic stroke • Informed consent has been obtained according to a procedure approved by the ethics committee responsible for approval of the study at this site • Male or female between 18 and 85 years of age inclusive. • Treatment of the subject can be initiated within 3-9 hours after the onset of stroke symptoms. If the actual time of onset of stroke is unclear then the onset will be considered the time that the subject was last known to be well. All measures are to be taken, so treatment with alteplase within 3 hours of symptom onset is not delayed in subjects who qualified for receiving alteplase • The subject has a score of 4-24 inclusive on the NIHSS with clinical signs of hemispheric infarction (for example, hemiparesis) • The subject shows occlusion or high-grade stenosis as assessed by MRA or CTA in proximal cerebral arteries that correspond to the acute clinical deficit. Eligible vessels are the Middle Cerebral Artery (MCA) M1, MCA M2, anterior cerebral artery (ACA) or posterior cerebral artery (PCA) • The subject must receive IMP within 60 minutes after completion of diagnostic imaging screening. The time stamp on the last imaging sequence is the reference for calculating the time elapsing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • The subject has a pre-stroke mRS > 1 indicating previously disability • The subject has previously been exposed to desmoteplase • The subject shows signs of extensive early infarction on MRI or CT in any affected area, that is an infarcted core involving > 1/3 of MCA territory or > 1/2 of the ACA or PCA territories • The subject has imaging evidence of ICH or SAH (regardless of age of the bleeding); AV malformation; cerebral aneurysm; or cerebral neoplasm (incidental meningioma and microbleeds per se are not exclusion criteria. An incidental intracranial aneurysm that is small ( 1.6) • The subject has been treated with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors (e.g. low-dose clopidogrel 75 mg or low-dose aspirin =325 mg) or the combination of low-dose-aspirin (e.g. 50 mg) and dipyridamole (e.g. 400 mg) prior to study entry is permitted • The subject has been treated with factor Xa inhibitors in the past 72 hours • The subject has been treated with a thrombolytic agent within the past 72 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of desmoteplase 90 µg/kg versus placebo in terms of favourable outcome at Day 90 in subjects with acute ischemic stroke.;Secondary Objective: • To evaluate the efficacy of 90 µg/kg desmoteplase versus placebo in terms of favourable outcome at Day 7/discharge and Day 30 in subjects with acute ischemic stroke • To evaluate the efficacy of 90 µg/kg desmoteplase versus placebo in terms of favourable outcome at Day 90 in the subgroup of subjects with a baseline core-lesion volume < 25 cc • To evaluate recanalisation associated with 90 µg/kg desmoteplase versus placebo in the subgroup of subjects with follow up angiography at 12-24 hours • To evaluate the safety and tolerability of desmoteplase • To evaluate the mortality in the treatment groups • To evaluate the incidence of symptomatic intracranial haemorrhage (sICH) • To evaluate the immunogenicity of desmoteplase • To evaluate the pharmacokinetics/pharmacodynamics of desmoteplase • To evaluate the impact of treatment on subjects’ quality of life • To evaluate the impact of treatment on utilization of resources ;Primary end point(s): Favourable outcome at Day 90 defined as achieving 0-2 on mRS. | — |
Countries
Belgium, Denmark, Estonia, Finland, Ireland, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed