Stroke
- Conditions
- Acute ischemic stroke within 3 - 9 hours after the onset of symptoms.MedDRA version: 14.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2008-005539-14-EE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
• 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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250
• 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 (< 5 mm), not thrombosed, and not visibly bleeding is not an exclusion criterion).
• The subject has an internal carotid artery occlusion on the side of the stroke lesion
• The subject has been treated with heparin in the past 48 hours and has a prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range. Preventive low doses of LMWH (for example, for deep vein thrombosis (DVT) prophylaxis) do not disqualify the subject from the study
• The subject is on oral anticoagulants and has a prolonged prothrombin time (INR > 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 in the past 72 hours been treated with factor Xa inhibitors, direct thrombin inhibitors, or any anticoagulants other than those specified in exclusion criteria 9 and 10.
• The subject has been treated with a thrombolytic agent within the past 72 hours
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method