A study measuring the effect and safety of desmoteplase (the study drug) in patients with a sudden stroke caused by a clot blocking brain blood vessels. Patients have 50% chance getting desmoteplase or placebo (a sugar injection) based on computer-aided random draw and no one involved in the study will know what the patients receive until the whole study is finished.

• Conditions: Acute ischemic stroke within 3 - 9 hours after the onset of symptoms.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 14.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852

• Registration Number: EUCTR2008-000622-40-DE
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-03
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

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

1. The subject has a pre-stroke mRS score of >1,indicating previous disability
2. The subject has previously been exposed to desmoteplase
3. The subject has participated in any investigational study in the past 30 days
4. The subject has a terminal illness with a life-expectancy of less than 6 months
5. In the opinion of the investigator, the subject has any condition that could impose hazards to the subject, if study therapy is initiated, or affect the participation of the subject in the
study (for example, subject with metastatic cancer or with severe microangiopathy such as hemolytic uremic syndrome or thrombotic thrombocytopenic purpura)
6. Consciousness level > 2 on question 1a of NIHSS
7. The subject has a history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous malformation, aneurysm, or cerebral neoplasm. Subjects with
incidental small intracranial aneurysm can be considered for the study if the aneurysm is < 5 mm, not thrombosed, and not visibly bleeding
8. The subject has symptomatic acute vertebral or basilar artery occlusion
9. The subject is on oral anticoagulants and has a prolonged prothrombin time (INR > 1.6)
10. 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.
11. The subject has been treated with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors (e.g. 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.
12. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified