Extending the time for thrombolytic treatment after stroke.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 264

Inclusion Criteria

- Patients presenting with acute ischemic stroke
- Patient, family member or legally responsible person depending on local ethics requirements has given informed consent
- Patient?s age is ?18 years
- Treatment onset within ? 4.5 ? 9 hours after stroke onset
- Patients who wake with stroke may be included if neurological and other exclusion criteria are satisfied. These ?wake up? strokes are defined as having no symptoms at sleep onset, but stroke symptoms on waking
- NIHSS score of 4 to 26 with clinical signs of hemispheric infarction
- Penumbral imaging via centralized software system (e.g. RAPID-system) ? Using a Tmax ? 6 second delay, a
perfusion volume (PWI) to infarct core ratio (DWI) of 1.2, and a perfusion lesion minimum volume of 20 ml
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 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

- Intracranial hemorrhage (ICH) identified by CT or MRI
- Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of <4 at randomization
- Pre-stroke mRS score of more than 1 (indicating previous disability)
- Contra indication to imaging with MR
- Infarct core >1/3 MCA territory qualitatively or >100 ml quantitatively (determined by DWI lesion on MR)
- Participation in any investigational study in the previous 30 days
- Any terminal illness such that patient would not be expected to survive more than 3 months
- Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as hemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the investigator
- Pregnant women (clinically evident)
- Previous stroke within last three months
- Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV)
malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator
- Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6) or any aPTT elevation above 1.5 controls or prolonged Thrombin-Time (TT) indicating the potential use of Dabigatran-Etexilate
- Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours
- Use of glycoprotein IIb-IIIa inhibitors within the past 72 hours
- Clinically significant hypoglycemia
- Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of ?aggressive treatment? is left to the discretion of the responsible Investigator.
- Hereditary or acquired hemorrhagic diathesis
- Gastrointestinal or urinary bleeding within the preceding 21 days
- Major surgery within the preceding 14 days which poses risk in the opinion of the investigator
- Exposure to a thrombolytic agent within the previous 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