Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01104467
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT01104467
Study Brief:
Protocol Section:
NCT01104467