Status:
COMPLETED
Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Ministry of Health & Welfare, Korea
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Brief Summary
This study will test the hypothesis whether patients with unclear-onset stroke (UnCLOS) treated with thrombolysis could achieve a prespecified rate of good clinical outcome. The secondary hypothesis i...
Detailed Description
1. Study design: A prospective multicenter trial 2. Study centers: 6 participating medical centers in South Korea 3. Participants: Consecutive patients with acute ischemic stroke visiting the emergenc...
Eligibility Criteria
Inclusion
- The patient is male or female and age between 18 and 85 years
- The patient has unclear onset stroke
- Treatment of the patient can be initiated within 6 hours after first found abnormal time
- The patient has imaging-defined penumbra (at least 20%), measured by diffusion- and perfusion-weighted MRI
Exclusion
- The patient has minor neurologic deficits (NIHSS \<4, except aphasia or hemianopia).
- The patient has rapidly resolving neurological symptoms and the rate of improvement is projected to give the patient an NIHSS score \<4 at the time of treatment.
- The patient has a pre-stroke mRS score of \>1 (indicating previous disability).
- The symptoms of stroke are suggestive of subarachnoid hemorrhage.
- Evidence of infective endocarditis or septic embolism
- The patient has a history or clinical presentation of ICH, SAH, or AVM.
- Serious head trauma within 6 weeks
- Prior ischemic stroke in previous 6 weeks (except small infarct)
- Myocardial infarction in the previous 3 weeks
- Gastrointestinal or urinary tract bleeding in previous 21 days
- Major surgery in the previous 14 days
- History of biopsy of a parenchymal organ, trauma with internal organ injury or lumbar puncture within 14 days
- Arterial puncture at a non-compressible site in the previous 7 days
- Uncontrolled high blood pressure (systolic \> 185 mmHg or diastolic \> 110 mmHg on 3 separate occasions at least 10 min apart despite appropriate treatment)
- Evidence of active bleeding or acute trauma (fracture) on examination
- Current use of oral anticoagulants and a prolonged prothrombin time (INR \>1.7)
- The patient has been treated with heparin in the previous 48 hours with prolonged aPTT, except for low dose subcutaneous LMWH with doses recommended for DVT prophylaxis
- Baseline platelet count \< 100,000 mm3
- Baseline hematocrit \< 25%
- Blood glucose concentration \< 50 mg/dL (2.7 mmol/L) in case of CT screening
- Seizure at onset with postictal residual neurological impairments in case of CT screening
- The patient has a terminal illness.
- The patient is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
- The patient has extensive early infarction in any affected area defined as an infarcted core involving \> 1/3 of MCA territory or the entire ACA or PCA territory
- The patient has well-developed parenchymal hyperintensity on FLAIR, T2\*, or EPI-T2 images, or marked hypodensity on CT, indicative of subacute infarction, or enhancement with morphologic features suggesting the lesion is more than 6 hours old
- The patient has a contraindication to the imaging techniques (this means ferromagnetic objects for MRI, contraindications to contrast agent, renal disease with iodinated contrast agent in perfusion CT and CTA, etc.)
- The patient has imaging evidence of ICH or SAH, AVM, brain tumor (Incidental meningioma and microbleeds are not exclusion criteria. Incidental unruptured aneurysm that is small (\< 5mm) is not an exclusion criterion).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01138059
Start Date
October 1 2006
End Date
June 1 2009
Last Update
June 7 2010
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