Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset (RESTORE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01138059 |
Recruitment Status
:
Completed
First Posted
: June 7, 2010
Last Update Posted
: June 7, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Stroke |
- Study design: A prospective multicenter trial
- Study centers: 6 participating medical centers in South Korea
- Participants: Consecutive patients with acute ischemic stroke visiting the emergency room within 6 hours of the detection of stroke symptoms
-
Methods
-
3 thrombolysis protocols applicable to UnCLOS patients
- IV tissue plasminogen activator (tPA) : Conventional intravenous tPA (0.9 mg/kg, 10% of the dose as a bolus and the remainder over 60 minutes) will be administered to patients within 3 hours of first found abnormal time who had no arterial occlusion or catheter-inaccessible occlusion.
- IV tPA + IA urokinase protocol : Combined intravenous tPA (0.6 mg/kg, 10% of the dose as a bolus and the remainder over 30 minutes) with intra-arterial urokinase will be administered to those within 3 hours from first found abnormal time who had catheter-accessible arterial occlusion.
- IA UK protocol : Intra-arterial urokinase will be given to those between 3 and 6 hours after first found abnormal time who had catheter-accessible arterial occlusion.
-
-
Outcome variables
- Safety outcomes Symptomatic intracranial hemorrhage (ICH) within 48 hours from thrombolytic therapy.
-
Efficacy outcomes
- Long-term clinical outcomes (modified Rankin Scale) at 3 months
- Secondary efficacy outcomes : Good vs. Poor outcomes according to mRS responder analysis, Early neurological improvement, Immediate and 5-day recanalization on MRA or CTA
Study Type : | Observational |
Actual Enrollment : | 83 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | REperfusion Therapy in Acute Ischemic STroke With Unclear Onset by MRI Evaluation |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |
Group/Cohort |
---|
Acute ischemic stroke patients with unclear onset |
- Good clinical outcome defined as modified Rankin Scale 0-2 [ Time Frame: 3 months after treatment ]
- Symptomatic intracranial hemorrhage [ Time Frame: 48 hours after treatment ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138059
Principal Investigator: | Dong-Wha Kang, MD, PhD | Asan Medical Center |
Responsible Party: | Dong-Wha Kang, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01138059 History of Changes |
Other Study ID Numbers: |
AMC-2004-217 |
First Posted: | June 7, 2010 Key Record Dates |
Last Update Posted: | June 7, 2010 |
Last Verified: | October 2006 |
Keywords provided by Asan Medical Center:
Acute ischemic stroke with unclear onset time |
Additional relevant MeSH terms:
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |