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StrokeRESTORENCT01138059

Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset

An observational study of Stroke, run by Asan Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 is that the efficacy outcomes in UnCLOS group would be superior to those in historical UnCLOS group from prospective… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
How many people
83 participants
Where
No sites listed yet
Study dates
Oct 2006to Jun 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients with acute ischemic stroke visiting the ER within 6 hours of the detection of stroke symptoms will be screened for this study.

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 27Show fewer
  • 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).

About this study

Official title: REperfusion Therapy in Acute Ischemic STroke With Unclear Onset by MRI Evaluation

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 is that the efficacy outcomes in UnCLOS group would be superior to those in historical UnCLOS group from prospective stroke registries.

Read the 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 emergency room within 6 hours of the detection of stroke symptoms
  4. Methods
  • 3 thrombolysis protocols applicable to UnCLOS patients
  1. 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.
  2. 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.
  3. 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.
  4. Outcome variables
  • Safety outcomes Symptomatic intracranial hemorrhage (ICH) within 48 hours from thrombolytic therapy.
  • Efficacy outcomes
  1. Long-term clinical outcomes (modified Rankin Scale) at 3 months
  2. Secondary efficacy outcomes : Good vs. Poor outcomes according to mRS responder analysis, Early neurological improvement, Immediate and 5-day recanalization on MRA or CTA
Conditions
Stroke
Keywords
Acute ischemic stroke with unclear onset time
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01138059
Study groupRoleWhat they receive
Acute ischemic stroke patients with unclear onsetNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Good clinical outcome defined as modified Rankin Scale 0-2

    Measured: 3 months after treatment

  2. Symptomatic intracranial hemorrhage

    Measured: 48 hours after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2010 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01138059
Sponsor's protocol ID
AMC-2004-217
Acronym
RESTORE
Status last verified
Oct 2006
First submitted
4 Jun 2010
Last updated
7 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Asan Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Good clinical outcome defined as modified Rankin Scale 0-2 (time frame: 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01138059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2010.

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