Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset

NCT ID: NCT01138059

Last Updated: 2010-06-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-06-30

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

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.

5. 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute ischemic stroke patients with unclear onset

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. The patient is male or female and age between 18 and 85 years

2. The patient has unclear onset stroke

3. Treatment of the patient can be initiated within 6 hours after first found abnormal time

4. The patient has imaging-defined penumbra (at least 20%), measured by diffusion- and perfusion-weighted MRI

Exclusion Criteria

1. The patient has minor neurologic deficits (NIHSS <4, except aphasia or hemianopia).

2. 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.

3. The patient has a pre-stroke mRS score of >1 (indicating previous disability).

4. The symptoms of stroke are suggestive of subarachnoid hemorrhage.

5. Evidence of infective endocarditis or septic embolism

6. The patient has a history or clinical presentation of ICH, SAH, or AVM.

7. Serious head trauma within 6 weeks

8. Prior ischemic stroke in previous 6 weeks (except small infarct)

9. Myocardial infarction in the previous 3 weeks

10. Gastrointestinal or urinary tract bleeding in previous 21 days

11. Major surgery in the previous 14 days

12. History of biopsy of a parenchymal organ, trauma with internal organ injury or lumbar puncture within 14 days

13. Arterial puncture at a non-compressible site in the previous 7 days

14. Uncontrolled high blood pressure (systolic > 185 mmHg or diastolic > 110 mmHg on 3 separate occasions at least 10 min apart despite appropriate treatment)

15. Evidence of active bleeding or acute trauma (fracture) on examination

16. Current use of oral anticoagulants and a prolonged prothrombin time (INR >1.7)

17. 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

18. Baseline platelet count < 100,000 mm3

19. Baseline hematocrit < 25%

20. Blood glucose concentration < 50 mg/dL (2.7 mmol/L) in case of CT screening

21. Seizure at onset with postictal residual neurological impairments in case of CT screening

22. The patient has a terminal illness.

23. The patient is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

24. 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

25. 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

26. 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Asan Medical Center

Principal Investigators

Dong-Wha Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Other Identifiers

AMC-2004-217

Identifier Type: -

Identifier Source: org_study_id