Recruiting
Phase 2

Intravenous Clot Busters & Endovascular Intervention

Sponsor:

Jacobs Neurological Institute

Code:

NCT01455935

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Anti-platelets and statin

alteplase

intra arterial intervention

Study Details

Brief summary:

The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.

Conditions

Stroke

Study ID

NCT01455935

Start date

Nov, 2011

Status verified date

Mar, 2012

Completion date

Feb, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation:

1. Age: 18-80 years old
2. Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)
3. National Institute of Health Stroke Scale (NIHSS) 8-22
4. Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above
5. Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)
6. Signed informed consent

Exclusion Criteria:

Exclusion Criteria: Potential study patients will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:

1. Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
2. Historical Modified Rankin Scale (mRS) of ≥2
3. National Institute of Health Stroke Scale (NIHSS)<8 at the time of treatment
4. Positive pregnancy test in women at age of childbearing
5. Intracranial or intraspinal surgery within 3 months
6. Stroke or serious head injury within 3 months
7. History of intracranial hemorrhage
8. Uncontrolled hypertension at time of treatment (eg, >185 mm Hg systolic or >110 mm Hg diastolic)
9. Seizure at the onset of stroke
10. Active internal bleeding
11. Intracranial neoplasm
12. Arteriovenous malformation or aneurysm
13. Clinical presentation suggesting post-MI pericarditis
14. Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) >1.7
15. Internation normalized ratio (INR) >1.7
16. Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation
17. Platelet count <100,000/mm
18. Major surgery within 2 weeks
19. GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks
20. Aggressive treatment required to lower blood pressure
21. Glucose level <50 or >400 mg/dL
22. Arterial puncture at a noncompressible site or lumbar puncture within 1 week

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Medical Therapy

Current standard of care per the latest stroke guidelines

  • Permissive Hypertension up to 220
  • Antipletelets therapy:

1. ASA 81 mg PO daily or
2. Plavix 75 mg PO daily or
3. Aggrenox 225mg PO twice daily
  • Anti-inflammatory therapy:

1. Lipitor 80 mg PO daily or
2. Crestor 20 mg PO daily

experimental: Intravenous Thrombolysis

Full dose Intravenous thrombolysis

  • 0.9 mg/kg
  • Maximum dose is 90 mg
  • 10% of the dose will be given over one minute
  • 90% of the dose will be infused over 1 hour
  • Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
  • Neuro checks every 5 minutes during the infusion
  • Neuro checks every hour after the infusion for 24 hours

experimental: Intra-Arterial Therapy

-Choice of therapy per experienced Endovascular surgeon and includes:

1. Intra arterial Activase (Maximum dose of 22 mg)
2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
3. PENUMBRA device (no standard time frame for how long the procedure takes)

Interventions

Anti-platelets and statin

alteplase

Full dose Intravenous thrombolysis

  • 0.9 mg/kg
  • Maximum dose is 90 mg
  • 10% of the dose will be given over one minute
  • 90% of the dose will be infused over 1 hour
  • Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
  • Neuro checks every 5 minutes during the infusion
  • Neuro checks every hour after the infusion for 24 hours

intra arterial intervention

1. Intra arterial Activase (Maximum dose of 22 mg)
2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
3. PENUMBRA device (no standard time frame for how long the procedure takes)

Primary outcome measure

  • Modified Rankin Scale (mRS) [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Tareq Kass-Hout, MD

716-887-5548kasshouttareq@gmail.com

Locations

Millard Fillmore Gates Circle Hospital

Recruiting

Buffalo, New York, United States, 14209

Contacts

Annemarie Crumlish

716-887-5548acrumlish@thejni.org

Principal Investigator:

Tareq Kass-Hout, MD

More Information

Sponsor

Jacobs Neurological Institute

Last update posted

Mar 30, 2012

Last verified

Mar, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jacobs Neurological Institute on 2012-03-30.