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Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention

NCT01455935 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2012-03-30

No results posted yet for this study

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

Interventions

DRUG

Anti-platelets and statin

DRUG

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

PROCEDURE

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)

Sponsors & Collaborators

  • University at Buffalo Neurosurgery

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Jacobs Neurological Institute

    lead OTHER

Principal Investigators

  • Elad I Levy, MD · University at Buffalo Neurosurgery

  • Tareq Kass-Hout, MD · Jacobs Neurological Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-12-31
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455935 on ClinicalTrials.gov