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

NCT01455935 | Unknown Phase 2 DMC

• 1 other identifier: NEU 3200411A
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  Modified Rankin Scale (mRS) 90 days post treatment

  90 days

Secondary Outcomes (7)

• National Institute of Health Stroke Scale (NIHSS)

  24 hour

• National Institute of Health Stroke Scale (NIHSS)

  3-29 day

• Modified Rankin Scale (mRS)

  30 post treatment

• Thrombolysis In Myocardial Infarction (TIMI) Flow

  Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure

• Thomboylsis in Cerebral Ischemia (TICI) flow

  Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure

Study Arms (3)

Medical Therapy

ACTIVE COMPARATOR

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

Drug: Anti-platelets and statin

Intravenous Thrombolysis

EXPERIMENTAL

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

Drug: alteplase

Intra-Arterial Therapy

EXPERIMENTAL

-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)

Procedure: intra arterial intervention

Interventions

Anti-platelets and statin DRUG

Medical Therapy

alteplase DRUG

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

Intravenous Thrombolysis

intra arterial intervention PROCEDURE

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)

Intra-Arterial Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
• Historical Modified Rankin Scale (mRS) of ≥2
• National Institute of Health Stroke Scale (NIHSS)\<8 at the time of treatment
• Positive pregnancy test in women at age of childbearing
• Intracranial or intraspinal surgery within 3 months
• Stroke or serious head injury within 3 months
• History of intracranial hemorrhage
• Uncontrolled hypertension at time of treatment (eg, \>185 mm Hg systolic or \>110 mm Hg diastolic)
• Seizure at the onset of stroke
• Active internal bleeding
• Intracranial neoplasm
• Arteriovenous malformation or aneurysm
• Clinical presentation suggesting post-MI pericarditis
• Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) \>1.7
• Internation normalized ratio (INR) \>1.7

Sponsors & Collaborators

• Jacobs Neurological Institute: lead
• University at Buffalo Neurosurgery: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Millard Fillmore Gates Circle Hospital

Buffalo, New York, 14209, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Elad I Levy, MD

  University at Buffalo Neurosurgery

  STUDY DIRECTOR

• Tareq Kass-Hout, MD

  Jacobs Neurological Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tareq Kass-Hout, MD

CONTACT

716-887-5548; kasshouttareq@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Vascular/Neurology Resident in charge of stroke

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 20, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

US (1)