Safety of Intravenous Thrombolytics in Stroke on Awakening

NCT01643902 | Completed Phase 2 Results DMC

• 1 other identifier: ML28242
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute stroke. The hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ED within that time, therefore IV tPA should be safe and effective in this population.

Conditions

Stroke

Keywords

Stroke; Wake up; IV tPA; Thrombolytic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment

  Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison. ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline. NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage.

  within 36 hours of treatment

Secondary Outcomes (1)

• Functional Outcome by the Modified Rankin Scale at 90 Days

  90 days

Study Arms (1)

IV tPA

EXPERIMENTAL

Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria

Drug: tPA

Interventions

tPA DRUG

IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.

Also known as: Activase, Alteplase

IV tPA

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 greater or equal to 18 years, and lower or equal to 80 years.
• Signs and symptoms of acute ischemic stroke.
• Symptoms present upon awakening.
• Arriving to the Emergency Department within 4.5 hours of awakening. Treatment with IV tPA must be initiated prior to 4.5hours from waking up.
• NIHSS \>3
• A non-contrast head CT without hemorrhage and without hypodensity more than 1/3 of the middle cerebral artery (MCA) territory; or MRI demonstrating no hemorrhage, and with a diffusion-weighted imaging (DWI) lesion no greater than 70 mL and FLAIR without a well defined hyperintense lesion that is more than 1/3 of the MCA territory.
• Pre-morbid modified Rankin score of 0 or 1.

You may not qualify if:

• Rapidly improving deficit to an NIHSS less than 3.
• Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than 110 mmHg despite treatment.
• Glucose less than 50 mg/dL.
• Stroke or head trauma within last 3 months.
• History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
• Major surgery within 14 days.
• Gastrointestinal (GI)/Genito-urinary (GU) hemorrhage within 21 days.
• International normalized ratio (INR) \> 1.7.
• Heparin within 48 hours with an elevated activated partial thromboplastin time (aPTT).
• Platelet count less than 100,000.
• Presumed septic embolus or suspicion of bacterial endocarditis.
• Suspicion of aortic dissection.
• Use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin.
• Pregnant or lactating women.
• Known allergy or sensitivity to tPA.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Urrutia VC, Faigle R, Zeiler SR, Marsh EB, Bahouth M, Cerdan Trevino M, Dearborn J, Leigh R, Rice S, Lane K, Saheed M, Hill P, Llinas RH. Safety of intravenous alteplase within 4.5 hours for patients awakening with stroke symptoms. PLoS One. 2018 May 22;13(5):e0197714. doi: 10.1371/journal.pone.0197714. eCollection 2018.

  PMID: 29787575 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Victor C. Urrutia
• Organization: Johns Hopkins University School of Medicine

vurruti1@jhmi.edu

410-955-2228

Study Officials

• Victor C Urrutia, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-03

Locations

US (2)