Safety of Intravenous Thrombolytics in Stroke on Awakening

NCT ID: NCT01643902

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV tPA

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

Group Type: EXPERIMENTAL

tPA

Intervention Type: 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.

Interventions

tPA

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.

Intervention Type: DRUG

Other Intervention Names

Activase; Alteplase

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Victor C Urrutia, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor C Urrutia, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29787575 (View on PubMed)

Other Identifiers

ML28242

Identifier Type: -

Identifier Source: org_study_id