- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01092819
A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial (FIRST)
April 10, 2019 updated by: Penumbra Inc.
Functional Outcome and Recovery After STROKE: The FIRST Trial
Current literature has only limited information on the natural history of acute ischemic stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from symptom onset, particularly on 90 day functional outcome as defined by the mRS.
Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, China
- Queen Mary Hospital
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Shatin, Hong Kong, China
- The Prince of Wales Hospital
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Texas
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Plano, Texas, United States, 75075
- Texas Stroke Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion and a known infarct volume will be enrolled and followed for 90-days.
Description
Inclusion Criteria:
- From 18 to 85 years of age.
- Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1)(TICI 0-1) from CT Angiography. Target vessel occlusion may include the anterior circulation.
- Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
- At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score greater than 10
- Known core infarct volume assessed by CTP, CTA or DWI scans
Exclusion Criteria:
- History of stroke in the past 3 months.
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 1
- Known severe allergy to contrast media
- Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure less than 110 mmHg)
CT evidence of the following conditions before enrollment:
- Significant mass effect with midline shift
- Evidence of intracranial hemorrhage
- Treated with endovascular therapy for acute stroke
- Life expectancy less than 90 days
- Participation in another clinical investigation that could confound the evaluation of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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acute ischemic stroke
Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion.
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The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain.
Patients with current standard of care other than IV rtPA or IA therapies will be studied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
Time Frame: 90 days after presentation
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90 days after presentation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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• Good neurological recovery as defined by a NIHSS score of 0-1 at discharge or a 10-point or more improvement in this scale at discharge.
Time Frame: Discharge and 90 days after presentation
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Discharge and 90 days after presentation
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All cause mortality
Time Frame: Dishcharge and 90 days after presentation
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Dishcharge and 90 days after presentation
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Incidence of symptomatic and asymptomatic hemorrhage
Time Frame: Dishcharge and 90 days after presentation
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Dishcharge and 90 days after presentation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
March 24, 2010
First Posted (Estimate)
March 25, 2010
Study Record Updates
Last Update Posted (Actual)
April 12, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLP 2988.B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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