StrokeFIRSTNCT01092819
A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial
An observational study of Stroke, run by Penumbra Inc. at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Stroke
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Queen Mary Hospital
Hong Kong, Hong Kong
The Prince of Wales Hospital
Shatin, Hong Kong
About this study
Official title: 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
- Conditions
- Stroke
- Being tested
- Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies
- Keywords
- acute ischemic stroke, large vessel occlusion, natural history, functional outcome
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
Measured: 90 days after presentation
Secondary outcomes (3)
• 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.
Measured: Discharge and 90 days after presentation
All cause mortality
Measured: Dishcharge and 90 days after presentation
Incidence of symptomatic and asymptomatic hemorrhage
Measured: Dishcharge and 90 days after presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siu Po Sit, PhD, Study director, Penumbra Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092819
- Sponsor's protocol ID
- CLP 2988.B
- Acronym
- FIRST
- Status last verified
- Apr 2019
- First submitted
- 23 Mar 2010
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome and Recovery After STROKE: The FIRST Trial
- ClinicalTrials.gov ID
- NCT01092819
- Acronym / sponsor ID
- FIRST / CLP 2988.B
- Conditions
- Stroke
- Keywords
- acute ischemic stroke, large vessel occlusion, natural history, functional outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute ischemic stroke | – | Other: Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapiesPatients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapiesThe 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. | Other | acute ischemic stroke |
Primary outcome
Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
Time frame: 90 days after presentation
3 secondary outcomes
• 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
All cause mortality
Time frame: Dishcharge and 90 days after presentation
Incidence of symptomatic and asymptomatic hemorrhage
Time frame: Dishcharge and 90 days after presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siu Po Sit, PhD study director
Penumbra Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Penumbra Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2. (time frame: 90 days after presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.