A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01092819
First received: March 23, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Stroke
Other: Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcome and Recovery After STROKE: The FIRST Trial

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2. [ Time Frame: 90 days after presentation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Dishcharge and 90 days after presentation ] [ Designated as safety issue: No ]
  • Incidence of symptomatic and asymptomatic hemorrhage [ Time Frame: Dishcharge and 90 days after presentation ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092819

Contacts
Contact: Siu Po Sit, PhD 510 748 3200 ext 221 siupo.sit@penumbrainc.com
Contact: Leticia Barraza, BS 510 748 3200 ext 267 leticia.barraza@penumbrainc.com

Locations
United States, Texas
Texas Stroke Institute Recruiting
Plano, Texas, United States, 75075
Contact: Vallabh Janardhan, MD    646-270-3531    drvallabh@yahoo.com   
Principal Investigator: Vallabh Janardhan, MD         
China, Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: Raymond Cheung, MD       rtcheung@hkucc.hku.hk   
Principal Investigator: Raymond Cheung, MD         
The Prince of Wales Hospital Recruiting
Shatin, Hong Kong, China
Contact: Thomas W H Leung, MD         
Principal Investigator: Thomas W H Leung, MD         
Sponsors and Collaborators
Penumbra Inc.
Investigators
Study Director: Siu Po Sit, PhD Penumbra Inc.
  More Information

No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01092819     History of Changes
Other Study ID Numbers: CLP 2988.B
Study First Received: March 23, 2010
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Penumbra Inc.:
acute ischemic stroke, large vessel occlusion, natural history, functional outcome

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 26, 2014