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

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:

Drug Information available for: Alteplase

U.S. FDA Resources

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:	March 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (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

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:	December 10, 2012
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 May 23, 2013