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

NCT01092819 | Completed

• 1 other identifier: CLP 2988.B
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief 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. Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials

Conditions

Stroke

Keywords

acute ischemic stroke, large vessel occlusion, natural history, functional outcome

Outcome Measures

Primary Outcomes (1)

• Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.

  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.

  Discharge and 90 days after presentation

• All cause mortality

  Dishcharge and 90 days after presentation

• Incidence of symptomatic and asymptomatic hemorrhage

  Dishcharge and 90 days after presentation

Study Arms (1)

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

Interventions

Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies OTHER

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.

acute ischemic stroke

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (3)

Texas Stroke Institute

Plano, Texas, 75075, United States

Location

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

The Prince of Wales Hospital

Shatin, Hong Kong, China

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Siu Po Sit, PhD

  Penumbra Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

US (1); CN (2)