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Completed

NCT Number: NCT01092819

A Clinical Trial to Assess the Acute Safety and 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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Queen Mary Hospital, Hong Kong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 90 days after presentation

Secondary outcomes

  1. • 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

  2. All cause mortality

    Time frame: Dishcharge and 90 days after presentation

  3. Incidence of symptomatic and asymptomatic hemorrhage

    Time frame: Dishcharge and 90 days after presentation

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

Functional Outcome and Recovery After STROKE: The FIRST Trial

Acronym: FIRST

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2010
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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