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

Stroke Clinical Trial

— FIRST  

Official title:

Functional Outcome and Recovery After STROKE: The FIRST Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092819
• Other study ID #: CLP 2988.B
• Status: Completed
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2019
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong	Hong Kong
China	The Prince of Wales Hospital	Shatin	Hong Kong
United States	Texas Stroke Institute	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.		90 days after presentation
Secondary	• 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
Secondary	All cause mortality		Dishcharge and 90 days after presentation
Secondary	Incidence of symptomatic and asymptomatic hemorrhage		Dishcharge and 90 days after presentation