Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke

NCT01869478 | Terminated Phase 2 Results

• 1 other identifier: 12-002496
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-PA) in a time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A randomized trial is justified for the following reasons: 1) The high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in North America without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.

Conditions

Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Recanalization Rate of Primary Intracranial Occlusion

  The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).

  24 hours

Secondary Outcomes (1)

• Mean Score on Modified Rankin Scale at 90 Days

  90 days

Study Arms (2)

Intravenous Thrombolysis

ACTIVE COMPARATOR

0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.

Drug: Intravenous Thrombolysis

Endovascular Arterial Reperfusion

ACTIVE COMPARATOR

Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.

Device: Endovascular Arterial Reperfusion

Interventions

Intravenous Thrombolysis DRUG

Also known as: Altelplase, rtPA

Intravenous Thrombolysis

Endovascular Arterial Reperfusion DEVICE

Also known as: Penumbra, Solitaire

Endovascular Arterial Reperfusion

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Definite or probable ischemic stroke
• CT angiographic (CTA) evidence of intracranial vascular occlusion (internal carotid, middle cerebral - M1 or M2 divisions, anterior cerebral, posterior cerebral, or basilar artery) within 3.5 hours of symptom onset
• Able to receive assigned treatment within 4.5 hours of symptom onset
• Written informed consent from patient or surrogate, if unable to provide consent

You may not qualify if:

• CT evidence of early infarction in \>1/3 of middle cerebral artery distribution
• Blood pressure \> 185/110 mmHg refractory to anti-hypertensive therapy
• History of intracranial hemorrhage
• History of ischemic stroke within past 3 months
• History of major surgical procedure within past 14 days
• Gastrointestinal or genitourinary bleeding within past 14 days
• Glucose \<50 or \>400mg/dL
• Platelet count \<100,000
• International normalized ratio (INR) ≥ 1.7
• Known history of bleeding diathesis

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

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

Limitations and Caveats

This study was terminated due to difficulty in recruiting subjects.

Results Point of Contact

• Title: Kevin M. Barrett, MD
• Organization: Mayo Clinic

Barrett.Kevin@mayo.edu

904-953-9740

Study Officials

• Kevin M Barrett, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 1, 2013
• First Posted: June 5, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 5, 2016
• Results First Posted: October 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)