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Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial of the Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke

NCT01098981 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2015-04-07

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

Conditions

  • Acute Ischemic Stroke

Interventions

DEVICE

Transcranial ultrasound as an adjunctive therapy to tPA

* tPA per approved labeling administered over 60 minutes * Ultrasonic headframe with active insonation for 120 minutes

DRUG

Standard of care tPA therapy for acute ischemic stroke

* tPA per approved labeling administered over 60 minutes * Ultrasonic headframe with sham (inactive) insonation for 120 minutes

Sponsors & Collaborators

  • Cerevast Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098981 on ClinicalTrials.gov