MedTrace Logo

A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke

NCT02072226 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2018-07-03

Study results available
· View outcomes & findings →

Summary

PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).

Conditions

Interventions

DRUG

Alteplase

Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).

DRUG

Alteplase Placebo

Single dose of alteplase placebo will be administered as IV injection.

DRUG

Aspirin

Single dose of aspirin will be administered at 325 mg orally.

DRUG

Aspirin Placebo

Single dose of aspirin placebo will be administered orally.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-03-22
Completion
2017-03-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02072226 on ClinicalTrials.gov