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NCT01643902 · ClinicalTrials.gov registry record · Phase 2

Safety of Intravenous Thrombolytics in Stroke on Awakening

A Phase 2 study of Stroke, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT01643902: Completed Phase 2 study of Stroke, sponsored by Johns Hopkins University.

NCT01643902 is a Phase 2 study of Stroke that has completed, run by Johns Hopkins University. The registered enrollment target is 20 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01643902, a Phase 2 study of Stroke, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute stroke. The hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ED within that time, therefore IV tPA should be safe and effective in this population.

Primary Outcome

Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison. ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline. NINDS IV tPA trial criteria: a hemorrhage not seen in previous

Conditions Studied

Interventions

  • DRUG tPA

Study Locations (2)

Maryland

  • Johns Hopkins Bayview Medical Center - Baltimore
  • The Johns Hopkins Hospital - Baltimore

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2013-01
Est. Completion 2015-12
Phase Phase 2
Johns Hopkins University

1,448 total trials

What the finished NCT01643902 record still lists

NCT01643902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).

The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 1 intervention - of which tPA is the first listed.

NCT01643902 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT01643902 about?

NCT01643902 is a clinical study titled "Safety of Intravenous Thrombolytics in Stroke on Awakening". The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV ...

What is the current status of trial NCT01643902?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-01. Estimated completion is 2015-12.

What conditions does trial NCT01643902 study?

This clinical trial studies the following conditions: Stroke.

What interventions are being tested in trial NCT01643902?

The interventions under investigation include: tPA (DRUG).

Who is sponsoring clinical trial NCT01643902?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01643902 being conducted?

This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01643902's enrollment target sits among peer trials

20 361st of 454 higher than 74 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01643902, the US trial registry maintained by the National Library of Medicine. NCT01643902 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.