ClinicalTrials.gg
Status unknownNCT01770197Updated Dec 10, 2014

Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window

An observational study in Stroke, sponsored by Wuhan General Hospital of Guangzhou Military Command. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-10.

Sponsored by Wuhan General Hospital of Guangzhou Military Command · Observational

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Read the detailed description

Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

02

Conditions studied

  • Stroke

Browse trials for

Keywords

  • China
  • Stroke
  • Thrombolytic therapy
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 200 is above the median of 160 across 1,729 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Wuhan General Hospital of Guangzhou Military Command is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

stroke patients in the 3-4.5 hour time window

Eligibility criteria

Inclusion Criteria:stroke patients in the 3-4.5 hour time window -

Exclusion Criteria:stroke patients in more than 4.5 hour time window

-

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
24 Weeks
Patient registry
Yes

Groups and cohorts

  • recombinant tissue plasminogen activator

    Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.

    Drug: IV rt-PA

  • rt-PA

    One group of was treated with standard recombinant tissue plasminogen activator therapy in 3h and the other group of stroke patients was treated within 3-4.5h.

    Drug: IV rt-PA

Interventions

  • IV rt-PA treatment

    Also known as: rt-PA

06

What researchers measure

Primary outcomes

  1. National Institute of Health Stroke Scale score and modified Rankin Scale

    Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up

    Time frame: Outcome measure will be assessed at 24 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2013
First posted
Jan 17, 2013
Start
Jan 2008
Primary completionEst.
Dec 2014
CompletionEst.
Dec 2014
Last update
Dec 10, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01770197
Lead sponsor
Wuhan General Hospital of Guangzhou Military Command
Responsible party
zhipeng xu (Wuhan General Hospital of Guangzhou Military Command, Wuhan General Hospital of Guangzhou Military Command) — Principal investigator
First posted
Jan 17, 2013
Start date
Jan 2008
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Dec 10, 2014

Study contacts

Wuhan G H, High
study chair · Wuhan General Hospital of Guangzhou Command

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion