At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 130 target
Drug / intervention
tissue plasminogen activator +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1 Study of Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
In Brief
A Phase 1 clinical trial evaluating hypothermia and tissue plasminogen activator for Stroke. Completed, enrolled 130 participants across 7 sites.
Detailed Summary
The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator (tPA) within 6 hours of stroke onset when combined with hypothermia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
First PostedJan 2006
Primary CompletionOct 2008
Study CompletionMay 2009
TodayJul 2026
First PostedJan 27, 2006
Enrollment StartOct 1, 2003
Primary CompletionOct 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.4 years ago
Interventions
hypothermiaprocedure
Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System. Subjects are stratified by time to six groups.
tissue plasminogen activatordrug
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots