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NCT01778855 · ClinicalTrials.gov registry record · Phase 2
Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization
A Phase 2 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01778855: Clinical Trial Phase 2 study, sponsored by University of California, Los Angeles.
NCT01778855 is a Phase 2 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01778855, a Phase 2 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to compare key imaging measurements for serial changes in recanalization and reperfusion between hypothermia and normothermia treatment arms as intermediate outcomes of treatment effect. Secondary exploratory analyses include imaging of the neurovascular impact of reperfusion with hypothermia and tPA, including blood-brain barrier changes or permeability, hemorrhagic transformation, and infarct growth.
Primary Outcome
To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition. Additional data for secondary analyse
Interventions
- OTHER IV t-PA and normothermia
- DEVICE IV-tPA and hypothermia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
Why NCT01778855 stopped before completion
NCT01778855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which IV t-PA and normothermia is the first listed.
NCT01778855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01778855 about?
NCT01778855 is a clinical study titled "Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization". The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to compare key imaging measurements for serial changes in recanalization and reperfusion between hypothermia and normothermia treatment arms as intermediate outcomes of treatment effect. Secondary exploratory a...
What is the current status of trial NCT01778855?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2013-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01778855?
The interventions under investigation include: IV t-PA and normothermia (OTHER), IV-tPA and hypothermia (DEVICE).
Who is sponsoring clinical trial NCT01778855?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01778855's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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