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NCT01976936 · ClinicalTrials.gov registry record · Phase 2
Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
NCT01976936: Completed Phase 2 study, sponsored by Columbia University.
NCT01976936 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 162 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976936, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
Study Summary
This trial will be a phase 2 randomized safety study in which ischemic stroke patients will be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this Phase 2 study will be musculoskeletal and hepatic toxicity, defined by clinical and laboratory criteria, with a 3-month follow-up period (± 1 week). Secondary outcomes will include neurological outcome (National Institute of Health (NIH) Stroke Scale), functional outcomes (Barthel Index), and handicap (modified Rankin scores). Effects on inflammatory markers and lipid levels will also be assessed.
Primary Outcome
The development of clinical or laboratory evidence of major hepatic toxicity within 7 days of treatment onset or the development of clinical or laboratory evidence of rhabdomyolysis within 7 days of treatment onset. The primary safety outcome will be defined as: Liver toxicity: LFT increase at any time point \> 3X upper limit of normal or development of jaundice, otherwise unexplained coagulopathy, or other clinical evidence of hepatitis or liver failure; or Muscle toxicity: An increase in C
Interventions
- OTHER Placebo
- DRUG Low Dose Lovastatin
- DRUG High Dose Lovastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2009-02 |
| Est. Completion | 2015-11-30 |
| Phase | Phase 2 |
What the finished NCT01976936 record still lists
NCT01976936 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01976936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01976936 about?
NCT01976936 is a clinical study titled "Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2". This trial will be a phase 2 randomized safety study in which ischemic stroke patients will be randomly assigned within 24 hours of symptom onset to placebo or standard dose lovastatin versus short-term high-dose lovastatin 640 mg per day for 3 days. The primary outcome of this Phase 2 study will be...
What is the current status of trial NCT01976936?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2009-02. Estimated completion is 2015-11-30.
What interventions are being tested in trial NCT01976936?
The interventions under investigation include: Placebo (OTHER), Low Dose Lovastatin (DRUG), High Dose Lovastatin (DRUG).
Who is sponsoring clinical trial NCT01976936?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976936's enrollment target sits among peer trials
162 418th of 2000 higher than 1,579 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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