Trial · NCT01976936
Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2
NCT01976936, Phase 2, Completed, Columbia University; results first posted 2025-12-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2. Trials, record NCT01976936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2
- NCT number
- NCT01976936
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 162 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Stroke, Rhabdomyolysis, Jaundice
- Interventions
- Low Dose Lovastatin, Placebo, High Dose Lovastatin
- First posted
- 2013-11-06
- Last updated
- 2025-12-01
- Results first posted
- 2025-12-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Participants With an Increase in Liver Function Tests (LFTs) | 7 Days | 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 CK (Creatine Kinase) at any time point \> 10 X upper limit of normal, or clinical evidence of muscle pain or weakness not related to the stroke and associated with CK \> 5 X upper limit of normal. |
| Secondary | Mean Score on NIH Stroke Scale (NIHSS) | 90 days | The National Institutes of Health Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke and to measure neurological outcomes. The NIHSS is composed of 11 items, with a score range of 0-42. Higher scores indicate greater impairment caused by a stroke. |
| Secondary | Total Number of Participants With a Barthel Index Score > 95 | 90 days | The Barthel Index will be used to measure functional outcomes by counting the total number of individuals with a Barthel index score greater than or equal to 95. Numerical scores based on whether an individual requires physical assistance to perform the task or can complete it independently. An individual scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities, indicative of a better outcome. |
| Secondary | Total Number of Participants With a Modified Rankin Score of 0-1 | 90 days | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It will be used as a measure of handicap by looking at the total number of individuals with a score of 0-1. The scale runs from 0-6, running from perfect health without symptoms (score of 0) to death (score of 6). A score of 0 indicates a better outcome. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Participants With an Increase in Liver Function Tests (LFTs) | 7 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Score on NIH Stroke Scale (NIHSS) | 90 days | Only includes individuals who completed the NIHSS. | score on a scale | MEAN |
| SECONDARY | Total Number of Participants With a Barthel Index Score > 95 | 90 days | Only includes individuals who completed Barthel Index. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Number of Participants With a Modified Rankin Score of 0-1 | 90 days | Only analyzed from individuals with modified rankin scale data at Day 90. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Participants With an Increase in Liver Function Tests (LFTs) | Standard | 1 | Participants | ||
| Total Number of Participants With an Increase in Liver Function Tests (LFTs) | High Dose | 2 | Participants | ||
| Mean Score on NIH Stroke Scale (NIHSS) | Standard | 2.5 | Standard Deviation 3.3 | score on a scale | |
| Mean Score on NIH Stroke Scale (NIHSS) | High Dose | 3.3 | Standard Deviation 4.2 | score on a scale | |
| Total Number of Participants With a Barthel Index Score > 95 | Standard | 46 | Participants | ||
| Total Number of Participants With a Barthel Index Score > 95 | High Dose | 38 | Participants | ||
| Total Number of Participants With a Modified Rankin Score of 0-1 | Standard | 29 | Participants | ||
| Total Number of Participants With a Modified Rankin Score of 0-1 | High Dose | 31 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard | 81 | |
| Overall Study | STARTED | High Dose | 81 | |
| Overall Study | COMPLETED | Standard | 72 | |
| Overall Study | COMPLETED | High Dose | 77 | |
| Overall Study | NOT COMPLETED | Standard | 9 | |
| Overall Study | NOT COMPLETED | High Dose | 4 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infections and Infestations | Infections and infestations | All Subjects Treated | 3 | 162 | 3 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | All Subjects Treated | 2 | 162 | 2 |
| other | Cardiac disorders | Cardiac disorders | All Subjects Treated | 1 | 162 | 1 |
| other | Psychiatric disorders | Psychiatric disorders | All Subjects Treated | 1 | 162 | 1 |
| other | Nervous system disorders | Nervous system disorders | All Subjects Treated | 1 | 162 | 1 |
| other | Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | All Subjects Treated | 1 | 162 | 1 |
| other | Investigations | Investigations | All Subjects Treated | 1 | 162 | 1 |
| serious | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | All Subjects Treated | 8 | 162 | 9 |
| serious | Infections and Infestations | Infections and infestations | All Subjects Treated | 37 | 162 | 41 |
| serious | Cardiac disorders | Cardiac disorders | All Subjects Treated | 35 | 162 | 36 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Subjects Treated | 2 | 162 |
| Total, other adverse events | All Subjects Treated | 8 | 162 |
| Total, serious adverse events | All Subjects Treated | 62 | 162 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50NS049060 | New York Columbia Collaborative SPOTRIAS | MARSHALL, RANDOLPH S | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2004 to 2013 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard vs High Dose: Total Number of Participants With an Increase in Liver Function Tests (LFTs) | Trial comparisons |
| Standard vs High Dose: Total Number of Participants With a Barthel Index Score > 95 | Trial comparisons |
| Standard vs High Dose: Total Number of Participants With a Modified Rankin Score of 0-1 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01976936
GET https://conductscience.org/api/trials/v1/NCT01976936/events?page=2