Trial Outcomes & Findings for Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2 (NCT NCT01976936)
NCT ID: NCT01976936
Last Updated: 2025-12-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
7 Days
Results posted on
2025-12-01
Participant Flow
Participant milestones
| Measure |
Standard
Includes individuals on placebo or 80mg of Lovastatin
|
High Dose
Includes individuals on 640mg of Lovastatin
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
|
Overall Study
COMPLETED
|
72
|
77
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Standard
Includes individuals on placebo or 80mg of Lovastatin
|
High Dose
Includes individuals on 640mg of Lovastatin
|
|---|---|---|
|
Overall Study
Did not receive at least 9 doses
|
9
|
4
|
Baseline Characteristics
Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2
Baseline characteristics by cohort
| Measure |
Standard
n=81 Participants
Includes individuals on placebo or 80mg of Lovastatin
|
High Dose
n=81 Participants
Includes individuals on 640mg of Lovastatin
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≥ 18 years
|
81 Participants
n=121 Participants
|
81 Participants
n=122 Participants
|
162 Participants
n=243 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=121 Participants
|
36 Participants
n=122 Participants
|
75 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=121 Participants
|
45 Participants
n=122 Participants
|
87 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: 7 DaysThe 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.
Outcome measures
| Measure |
High Dose
n=81 Participants
Includes individuals on 640mg of Lovastatin
|
Standard
n=81 Participants
Includes individuals on placebo or 80mg of Lovastatin
|
|---|---|---|
|
Total Number of Participants With an Increase in Liver Function Tests (LFTs)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Only includes individuals who completed the NIHSS.
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.
Outcome measures
| Measure |
High Dose
n=62 Participants
Includes individuals on 640mg of Lovastatin
|
Standard
n=57 Participants
Includes individuals on placebo or 80mg of Lovastatin
|
|---|---|---|
|
Mean Score on NIH Stroke Scale (NIHSS)
|
3.3 score on a scale
Standard Deviation 4.2
|
2.5 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Only includes individuals who completed Barthel Index.
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.
Outcome measures
| Measure |
High Dose
n=70 Participants
Includes individuals on 640mg of Lovastatin
|
Standard
n=65 Participants
Includes individuals on placebo or 80mg of Lovastatin
|
|---|---|---|
|
Total Number of Participants With a Barthel Index Score > 95
|
38 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Only analyzed from individuals with modified rankin scale data at Day 90.
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.
Outcome measures
| Measure |
High Dose
n=72 Participants
Includes individuals on 640mg of Lovastatin
|
Standard
n=67 Participants
Includes individuals on placebo or 80mg of Lovastatin
|
|---|---|---|
|
Total Number of Participants With a Modified Rankin Score of 0-1
|
31 Participants
|
29 Participants
|
Adverse Events
All Subjects Treated
Serious events: 62 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
All Subjects Treated
n=162 participants at risk
This includes all individuals who began treatment with the study medication.
|
|---|---|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
4.9%
8/162 • Number of events 9 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Infections and infestations
Infections and Infestations
|
22.8%
37/162 • Number of events 41 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Cardiac disorders
Cardiac disorders
|
21.6%
35/162 • Number of events 36 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Nervous system disorders
Nervous system disorder
|
29.6%
48/162 • Number of events 54 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
6.2%
10/162 • Number of events 11 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
4.9%
8/162 • Number of events 9 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.9%
3/162 • Number of events 3 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.62%
1/162 • Number of events 1 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
1.9%
3/162 • Number of events 3 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
13.6%
22/162 • Number of events 26 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
9.3%
15/162 • Number of events 17 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Vascular disorders
Vascular disorders
|
8.0%
13/162 • Number of events 15 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Investigations
Investigations
|
18.5%
30/162 • Number of events 40 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Psychiatric disorders
Psychiatric disorders
|
5.6%
9/162 • Number of events 9 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
3.1%
5/162 • Number of events 6 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
1.2%
2/162 • Number of events 2 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
9.9%
16/162 • Number of events 19 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
3.7%
6/162 • Number of events 6 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Immune system disorders
Immune system disorders
|
1.2%
2/162 • Number of events 2 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Eye disorders
Eye disorders
|
0.62%
1/162 • Number of events 1 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
General disorders
General disorders and administration site conditions
|
2.5%
4/162 • Number of events 4 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
Other adverse events
| Measure |
All Subjects Treated
n=162 participants at risk
This includes all individuals who began treatment with the study medication.
|
|---|---|
|
Infections and infestations
Infections and Infestations
|
1.9%
3/162 • Number of events 3 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
1.2%
2/162 • Number of events 2 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Cardiac disorders
Cardiac disorders
|
0.62%
1/162 • Number of events 1 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.62%
1/162 • Number of events 1 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Nervous system disorders
Nervous system disorders
|
0.62%
1/162 • Number of events 1 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.62%
1/162 • Number of events 1 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
|
Investigations
Investigations
|
0.62%
1/162 • Number of events 1 • Data was collected up to 1 year after data collection for all outcome measures.
Data regarding all non-serious and serious adverse events were collected according to the system type per kit used by subjects, so safety data is reported as a combined summary (incorporates all arms) and not reported per arm. The adverse event data is only available as a summary (arms combined) and cannot be separated by arm as the study has closed with the Institutional Review Board (IRB) and additional analysis cannot be performed.
|
Additional Information
Mitchell S.V. Elkind, MD, MS, MPhil
Columbia University
Phone: 212-305-1710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place