A Phase 2 interventional study of Low Dose Lovastatin and Placebo in Stroke, Rhabdomyolysis and Jaundice, sponsored by Columbia University. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Columbia University · Phase 2, Interventional, and Treatment
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.
This is a phase 2 randomized, blinded and controlled safety study in patients with ischemic stroke. The time window for enrollment will be within 0-24 hours of symptom onset. For patients who are found with the stroke on awakening, it will be assumed that the stroke occurred the last time that the patient was known to be normal. All patients will be identified by the stroke acute care team in the emergency room of the participating centers, or in some cases, on the floor services of the hospital (i.e., for patients with stroke occurring in hospital). If preliminary data indicate that the patient meets eligibility criteria the patient (or legally authorized representative) will be approached about participation in the study, and consent obtained. Surrogate consent will be allowed at centers at which this is permitted according to regulations. Patients who are consented through a surrogate and subsequently regain capacity, will be approached and reconsented to continue in the study.
The intervention chosen for this trial is either (1) placebo for patients not taking a statin at the time of admission OR lovastatin 80 mg in place of their regular statin for patients taking a statin (atorvastatin, simvastatin, rosuvastatin, pravastatin, fluvastatin, lovastatin) at time of enrolment VERSUS (2) oral lovastatin at dosage of 640 mg daily for 3 days. The time of first dose will be considered time 0. Patients will be administered the total daily dose in four daily divided doses (i.e., QID schedule). After the initial 3 days of acute dosage, all patients will receive statin therapy at the discretion of their treating physician.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 162 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High dose lovastatin (640 mg daily for three days) will be administered orally
Drug: High Dose Lovastatin
Lovastatin 80 mg daily for three days will be administered orally to patients who were taking statin therapy at the time of enrolment
Drug: Low Dose Lovastatin
Placebo will be administered orally to patients who were NOT taking statin therapy at the time of enrolment
Other: Placebo
80 mg daily for 3 days
Also known as: Mevacor
Placebo for 3 days
Also known as: microcrystalline cellulose
640 mg daily for 3 days
Also known as: Mevacor
Total Number of Participants With an Increase in Liver Function Tests (LFTs)
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.
Time frame: 7 Days
Mean Score on NIH Stroke Scale (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.
Time frame: 90 days
Total Number of Participants With a Barthel Index Score > 95
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.
Time frame: 90 days
Total Number of Participants With a Modified Rankin Score of 0-1
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.
Time frame: 90 days
| Milestone | Standard | High Dose |
|---|---|---|
| Started | 81 | 81 |
| Completed | 72 | 77 |
| Not completed | 9 | 4 |
| Withdrew: Did not receive at least 9 doses | 9 | 4 |
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.
| Participants | Standard | High Dose |
|---|---|---|
| Total Number of Participants With an Increase in Liver Function Tests (LFTs) | 1 | 2 |
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.
| score on a scale | Standard | High Dose |
|---|---|---|
| Mean Score on NIH Stroke Scale (NIHSS) | 2.5 ± 3.3 | 3.3 ± 4.2 |
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.
| Participants | Standard | High Dose |
|---|---|---|
| Total Number of Participants With a Barthel Index Score > 95 | 46 | 38 |
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.
| Participants | Standard | High Dose |
|---|---|---|
| Total Number of Participants With a Modified Rankin Score of 0-1 | 29 | 31 |
Collected over Data was collected up to 1 year after data collection for all outcome measures.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects Treated | 2/162 (1.2%) | 62/162 (38.3%) | 8/162 (4.9%) |
| Event | All Subjects Treated |
|---|---|
| Nervous system disorderNervous system disorders | 48/162 |
| Infections and InfestationsInfections and infestations | 37/162 |
| Cardiac disordersCardiac disorders | 35/162 |
| InvestigationsInvestigations | 30/162 |
| Gastrointestinal disordersGastrointestinal disorders | 22/162 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 16/162 |
| Surgical and medical proceduresSurgical and medical procedures | 15/162 |
| Vascular disordersVascular disorders | 13/162 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 10/162 |
| Psychiatric disordersPsychiatric disorders | 9/162 |
| Event | All Subjects Treated |
|---|---|
| Infections and InfestationsInfections and infestations | 3/162 |
| Gastrointestinal disordersGastrointestinal disorders | 2/162 |
| Cardiac disordersCardiac disorders | 1/162 |
| Psychiatric disordersPsychiatric disorders | 1/162 |
| Nervous system disordersNervous system disorders | 1/162 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 1/162 |
| InvestigationsInvestigations | 1/162 |
Includes all individuals who received treatment.
| Age, Customized(Participants) | Standard | High Dose | Total |
|---|---|---|---|
| ≥ 18 years | 81 | 81 | 162 |
| Sex: Female, Male(Participants) | Standard | High Dose | Total |
|---|---|---|---|
| Female | 39 | 36 | 75 |
| Male | 42 | 45 | 87 |
Plan to share: Undecided
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Studies of the drug tested here: Lovastatin