Summary
Simvastatin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Stroke (Ischaemic / Cerebrovascular Disease) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Stroke (Ischaemic / Cerebrovascular Disease). ClinicalTrials.gov lists 8 registered trials linking Simvastatin to Stroke (Ischaemic / Cerebrovascular Disease): 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00079638). The largest enrolment is 25673 participants (NCT00461630). Registration activity spans 1998 to 2024. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 3 meta-analyses and 5 clinical trial publications. Publication years run from 2014 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Ischemic Stroke ranks 577 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous early neurological improvement in 10-20% within 24 hours of ischaemic stroke without intervention; functional independence at 3 months in only 40-50% without revascularisation; 15% 30-day mortality untreated.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01073007 | Stroke Treatment With Acute Reperfusion and Simvastatin 2009 | completed | Phase 4 | 104 |
| NCT00079638 | Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL 2004 | completed | Phase 4 | 300 |
| NCT00080275 | Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS) 2004 | completed | Phase 3 | 600 |
| NCT00461630 | Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE 2007 | completed | Phase 3 | 25,673 |
| NCT00124072 | Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine 1998 | completed | Phase 3 | 12,064 |
| NCT00120289 | Niacin Plus Statin to Prevent Vascular Events 2005 | terminated | Phase 3 | 3,414 |
| NCT00691314 | Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis 2008 | completed | Not applicable | 300 |
| NCT06785740 | Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study 2024 | recruiting | Not applicable | 300 |
Published literature
- Cochrane review High-dose statins for the prevention of recurrent ischemic stroke: a systematic review and meta-analysis of randomized controlled trialsShahid MS, Bourgleh MS, Alharfi A et al. · Annals of Saudi medicine · 2025 · PMID 40189852
- Clinical trial publication Effect of a Cardiovascular Polypill on Poststroke Cognition Among Ghanaians: Secondary Analysis of a Randomized Clinical TrialSarfo FS, Adu-Gyamfi R, Opare-Addo PA et al. · Journal of the American Heart Association · 2024 · PMID 39082406
- Clinical trial publication A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trialSarfo FS, Voeks J, Adamu S et al. · The Lancet. Global health · 2023 · PMID 37734804
- Cochrane review HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysisTunnicliffe DJ, Palmer SC, Cashmore BA et al. · The Cochrane database of systematic reviews · 2023 · PMID 38018702
- Meta-analysis Statin treatment and accrual of covert cerebral ischaemia on neuroimaging: a systematic review and meta-analysis of randomized trialsKatsanos AH, Lioutas VA, Charidimou A et al. · European journal of neurology · 2020 · PMID 32133735
- Meta-analysis Statin Therapy in Ischemic Stroke Models: A Meta-AnalysisChristophe B, Karatela M, Sanchez J et al. · Translational stroke research · 2020 · PMID 31788761
- Meta-analysis Comparison of statins for secondary prevention in patients with ischemic stroke or transient ischemic attack: a systematic review and network meta-analysisTramacere I, Boncoraglio GB, Banzi R et al. · BMC medicine · 2019 · PMID 30914063
- Clinical trial publication Prevention of Stroke with the Addition of Ezetimibe to Statin Therapy in Patients With Acute Coronary Syndrome in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)Bohula EA, Wiviott SD, Giugliano RP et al. · Circulation · 2017 · PMID 28972004
- Clinical trial publication Long-term Safety and Efficacy of Achieving Very Low Levels of Low-Density Lipoprotein Cholesterol : A Prespecified Analysis of the IMPROVE-IT TrialGiugliano RP, Wiviott SD, Blazing MA et al. · JAMA cardiology · 2017 · PMID 28291866
- Cochrane review Secondary prevention of major cerebrovascular events with seven different statins: a multi-treatment meta-analysisZhong P, Wu D, Ye X et al. · Drug design, development and therapy · 2017 · PMID 28919704
- Clinical trial publication Combination of Thrombolysis and Statins in Acute Stroke Is Safe: Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin)Montaner J, Bustamante A, García-Matas S et al. · Stroke · 2016 · PMID 27758944
- Cochrane review Lipid Screening in Childhood and Adolescence for Detection of Familial Hypercholesterolemia: Evidence Report and Systematic Review for the US Preventive Services Task ForceLozano P, Henrikson NB, Dunn J et al. · JAMA · 2016 · PMID 27532919
- Cochrane review Statins for acute coronary syndromeVale N, Nordmann AJ, Schwartz GG et al. · The Cochrane database of systematic reviews · 2014 · PMID 25178118
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Simvastatin approved for Stroke (Ischaemic / Cerebrovascular Disease)?
Simvastatin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Stroke (Ischaemic / Cerebrovascular Disease) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Stroke (Ischaemic / Cerebrovascular Disease). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Simvastatin in clinical trials for Stroke (Ischaemic / Cerebrovascular Disease)?
ClinicalTrials.gov lists 8 registered trials linking Simvastatin to Stroke (Ischaemic / Cerebrovascular Disease): 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00079638). The largest enrolment is 25673 participants (NCT00461630). Registration activity spans 1998 to 2024.
What does the evidence show for Simvastatin in Stroke (Ischaemic / Cerebrovascular Disease)?
Simvastatin has both completed registered trials and synthesis-level publications linked to Stroke (Ischaemic / Cerebrovascular Disease). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.