Intracerebral HemorrhagePhase 2NCT00718328
Simvastatin For Intracerebral Hemorrhage Study
A Phase 2 study testing Simvastatin 80 mg in people with Intracerebral Hemorrhage, run by Johns Hopkins University at 1 site in United States.
Trial summary
Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Simvastatin 80 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.
Who cannot join
- Age < 18 or > 85
- Admission Glasgow Coma Score (GCS) < 6
- ICH volume < 10 cc
- ICH secondary to trauma, aneurysm, Arterio-Venous Malformation (AVM), tumor or post surgical
- Multiple ICH
- Associated Subdural hematoma or significant Subarachnoid hemorrhage
Show all 14Show fewer
- History of prior neurologic disease with modified Rankin Scale (mRS) > 1
- Hematoma evacuation, hemicraniectomy, clot lysis
- Myopathy
- Active Liver disease
- Pregnancy
- Statin allergy
- Patients on statins prior to admission
- Patients with an acute indication for statin therapy (Unstable angina)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH).
Read the detailed description
Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. The reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ICH seems to play an important role.
The Simvastatin for Intracerebral Hemorrhage Study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group.
The hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following Intracerebral Hemorrhage (ICH). This hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ICH, and on a retrospective review of patients admitted to The Johns Hopkins Hospital over the last 7 years with spontaneous ICH which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Simvastatin 80 mg, Placebo
- Keywords
- Intracerebral, Hemorrhage, Edema, Statins
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhage, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 80 mgDrug
Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
PlaceboDrug
Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Simvastatin Group Receives: Drug: Simvastatin 80 mg |
| II | Placebo comparator | Placebo Group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perihematomal Edema
Solitary patient lost to follow up (out of state)
Measured: Days 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Poor recruitment, trial terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Neeraj S Naval, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718328
- Sponsor's protocol ID
- NA_00016284
- Other IDs
- NIH UL1 RR 025005
- Status last verified
- Sep 2017
- First submitted
- 15 Jul 2008
- Last updated
- 9 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Naval NS, Abdelhak TA, Zeballos P, Urrunaga N, Mirski MA, Carhuapoma JR. Prior statin use reduces mortality in intracerebral hemorrhage. Neurocrit Care. 2008;8(1):6-12. doi: 10.1007/s12028-007-0080-2.
PubMed 17701108Naval NS, Abdelhak TA, Urrunaga N, Zeballos P, Mirski MA, Carhuapoma JR. An association of prior statin use with decreased perihematomal edema. Neurocrit Care. 2008;8(1):13-8. doi: 10.1007/s12028-007-0081-1.
PubMed 17701107
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin For Intracerebral Hemorrhage Study
- ClinicalTrials.gov ID
- NCT00718328
- Acronym / sponsor ID
- NA_00016284
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral, Hemorrhage, Edema, Statins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment, trial terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Institutes of Health (NIH)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 12 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH).
Detailed description
Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. The reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ICH seems to play an important role.
The Simvastatin for Intracerebral Hemorrhage Study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group.
The hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following Intracerebral Hemorrhage (ICH). This hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ICH, and on a retrospective review of patients admitted to The Johns Hopkins Hospital over the last 7 years with spontaneous ICH which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Simvastatin 80 mgSimvastatin Group |
| II | Placebo comparator | Drug: PlaceboPlacebo Group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.
Key exclusion criteria (14 listed)
- Age < 18 or > 85
- Admission Glasgow Coma Score (GCS) < 6
- ICH volume < 10 cc
- ICH secondary to trauma, aneurysm, Arterio-Venous Malformation (AVM), tumor or post surgical
- Multiple ICH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 80 mgPatients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge. | Drug | I |
| PlaceboPatients in study arm II will receive placebo once daily for 14 days or until death or discharge. | Drug | II |
Primary outcome
Perihematomal Edema
Time frame: Days 7 and 14
Solitary patient lost to follow up (out of state)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17701108Naval NS, Abdelhak TA, Zeballos P, Urrunaga N, Mirski MA, Carhuapoma JR. Prior statin use reduces mortality in intracerebral hemorrhage. Neurocrit Care. 2008;8(1):6-12. doi: 10.1007/s12028-007-0080-2.
- Background: PubMed 17701107Naval NS, Abdelhak TA, Urrunaga N, Zeballos P, Mirski MA, Carhuapoma JR. An association of prior statin use with decreased perihematomal edema. Neurocrit Care. 2008;8(1):13-8. doi: 10.1007/s12028-007-0081-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neeraj S Naval, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin 80 mg in people with Intracerebral Hemorrhage, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perihematomal Edema (time frame: Days 7 and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00718328, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017; AzTrials last refreshed its copy on 26 Oct 2026.