NCT00718328

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
8 years until next milestone

Results Posted

Study results publicly available

June 12, 2017

Completed
Last Updated

October 9, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

July 15, 2008

Results QC Date

May 7, 2017

Last Update Submit

September 8, 2017

Conditions

Intracerebral Hemorrhage

Keywords

IntracerebralHemorrhageEdemaStatins

Outcome Measures

Primary Outcomes (1)

  • Perihematomal Edema

    Solitary patient lost to follow up (out of state)

    Days 7 and 14

Study Arms (2)

I

EXPERIMENTAL

Simvastatin Group

Drug: Simvastatin 80 mg

II

PLACEBO COMPARATOR

Placebo Group

Drug: Placebo

Interventions

Simvastatin 80 mgDRUG

Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.

I
PlaceboDRUG

Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

II

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

  • 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.

    PMID: 17701108BACKGROUND

  • Naval 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.

    PMID: 17701107BACKGROUND

MeSH Terms

Conditions

Cerebral HemorrhageHemorrhageEdema

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Neeraj Naval
Organization
Johns Hopkins University SOM (former employer during the study)
neerajnaval@gmail.com
9042026290

Study Officials

  • Neeraj S Naval, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 18, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 9, 2017

Results First Posted

June 12, 2017

Record last verified: 2017-09

Locations

US(1)