NCT00235963

Brief Summary

To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

Enrollment Period

3.1 years

First QC Date

October 7, 2005

Last Update Submit

October 14, 2008

Conditions

Subarachnoid HemorrhageDelayed Vasospasm

Interventions

SimvastatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Aneurysmal subarachnoid hemorrhage, Fisher Grade III.
  • Patient or spouse or first degree relative able to give informed consent
  • Age greater then 18
  • Aneurysm secured surgically, or via endovascular technique
  • Subject seen within 96 hours of bleeding

You may not qualify if:

  • Contraindication for the use of simvastatin
  • Hunt-Hess Grade V
  • Initial intracranial pressure over 30 cm H2O and sustained for more then 30 minutes
  • Patient already on an HMG CoA-reductase inhibitor.
  • Patients with severe chronic renal failure (creatinine \>3 and/or BUN \>40).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Chou SH, Smith EE, Badjatia N, Nogueira RG, Sims JR 2nd, Ogilvy CS, Rordorf GA, Ayata C. A randomized, double-blind, placebo-controlled pilot study of simvastatin in aneurysmal subarachnoid hemorrhage. Stroke. 2008 Oct;39(10):2891-3. doi: 10.1161/STROKEAHA.107.505875. Epub 2008 Jul 24.

    PMID: 18658043DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Cenk Ayata, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

December 1, 2002

Primary Completion

January 1, 2006

Study Completion

February 1, 2006

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

US(1)