Trials Sponsors Conditions Drugs Pricing

Conditions

Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm

Keywords

SAHVasospasm

Outcome Measures

Primary Outcomes (1)

To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH
21 days

Secondary Outcomes (1)

To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up
6 months

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Study Group #1

EXPERIMENTAL

Simvastatin 40 mg

Drug: Simvastatin 40 mg

Study Group #2

EXPERIMENTAL

Simvastatin 80 mg

Drug: Simvastatin 80 mg

Interventions

Simvastatin 40 mgDrug

Comparing two doses of Simvastatin to placebo

Also known as: Zocor

Study Group #1

PlaceboDrug

Placebo tablet

Also known as: dummy pill, sugar pill

Control Group

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years old inclusive
Subarachnoid hemorrhage diagnosed by CT on admission

Sponsors & Collaborators

University of Illinois at Chicago
Otherlead

Study Sites (1)

Univeristy of Illinois at Chicago, Dept of Neurosurgery

Chicago, Illinois, 60612, United States

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, Intracranial

Interventions

SimvastatinSugars

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed and Primary Physician leaving institution before study completion.

Results Point of Contact

Title: Ali Alaraj, MD
Organization: University of Illinois at Chicago

Study Officials

Ben Z. Roitberg, MD
Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery
PRINCIPAL INVESTIGATOR
Ali Alaraj, MD
Clinical Fellow Department of Neurosurgery
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 18, 2007

Study Start

May 2007

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Control Group

Study Group #1

Study Group #2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations