NCT00839449

Brief Summary

Cerebral vasospasm following subarachnoid hemorrhage (SAH) is the most common cause of morbidity and mortality. Recent studies indicate that Rho-kinase play an important role in the occurrence of such cerebral vasospasm. Eicosapentaenoic acid (EPA) inhibits sphingosylphosphorylcholine (SPC)-induced Rho-kinase activation in vitro. So this study examines whether EPA prevents cerebral vasospasm occurrence after SAH in patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

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, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

Enrollment Period

3.5 years

First QC Date

February 4, 2009

Last Update Submit

September 1, 2009

Conditions

Subarachnoid HemorrhageCerebral Vasospasm

Keywords

subarachnoid hemorrhagecerebral vasospasmeicosapentaenoic acid

Outcome Measures

Primary Outcomes (1)

  • Cerebral vasospasms: Symptomatic vasospasm defined as documented arterial vasospasm consistent with new neurological deterioration. New low-density areas on CT scans associated with vasospasm.

    Between 4 and 30 days after the onset of SAH

Secondary Outcomes (1)

  • Patient's Glasgow Outcome Scale (GOS).

    At 1 month after onset of SAH.

Study Arms (2)

A

EXPERIMENTAL

Patients in the group A are orally administered eicosapentaenoic acid ethyl ester.

Drug: Eicosapentaenoic acid ethyl ester

B

NO INTERVENTION

Patients in the group B (control) are not administered eicosapentaenoic acid ethyl ester.

Interventions

Eicosapentaenoic acid ethyl esterDRUG

Orally administered 900 mg eicosapentaenoic acid ethyl ester three times a day (2700 mg ⁄ day) from the surgery next day to 30 days after the onset of SAH.

Also known as: EPADEL S900 TM (EPA ethyl ester, purity >98%)
A

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subarachnoid hemorrhage (SAH)
  • The ruptured cerebral aneurysms conformed by cerebral angiography
  • The patients with treated by craniotomy and clip application within 72h after the onset of SAH

You may not qualify if:

  • Traumatic or mycotic aneurysms
  • A history or complication of serious stroke
  • Moya Moya disease
  • A history of SAH
  • Complication of serious heart or hepatic disease or infection or renal failure
  • Malignant tumor
  • Patients judged to be inappropriate by physician in charge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ootemachi Hospital

Kitakyushu, Fukuoka, 803-8543, Japan

Location

Nakamura Memorial Hospital

Sapporo, Hokkaido, 060-8570, Japan

Location

Iwate Medical University

Morioka, Iwate, 020-8505, Japan

Location

Tohoku University

Sendai, Miyagi, 980-8574, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

Related Publications (1)

  • Yoneda H, Shirao S, Nakagawara J, Ogasawara K, Tominaga T, Suzuki M. A prospective, multicenter, randomized study of the efficacy of eicosapentaenoic acid for cerebral vasospasm: the EVAS study. World Neurosurg. 2014 Feb;81(2):309-15. doi: 10.1016/j.wneu.2012.09.020. Epub 2012 Sep 29.

    PMID: 23032083DERIVED

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, Intracranial

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michiyasu Suzuki, MD, PhD

    Yamaguchi University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 9, 2009

Study Start

December 1, 2004

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations

JP(5)