NCT01975194

Brief Summary

This study will assess the rate at which rosuvastatin will achieve LDL targets in African American patients with previous history of stroke or TIA.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4 stroke

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4 stroke

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

Study Start

First participant enrolled

January 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

October 28, 2013

Last Update Submit

November 1, 2013

Conditions

StrokeTransient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

  • LDL value

    LDL value recorded three months after study entry

    three months

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

Patients that receive rosuvastatin

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

Patients will be started at 20 mg per day and then increased to 40 mg per day if not at target by six weeks

Also known as: Crestor
Rosuvastatin

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30 and above
  • Rankin score of ≤ 3
  • Patient has a fixed telephone number and is available for follow-up
  • African American
  • Diagnosis of ischemic stroke or TIA in past 12 months

You may not qualify if:

  • Liver enzyme abnormalities (ALT or AST \>2x ULN)
  • Known muscle disorder or CK \> 5x ULN
  • Alcoholism or substance abuse
  • Stroke due to dissection or hypercoagulable state
  • Moderate to severe dementia (MMSE \<20)
  • On hemodialysis
  • No fixed home address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Seemant Chaturvedi, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 4, 2013

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

US(1)