NCT00163150

Brief Summary

The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2003

Typical duration for phase_4

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

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

First QC Date

September 9, 2005

Last Update Submit

February 17, 2021

Conditions

Cerebrovascular AccidentHypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.

Secondary Outcomes (1)

  • Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on endothelium dependant and independent vasomotoricity of humeral and / or common carotid artery (according to validation study) in lacunar patients.

Interventions

AtorvastatinDRUG

Eligibility Criteria

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

You may qualify if:

  • small deep infarct on diffusion MRI (Diffusion Weighted Imaging)
  • no atherothrombotic, cardio-embolic, or other rarer cause.

You may not qualify if:

  • patients with past coronary event
  • contra-indication for assessment of vasomotor reactivity
  • patients being on statin therapy at the time of brain infarction
  • contra-indication for statin therapy
  • patient still under statin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Paris, 75877, France

Location

Related Publications (1)

  • Lavallee PC, Labreuche J, Gongora-Rivera F, Jaramillo A, Brenner D, Klein IF, Touboul PJ, Vicaut E, Amarenco P; Lacunar-BICHAT Investigators. Placebo-controlled trial of high-dose atorvastatin in patients with severe cerebral small vessel disease. Stroke. 2009 May;40(5):1721-8. doi: 10.1161/STROKEAHA.108.540088. Epub 2009 Mar 12.

    PMID: 19286582DERIVED

Related Links

MeSH Terms

Conditions

StrokeHypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

June 1, 2003

Study Completion

February 1, 2006

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

FR(1)