Clinical trial NCT00163163: Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Official title: Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolaemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women defined as having Age =\< 70 years with documented menopause
* Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =\< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet
* Triglycerides =\< 4 g/l(4.52 mmol/l)
* Informed, written consent

Exclusion Criteria:

* Age \> 70 years
* Unconfirmed menopause
* Overall duration of treatment with any HMG-CoA Reductase inhibitor \> 3 months within the last year
* Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization
* History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA
* CPK levels \> 3 times upper limit of normal
* Body Mass Index \>= 30

Primary outcomes:
measure: Mean change in carotid IMT from baseline to month 12.
Secondary outcomes:
measure: Mean change from baseline to month 12 of carotid internal diameter (ID)
measure: wall cross sectional area (WCSA); carotid arterial mass (AM)
measure: pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)
measure: pulse wave velocity (PWV); Lipid profile
Other outcomes:
Locations:
city: Afsnee GENT
country: Belgium
facility: Pfizer Investigational Site
city: Assenede
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Ertvelde
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Linkebeek
country: Belgium
facility: Pfizer Investigational Site
city: Sint-niklaas
country: Belgium
facility: Pfizer Investigational Site
city: Tielt
country: Belgium
facility: Pfizer Investigational Site
city: Wetteren
country: Belgium
facility: Pfizer Investigational Site
city: Wondelgem
country: Belgium
facility: Pfizer Investigational Site
city: Achenheim
country: France
facility: Pfizer Investigational Site
city: Ancerville
country: France
facility: Pfizer Investigational Site
city: Augny
country: France
facility: Pfizer Investigational Site
city: Bar Le Duc
country: France
facility: Pfizer Investigational Site
city: Boersch
country: France
facility: Pfizer Investigational Site
city: Bois-Colombes
country: France
facility: Pfizer Investigational Site
city: Boissy Saint Leger
country: France
facility: Pfizer Investigational Site
city: Bouzonville
country: France
facility: Pfizer Investigational Site
city: Colombey-Les-Belles
country: France
facility: Pfizer Investigational Site
city: Dammarie Les Lys
country: France
facility: Pfizer Investigational Site
city: Docelles
country: France
facility: Pfizer Investigational Site
city: Dourdan
country: France
facility: Pfizer Investigational Site
city: Eckbolsheim
country: France
facility: Pfizer Investigational Site
city: Epinay S/orge
country: France
facility: Pfizer Investigational Site
city: Etampes
country: France
facility: Pfizer Investigational Site
city: Frouard
country: France
facility: Pfizer Investigational Site
city: Gambsheim
country: France
facility: Pfizer Investigational Site
city: Haguenau
country: France
facility: Pfizer Investigational Site
city: Kilstett
country: France
facility: Pfizer Investigational Site
city: Laxou
country: France
facility: Pfizer Investigational Site
city: le Grand Quevilly
country: France
facility: Pfizer Investigational Site
city: Le Mesnil Esnard
country: France
facility: Pfizer Investigational Site
city: Leuville Sur Orge
country: France
facility: Pfizer Investigational Site
city: Lingolsheim
country: France
facility: Pfizer Investigational Site
city: Longpont Sur Orge
country: France
facility: Pfizer Investigational Site
city: Mars LA Tour
country: France
facility: Pfizer Investigational Site
city: Metz
country: France
facility: Pfizer Investigational Site
city: Moutiers
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Pont a Mousson
country: France
facility: Pfizer Investigational Site
city: Pont-a-mousson
country: France
facility: Pfizer Investigational Site
city: Pulnoy
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: Sainte Genevieve Des Bois
country: France
facility: Pfizer Investigational Site
city: Sauvigny
country: France
facility: Pfizer Investigational Site
city: Savigny Sur Orge
country: France
facility: Pfizer Investigational Site
city: Sotteville Les Rouen Cedex
country: France
facility: Pfizer Investigational Site
city: Souffelweyersheim
country: France
facility: Pfizer Investigational Site
city: St Max
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Terville
country: France
facility: Pfizer Investigational Site
city: Toul
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre
country: France
facility: Pfizer Investigational Site
city: Verdun
country: France
facility: Pfizer Investigational Site
city: Vincennes
country: France
facility: Pfizer Investigational Site
city: ED Voerendaal
country: Netherlands
facility: Pfizer Investigational Site
city: EN Vaals
country: Netherlands
facility: Pfizer Investigational Site
city: VE Maastricht
country: Netherlands
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.