Clinical trial NCT00442325: Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
Official title: ACTFAST (2): Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration: A Multicenter, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving Low Density Lipoprotein Cholesterol (LDL-C) Target With Atorvastatin Starting Doses Of 10 mg, 20 mg, 40 mg, And 80 mg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Arteriosclerosis
Diabetes Mellitus, Type 2
Cerebrovascular Accident
Dyslipidemia
Peripheral Vascular Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)


Eligibility criteria: Inclusion Criteria:

* High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
* Triglycerides up to 600 mg/dL.
* History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events.

Exclusion Criteria:

* Pregnancy or lactation, use of high statin doses (\>40mg) at baseline, liver or renal problems
* Use of other drugs that would interfere with evaluation of efficacy or cause safety problems
* Uncontrolled hypertension, diabetes or hypothyroidism
* Recent cardiac event of procedure
* High baseline CPK levels

Primary outcomes:
measure: Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
Secondary outcomes:
measure: Percentage of subjects achieving:
measure: LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
measure: Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
measure: Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
measure: Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
measure: LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata.
measure: LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
measure: The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment. Change from baseline in apol
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
city: Kallithea, Athens
country: Greece
facility: Pfizer Investigational Site
city: Pireaus
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Kecskemet
country: Hungary
facility: Pfizer Investigational Site
city: Nyíregyháza
country: Hungary
facility: Pfizer Investigational Site
city: Szekszárd
country: Hungary
facility: Pfizer Investigational Site
city: Tullamore
country: Ireland
facility: Pfizer Investigational Site
state: CO. Offlay
city: Tallaght
country: Ireland
facility: Pfizer Investigational Site
state: Dublin
city: Gorey
country: Ireland
facility: Pfizer Investigational Site
state: Wexford
city: Cork
country: Ireland
facility: Pfizer Investigational Site
city: Dublin 8
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Galway
country: Ireland
facility: Pfizer Investigational Site
city: Czestochowa
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Zabrze
country: Poland
facility: Pfizer Investigational Site
city: Aveiro
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Vila Franca de Xira
country: Portugal
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Genève
country: Switzerland
facility: Pfizer Investigational Site
city: Mendrisio
country: Switzerland
facility: Pfizer Investigational Site
city: Zürich
country: Switzerland
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Farsang C, Athyros V, Gaw A; ACTFAST-2 investigators and Steering Committee members. A multicentre, open study to assess the effect of individualizing starting doses of atorvastatin according to baseline LDL-C levels on achieving cholesterol targets: the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST-2) study. Curr Med Res Opin. 2007 Aug;23(8):1945-56. doi: 10.1185/030079907X223242.