Clinical trial NCT00442845: Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
Official title: ACTFAST: 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: 2007-03-02
Enrollment: 2080
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: 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.
measure: Change from baseline in apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks.
Other outcomes:
Locations:
city: Mississauga
country: Cameroon
facility: Pfizer Investigational Site
state: Ontario
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Medicine Hat
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Campbell River
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Maple Ridge
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Nanaimo
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: New Westminster
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Richmond
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vernon
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Brandon
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Ajax
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Cambridge
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Cornwall
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North York
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Orillia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Rexdale
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Simcoe
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Weston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Whitby
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Willowdale
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Cowansville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Drummondville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Joliette
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Levis
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Maria
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Newport
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Repentigny
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saint Hyacinthe
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sainte Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-georges (beauce)
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St. Lambert
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Thetford Mines
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Vaudreuil
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Tricase
country: Italy
facility: Pfizer Investigational Site
state: (le)
city: Vimercate
country: Italy
facility: Pfizer Investigational Site
state: (mi)
city: Somma Lombardo
country: Italy
facility: Pfizer Investigational Site
state: (va)
city: Asti
country: Italy
facility: Pfizer Investigational Site
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Belluno
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bolzano
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Chieti
country: Italy
facility: Pfizer Investigational Site
city: Ferrara
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Foggia
country: Italy
facility: Pfizer Investigational Site
city: Grosseto
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Novara
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Potenza
country: Italy
facility: Pfizer Investigational Site
city: Prato
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Salerno
country: Italy
facility: Pfizer Investigational Site
city: San Donato Milanese
country: Italy
facility: Pfizer Investigational Site
city: Sassari
country: Italy
facility: Pfizer Investigational Site
city: Savona
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Venezia
country: Italy
facility: Pfizer Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Girona
country: Spain
facility: Pfizer Investigational Site
state: Cataluna
city: Galdakao
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Avila
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Huelva
country: Spain
facility: Pfizer Investigational Site
city: Jerez de La Frontera
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Marbella
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Tarragona
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Newtonabbey
country: United Kingdom
facility: Pfizer Investigational Site
state: Belfast
city: Aylesbury
country: United Kingdom
facility: Pfizer Investigational Site
state: Buckinghamshire
city: ELY
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambs
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambs
city: Newtonabbey
country: United Kingdom
facility: Pfizer Investigational Site
state: CO Antrim
city: Hastings
country: United Kingdom
facility: Pfizer Investigational Site
state: EAST Sussex
city: High Valleyfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Fife
city: Rutherglen
country: United Kingdom
facility: Pfizer Investigational Site
state: Glasgow
city: Leslie, FIFE
country: United Kingdom
facility: Pfizer Investigational Site
state: Glenrotheshire
city: Sunbury on Thames
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Frome
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: Barry
country: United Kingdom
facility: Pfizer Investigational Site
state: South Glamorgan
city: Doncaster
country: United Kingdom
facility: Pfizer Investigational Site
state: South Yorkshire
city: Stairfoot, Barnsley
country: United Kingdom
facility: Pfizer Investigational Site
state: South Yorkshire
city: Addlestone
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: East Horsley
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Atherstone
country: United Kingdom
facility: Pfizer Investigational Site
state: Warks
city: Balsall Common
country: United Kingdom
facility: Pfizer Investigational Site
state: WEST Midlands
city: Pound Hill, Crawley
country: United Kingdom
facility: Pfizer Investigational Site
state: WEST Sussex
city: Trowbridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Chippenham
country: United Kingdom
facility: Pfizer Investigational Site
state: Wilts
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: Yorkshire
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gupta M, Martineau P, Tran T, Despres JP, Gaw A, de Teresa E, Farsang C, Gensini GF, Leiter LA, Blanco-Colio LM, Egido J, Langer A; ACTFAST investigators. Low-density lipoprotein cholesterol and high-sensitivity C-reactive protein lowering with atorvastatin in patients of South Asian compared with European origin: insights from the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST) study. J Clin Pharmacol. 2012 Jun;52(6):850-8. doi: 10.1177/0091270011407196. Epub 2011 May 24.
citation: Gensini GF, Gori AM, Dilaghi B, Rostagno C, Gaw A, Blanco-Colio LM, de Teresa E, Egido J, Farsang C, Leiter LA, Martineau P, Nozza A, Langer A; Achieve Cholesterol Targets Fast withAtorvastatin Stratified Titration Investigators. Effect of atorvastatin on circulating hsCRP concentrations: a sub-study of the achieve cholesterol targets fast with atorvastatin stratified titration (ACTFAST) study. Int J Cardiol. 2010 Jul 23;142(3):257-64. doi: 10.1016/j.ijcard.2008.12.213. Epub 2009 Feb 12.