Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST) (ACTFAST)

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

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)

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Dyslipidemia; Peripheral Vascular Disease; Coronary Arteriosclerosis; Cerebrovascular Accident
• Intervention / Treatment: Drug: Atorvastatin (Lipitor)

• Study Type: Interventional
• Enrollment: 2080
• Phase: Phase 4

Contacts and Locations

Study Locations

• • • Pfizer Investigational Site
• Cameroon
  • Ontario
    • Mississauga, Ontario, Cameroon
      • Pfizer Investigational Site
• Canada
  • Quebec, Canada
    • Pfizer Investigational Site
  • Alberta
    • Calgary, Alberta, Canada
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada
      • Pfizer Investigational Site
    • Medicine Hat, Alberta, Canada
      • Pfizer Investigational Site
    • Red Deer, Alberta, Canada
      • Pfizer Investigational Site
  • British Columbia
    • Campbell River, British Columbia, Canada
      • Pfizer Investigational Site
    • Maple Ridge, British Columbia, Canada
      • Pfizer Investigational Site
    • Nanaimo, British Columbia, Canada
      • Pfizer Investigational Site
    • New Westminster, British Columbia, Canada
      • Pfizer Investigational Site
    • Richmond, British Columbia, Canada
      • Pfizer Investigational Site
    • Surrey, British Columbia, Canada
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada
      • Pfizer Investigational Site
    • Vernon, British Columbia, Canada
      • Pfizer Investigational Site
    • Victoria, British Columbia, Canada
      • Pfizer Investigational Site
  • Manitoba
    • Brandon, Manitoba, Canada
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada
      • Pfizer Investigational Site
  • Ontario
    • Ajax, Ontario, Canada
      • Pfizer Investigational Site
    • Brampton, Ontario, Canada
      • Pfizer Investigational Site
    • Burlington, Ontario, Canada
      • Pfizer Investigational Site
    • Cambridge, Ontario, Canada
      • Pfizer Investigational Site
    • Cornwall, Ontario, Canada
      • Pfizer Investigational Site
    • Etobicoke, Ontario, Canada
      • Pfizer Investigational Site
    • Mississauga, Ontario, Canada
      • Pfizer Investigational Site
    • Niagara Falls, Ontario, Canada
      • Pfizer Investigational Site
    • North York, Ontario, Canada
      • Pfizer Investigational Site
    • Orillia, Ontario, Canada
      • Pfizer Investigational Site
    • Oshawa, Ontario, Canada
      • Pfizer Investigational Site
    • Rexdale, Ontario, Canada
      • Pfizer Investigational Site
    • Sarnia, Ontario, Canada
      • Pfizer Investigational Site
    • Scarborough, Ontario, Canada
      • Pfizer Investigational Site
    • Simcoe, Ontario, Canada
      • Pfizer Investigational Site
    • Thunder Bay, Ontario, Canada
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada
      • Pfizer Investigational Site
    • Weston, Ontario, Canada
      • Pfizer Investigational Site
    • Whitby, Ontario, Canada
      • Pfizer Investigational Site
    • Willowdale, Ontario, Canada
      • Pfizer Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada
      • Pfizer Investigational Site
    • Cowansville, Quebec, Canada
      • Pfizer Investigational Site
    • Drummondville, Quebec, Canada
      • Pfizer Investigational Site
    • Joliette, Quebec, Canada
      • Pfizer Investigational Site
    • Laval, Quebec, Canada
      • Pfizer Investigational Site
    • Levis, Quebec, Canada
      • Pfizer Investigational Site
    • Maria, Quebec, Canada
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada
      • Pfizer Investigational Site
    • Newport, Quebec, Canada
      • Pfizer Investigational Site
    • Pointe Claire, Quebec, Canada
      • Pfizer Investigational Site
    • Repentigny, Quebec, Canada
      • Pfizer Investigational Site
    • Saint Hyacinthe, Quebec, Canada
      • Pfizer Investigational Site
    • Sainte Foy, Quebec, Canada
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada
      • Pfizer Investigational Site
    • St-georges (beauce), Quebec, Canada
      • Pfizer Investigational Site
    • St. Lambert, Quebec, Canada
      • Pfizer Investigational Site
    • Thetford Mines, Quebec, Canada
      • Pfizer Investigational Site
    • Vaudreuil, Quebec, Canada
      • Pfizer Investigational Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Pfizer Investigational Site
• Italy
  • Asti, Italy
    • Pfizer Investigational Site
  • Bari, Italy
    • Pfizer Investigational Site
  • Belluno, Italy
    • Pfizer Investigational Site
  • Bologna, Italy
    • Pfizer Investigational Site
  • Bolzano, Italy
    • Pfizer Investigational Site
  • Catania, Italy
    • Pfizer Investigational Site
  • Chieti, Italy
    • Pfizer Investigational Site
  • Ferrara, Italy
    • Pfizer Investigational Site
  • Firenze, Italy
    • Pfizer Investigational Site
  • Foggia, Italy
    • Pfizer Investigational Site
  • Grosseto, Italy
    • Pfizer Investigational Site
  • Napoli, Italy
    • Pfizer Investigational Site
  • Novara, Italy
    • Pfizer Investigational Site
  • Palermo, Italy
    • Pfizer Investigational Site
  • Perugia, Italy
    • Pfizer Investigational Site
  • Potenza, Italy
    • Pfizer Investigational Site
  • Prato, Italy
    • Pfizer Investigational Site
  • Roma, Italy
    • Pfizer Investigational Site
  • Salerno, Italy
    • Pfizer Investigational Site
  • San Donato Milanese, Italy
    • Pfizer Investigational Site
  • Sassari, Italy
    • Pfizer Investigational Site
  • Savona, Italy
    • Pfizer Investigational Site
  • Siena, Italy
    • Pfizer Investigational Site
  • Torino, Italy
    • Pfizer Investigational Site
  • Venezia, Italy
    • Pfizer Investigational Site
  • (le)
    • Tricase, (le), Italy
      • Pfizer Investigational Site
  • (mi)
    • Vimercate, (mi), Italy
      • Pfizer Investigational Site
  • (va)
    • Somma Lombardo, (va), Italy
      • Pfizer Investigational Site
• Spain
  • Avila, Spain
    • Pfizer Investigational Site
  • Barcelona, Spain
    • Pfizer Investigational Site
  • Granada, Spain
    • Pfizer Investigational Site
  • Huelva, Spain
    • Pfizer Investigational Site
  • Jerez de La Frontera, Spain
    • Pfizer Investigational Site
  • Madrid, Spain
    • Pfizer Investigational Site
  • Marbella, Spain
    • Pfizer Investigational Site
  • Sevilla, Spain
    • Pfizer Investigational Site
  • Tarragona, Spain
    • Pfizer Investigational Site
  • Valencia, Spain
    • Pfizer Investigational Site
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain
      • Pfizer Investigational Site
  • Cataluna
    • Girona, Cataluna, Spain
      • Pfizer Investigational Site
  • Vizcaya
    • Galdakao, Vizcaya, Spain
      • Pfizer Investigational Site
• United Kingdom
  • Bath, United Kingdom
    • Pfizer Investigational Site
  • Belfast
    • Newtonabbey, Belfast, United Kingdom
      • Pfizer Investigational Site
  • Buckinghamshire
    • Aylesbury, Buckinghamshire, United Kingdom
      • Pfizer Investigational Site
  • CO Antrim
    • Newtonabbey, CO Antrim, United Kingdom
      • Pfizer Investigational Site
  • Cambs
    • ELY, Cambs, United Kingdom
      • Pfizer Investigational Site
    • Peterborough, Cambs, United Kingdom
      • Pfizer Investigational Site
  • EAST Sussex
    • Hastings, EAST Sussex, United Kingdom
      • Pfizer Investigational Site
  • Fife
    • High Valleyfield, Fife, United Kingdom
      • Pfizer Investigational Site
  • Glasgow
    • Rutherglen, Glasgow, United Kingdom
      • Pfizer Investigational Site
  • Glenrotheshire
    • Leslie, FIFE, Glenrotheshire, United Kingdom
      • Pfizer Investigational Site
  • Middlesex
    • Sunbury on Thames, Middlesex, United Kingdom
      • Pfizer Investigational Site
  • Somerset
    • Frome, Somerset, United Kingdom
      • Pfizer Investigational Site
  • South Glamorgan
    • Barry, South Glamorgan, United Kingdom
      • Pfizer Investigational Site
  • South Yorkshire
    • Doncaster, South Yorkshire, United Kingdom
      • Pfizer Investigational Site
    • Stairfoot, Barnsley, South Yorkshire, United Kingdom
      • Pfizer Investigational Site
  • Surrey
    • Addlestone, Surrey, United Kingdom
      • Pfizer Investigational Site
    • East Horsley, Surrey, United Kingdom
      • Pfizer Investigational Site
  • WEST Midlands
    • Balsall Common, WEST Midlands, United Kingdom
      • Pfizer Investigational Site
  • WEST Sussex
    • Pound Hill, Crawley, WEST Sussex, United Kingdom
      • Pfizer Investigational Site
  • Warks
    • Atherstone, Warks, United Kingdom
      • Pfizer Investigational Site
  • Wilts
    • Chippenham, Wilts, United Kingdom
      • Pfizer Investigational Site
  • Wiltshire
    • Trowbridge, Wiltshire, United Kingdom
      • Pfizer Investigational Site
  • Yorkshire
    • Sheffield, Yorkshire, United Kingdom
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.

Secondary Outcome Measures

Outcome Measure
Percentage of subjects achieving:
LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
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.
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.
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.
LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
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 apolipoprotein-B (Apo-B) and change from baseline in glycosylated hemoglobin (HbA1c) was assessed at 12 weeks.

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): February 1, 2004
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: February 28, 2007
• First Submitted That Met QC Criteria: February 28, 2007
• First Posted (Estimate): March 2, 2007

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Atherosclerosis; Coronary Disease; Lipid Metabolism Disorders; Stroke; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Dyslipidemias; Arteriosclerosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: A2581087