Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration (CANACTFAST)

A Multicenter, 12 Week Treatment Single Step Titration Open-Label Study Assessing The % Of Patients Achieving Ldl-C Target With Atorvastatin Starting Doses Of 10mg, 20mg, 40mg and 80mg.

The objective of this study is to assess the effectiveness of an atorvastatin treatment regimen involving starting doses between 10 and 80 mg, followed by a single-step titration (except for subjects started at 80mg), if required

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: atorvastatin

• Study Type: Interventional
• Enrollment: 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1S 2L6
    • Pfizer Investigational Site
  • St. John's, Canada, A1E 2C2
    • Pfizer Investigational Site
  • St. John's, Canada, A1E 2E2
    • Pfizer Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2E 7C5
      • Pfizer Investigational Site
    • Calgary, Alberta, Canada, T3E 0C5
      • Pfizer Investigational Site
    • Calgary, Alberta, Canada, T3G 3J9
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T5A 4L8
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T5K 2A2
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T5N 2N8
      • Pfizer Investigational Site
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
      • Pfizer Investigational Site
    • Coquitlam, British Columbia, Canada, V3K 3V9
      • Pfizer Investigational Site
    • Kelowna, British Columbia, Canada, V1Y 2H4
      • Pfizer Investigational Site
    • Langley, British Columbia, Canada, V3A 4H9
      • Pfizer Investigational Site
    • Surrey, British Columbia, Canada, V3R 3P1
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 3J5
      • Pfizer Investigational Site
    • Victoria, British Columbia, Canada, V8T 3P2
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 3P4
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Pfizer Investigational Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Pfizer Investigational Site
    • Rothesay, New Brunswick, Canada, E2E 2R2
      • Pfizer Investigational Site
    • Saint John, New Brunswick, Canada, E2K 2T8
      • Pfizer Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Pfizer Investigational Site
    • Halifax, Nova Scotia, Canada, B3H 1Y6
      • Pfizer Investigational Site
    • Halifax, Nova Scotia, Canada, B3K 5R3
      • Pfizer Investigational Site
    • Halifax, B3K 5R3, Nova Scotia, Canada
      • Pfizer Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6T 3J1
      • Pfizer Investigational Site
    • Burlington, Ontario, Canada, L7M 4Y1
      • Pfizer Investigational Site
    • Courtice, Ontario, Canada, L1E 3C3
      • Pfizer Investigational Site
    • Downsview, Ontario, Canada, M3M 3E5
      • Pfizer Investigational Site
    • Fort Erie, Ontario, Canada, L2A1Z3
      • Pfizer Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Pfizer Investigational Site
    • Hawkesbury, Ontario, Canada, K6A 1A1
      • Pfizer Investigational Site
    • Kitchener, Ontario, Canada, N2C 2N9
      • Pfizer Investigational Site
    • Lindsay, Ontario, Canada, K9V 6C5
      • Pfizer Investigational Site
    • Markham, Ontario, Canada, L6B 1A1
      • Pfizer Investigational Site
    • Midland, Ontario, Canada, L4R 4P4
      • Pfizer Investigational Site
    • Napanee, Ontario, Canada, K7R 2G3
      • Pfizer Investigational Site
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Pfizer Investigational Site
    • Niagara Falls, Ontario, Canada, L2E 7H1
      • Pfizer Investigational Site
    • North Bay, Ontario, Canada, P1B 2H3
      • Pfizer Investigational Site
    • North York, Ontario, Canada, M3J 1N2
      • Pfizer Investigational Site
    • Oshawa, Ontario, Canada, L1H 1B9
      • Pfizer Investigational Site
    • Oshawa, Ontario, Canada, L1J 2K9
      • Pfizer Investigational Site
    • Ottawa, Ontario, Canada, K1C 1S6
      • Pfizer Investigational Site
    • Saint Catherines, Ontario, Canada, L2N 7H8
      • Pfizer Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Pfizer Investigational Site
    • St. Catherines, Ontario, Canada, L2S 3V7
      • Pfizer Investigational Site
    • Thornhill, Ontario, Canada, L3T 4X1
      • Pfizer Investigational Site
    • Thunder Bay, Ontario, Canada, P7E 4Z3
      • Pfizer Investigational Site
    • Thunder Bay, Ontario, Canada, P7E 6E7
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5C 2T2
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5G 2C4
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M8V 3X8
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M9W 4L6
      • Pfizer Investigational Site
    • Windsor, Ontario, Canada, N8X 1K4
      • Pfizer Investigational Site
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 1L2
      • Pfizer Investigational Site
    • Montague, Prince Edward Island, Canada, C0A 1R0
      • Pfizer Investigational Site
  • Quebec
    • Amos, Quebec, Canada, J9T 1T8
      • Pfizer Investigational Site
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Pfizer Investigational Site
    • Cowansville, Quebec, Canada, J2K 2X9
      • Pfizer Investigational Site
    • Greenfield Park, Quebec, Canada, J4V 2G8
      • Pfizer Investigational Site
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Pfizer Investigational Site
    • Greenfield Park, Quebec, Canada, J4V2H1
      • Pfizer Investigational Site
    • Laval, Quebec, Canada, H7N 2k2
      • Pfizer Investigational Site
    • Laval, Quebec, Canada, H7T 2P5
      • Pfizer Investigational Site
    • Laval, Quebec, Canada, H7V 2W3
      • Pfizer Investigational Site
    • Le Gardeur, Quebec, Canada, J5Z 3C4
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3S 2W1
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H4N 2W2
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H4V 2R8
      • Pfizer Investigational Site
    • Plessisville, Quebec, Canada, G6L 3J1
      • Pfizer Investigational Site
    • Saint-Eustache, Quebec, Canada, J7P 2V1
      • Pfizer Investigational Site
    • Salaberry Du Valleyfield, Quebec, Canada, J6S 4Z5
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 4J6
      • Pfizer Investigational Site
    • St. Leonard, Quebec, Canada, H1S 3A9
      • Pfizer Investigational Site
    • Ste. Foy, Quebec, Canada, G1V 4G2
      • Pfizer Investigational Site
    • Vaudreuil, Quebec, Canada, J7V 8P9
      • Pfizer Investigational Site
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 3X1
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7H 0W6
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7K 1N8
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7K 7H9
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7L 2W1
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 30 to 79 years old
• Triglyceride level 6.8 mmol/L at screening
• LDL-C of 5.7 mmol/L at screening

Exclusion Criteria:

• Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception. The latter are defined as: abstinence, surgical sterilization, oral contraceptives for at least 3 cycles, intrauterine device, implant, depot injection, or barrier method in conjunction with contraceptive foam or jelly.
• Subjects whose blood cholesterol levels are controlled (LDL-C targets) with statins other than atorvastatin
• Subjects receiving statin doses higher than the following: 10-40mg for simvastatin , 20-40mg for fluvastatin, pravastatin and lovastatin and 10-20 mg for rosuvastatin. Subjects already treated with atorvastatin at the time of screening are not eligible unless atorvastatin has been discontinued at least 2 months prior to screening
• Subjects receiving 2 or more lipid lowering agents are excluded (statins + resins or fibrates or niacin or fish oils)

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 their LDL-C target after 12 weeks of treatment according to their 10-year CHD risk category (based on the new canadian guidelines on the management and treatment of dyslipidemia).

Secondary Outcome Measures

Outcome Measure
The global proportion (%) of patients reaching targets when risk categories are combined The proportion (%) of subjects achieving BOTH their LDL-C and TC/HDL-C ratio targets after 6 and 12 weeks of treatment, globally and according to their 10-year

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Ur E, Langer A, Rabkin SW, Calciu CD, Leiter LA; CanACTFAST Study Investigators. Achieving cholesterol targets by individualizing starting doses of statin according to baseline low-density lipoprotein cholesterol and coronary artery disease risk category: the CANadians Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (CanACTFAST) study. Can J Cardiol. 2010 Feb;26(2):80-6. doi: 10.1016/s0828-282x(10)70003-9.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion: December 6, 2022
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: September 6, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (Estimate): September 8, 2005

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

• Keywords: (D006937)
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: A2581091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No