Coronary ArteriosclerosisPhase 4ACTFASTNCT00442845

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

A Phase 4 study testing Atorvastatin (Lipitor) in people with Coronary Arteriosclerosis and Diabetes Mellitus, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 121 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident
What is being tested?: Atorvastatin (Lipitor)
How many people: 2,080 participants
Where: 121 sitesin 6 countries
Study dates: Jan 2003to Feb 2004
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

121 sites in 6 countries.

Country

City, postcode or hospital

121 sites in 6 countries

Canada55 sites

Pfizer Investigational Site
Ajax, Ontario
Pfizer Investigational Site
Brampton, Ontario
Pfizer Investigational Site
Brandon, Manitoba
Pfizer Investigational Site
Burlington, Ontario
Pfizer Investigational Site
Calgary, Alberta
Pfizer Investigational Site
Cambridge, Ontario
Pfizer Investigational Site
Campbell River, British Columbia
Pfizer Investigational Site
Chicoutimi, Quebec
Pfizer Investigational Site
Cornwall, Ontario
Pfizer Investigational Site
Cowansville, Quebec
Pfizer Investigational Site
Drummondville, Quebec
Pfizer Investigational Site
Edmonton, Alberta
Pfizer Investigational Site
Etobicoke, Ontario
Pfizer Investigational Site
Joliette, Quebec
Pfizer Investigational Site
Laval, Quebec
Pfizer Investigational Site
Lévis, Quebec
Pfizer Investigational Site
Maple Ridge, British Columbia
Pfizer Investigational Site
Maria, Quebec
Pfizer Investigational Site
Medicine Hat, Alberta
Pfizer Investigational Site
Mississauga, Ontario
Pfizer Investigational Site
Montreal, Quebec
Pfizer Investigational Site
Nanaimo, British Columbia
Pfizer Investigational Site
New Westminster, British Columbia
Pfizer Investigational Site
Newport, Quebec
Pfizer Investigational Site
Niagara Falls, Ontario
Pfizer Investigational Site
North YORK, Ontario
Pfizer Investigational Site
Orillia, Ontario
Pfizer Investigational Site
Oshawa, Ontario
Pfizer Investigational Site
Pointe-Claire, Quebec
Pfizer Investigational Site
Québec
Pfizer Investigational Site
Red Deer, Alberta
Pfizer Investigational Site
Repentigny, Quebec
Pfizer Investigational Site
Rexdale, Ontario
Pfizer Investigational Site
Richmond, British Columbia
Pfizer Investigational Site
Saint-Hyacinthe, Quebec
Pfizer Investigational Site
Saint-Lambert, Quebec
Pfizer Investigational Site
Sainte-Foy, Quebec
Pfizer Investigational Site
Sarnia, Ontario
Pfizer Investigational Site
Saskatoon, Saskatchewan
Pfizer Investigational Site
Scarborough Village, Ontario
Pfizer Investigational Site
Sherbrooke, Quebec
Pfizer Investigational Site
Simcoe, Ontario
Pfizer Investigational Site
St-georges (beauce), Quebec
Pfizer Investigational Site
Surrey, British Columbia
Pfizer Investigational Site
Thetford-Mines, Quebec
Pfizer Investigational Site
Thunder Bay, Ontario
Pfizer Investigational Site
Toronto, Ontario
Pfizer Investigational Site
Vancouver, British Columbia
Pfizer Investigational Site
Vaudreuil, Quebec
Pfizer Investigational Site
Vernon, British Columbia
Pfizer Investigational Site
Victoria, British Columbia
Pfizer Investigational Site
Weston, Ontario
Pfizer Investigational Site
Whitby, Ontario
Pfizer Investigational Site
Willowdale, Ontario
Pfizer Investigational Site
Winnipeg, Manitoba

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Italy28 sites

Pfizer Investigational Site
Asti
Pfizer Investigational Site
Bari
Pfizer Investigational Site
Belluno
Pfizer Investigational Site
Bologna
Pfizer Investigational Site
Bolzano
Pfizer Investigational Site
Catania
Pfizer Investigational Site
Chieti
Pfizer Investigational Site
Ferrara
Pfizer Investigational Site
Florence
Pfizer Investigational Site
Foggia
Pfizer Investigational Site
Grosseto
Pfizer Investigational Site
Naples
Pfizer Investigational Site
Novara
Pfizer Investigational Site
Palermo
Pfizer Investigational Site
Perugia
Pfizer Investigational Site
Potenza
Pfizer Investigational Site
Prato
Pfizer Investigational Site
Roma
Pfizer Investigational Site
Salerno
Pfizer Investigational Site
San Donato Milanese
Pfizer Investigational Site
Sassari
Pfizer Investigational Site
Savona
Pfizer Investigational Site
Siena
Pfizer Investigational Site
Somma Lombardo, (VA)
Pfizer Investigational Site
Torino
Pfizer Investigational Site
Tricase, (LE)
Pfizer Investigational Site
Venezia
Pfizer Investigational Site
Vimercate, (MI)

Other trials in Italy

United Kingdom23 sites

Pfizer Investigational Site
Addlestone, Surrey
Pfizer Investigational Site
Atherstone, Warks
Pfizer Investigational Site
Aylesbury, Buckinghamshire
Pfizer Investigational Site
Balsall Common, WEST Midlands
Pfizer Investigational Site
Barry, South Glamorgan
Pfizer Investigational Site
Bath
Pfizer Investigational Site
Chippenham, Wilts
Pfizer Investigational Site
Doncaster, South Yorkshire
Pfizer Investigational Site
East Horsley, Surrey
Pfizer Investigational Site
Ely, Cambs
Pfizer Investigational Site
Frome, Somerset
Pfizer Investigational Site
Hastings, EAST Sussex
Pfizer Investigational Site
High Valleyfield, FIFE
Pfizer Investigational Site
Leslie, FIFE, Glenrotheshire
Pfizer Investigational Site
Newtonabbey, Belfast
Pfizer Investigational Site
Newtonabbey, CO Antrim
Pfizer Investigational Site
Peterborough, Cambs
Pfizer Investigational Site
Pound Hill, Crawley, WEST Sussex
Pfizer Investigational Site
Rutherglen, Glasgow
Pfizer Investigational Site
Sheffield, Yorkshire
Pfizer Investigational Site
Stairfoot, Barnsley, South Yorkshire
Pfizer Investigational Site
Sunbury-on-Thames, Middlesex
Pfizer Investigational Site
Trowbridge, Wiltshire

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Spain13 sites

Pfizer Investigational Site
Ávila
Pfizer Investigational Site
Barcelona
Pfizer Investigational Site
Galdakao, Vizcaya
Pfizer Investigational Site
Girona, Catalonia
Pfizer Investigational Site
Granada
Pfizer Investigational Site
Huelva
Pfizer Investigational Site
Jerez de la Frontera
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona
Pfizer Investigational Site
Madrid
Pfizer Investigational Site
Marbella
Pfizer Investigational Site
Seville
Pfizer Investigational Site
Tarragona
Pfizer Investigational Site
Valencia

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Cameroon1 site

Pfizer Investigational Site
Mississauga, Ontario

Other trials in Cameroon

Location not given1 site

Pfizer Investigational Site

About this study

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

Conditions: Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia, Peripheral Vascular Disease
Being tested: Atorvastatin (Lipitor)
Medical subject headings: Coronary Artery Disease, Diabetes Mellitus, Type 2, Stroke, Dyslipidemias, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atorvastatin (Lipitor)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Feb 2004

First posted2 Mar 2007 (estimated)
Study startJan 2003
Primary completionFeb 2004
Study completionFeb 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,080 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00442845
Sponsor's protocol ID: A2581087
Acronym: ACTFAST
Status last verified: Feb 2021
First submitted: 28 Feb 2007
Last updated: 18 Feb 2021
Results posted: No

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.
PubMed 21610204
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.
PubMed 19217176

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00442845
Acronym / sponsor ID: ACTFAST / A2581087
Conditions: Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia, Peripheral Vascular Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,080 participants
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2003
Primary completion: Feb 2004 (actual)
Study completion: Feb 2004 (actual)
First posted: 2 Mar 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atorvastatin (Lipitor)	Drug	–

Primary outcome

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

9 secondary outcomes

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Derived from this study: PubMed 21610204Gupta 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.
Derived from this study: PubMed 19217176Gensini 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
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RecruitingEarly Phase 1
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

121 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in Canada, Italy, United Kingdom, Spain, Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00442845, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.