Coronary ArteriosclerosisPhase 4ACTFAST 2NCT00442325
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
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 32 sites in 9 countries.
Trial 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) 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
- 595 participants
- Where
- 32 sitesin 9 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
32 sites in 9 countries.
32 sites in 9 countries
Ireland6 sites
Pfizer Investigational Site
Cork
Pfizer Investigational Site
Dublin
Pfizer Investigational Site
Galway
Pfizer Investigational Site
Gorey, Wexford
Pfizer Investigational Site
Tallaght, Dublin
Pfizer Investigational Site
Tullamore, CO. Offlay
Hungary5 sites
Pfizer Investigational Site
Budapest
Pfizer Investigational Site
Gyula
Pfizer Investigational Site
Kecskemét
Pfizer Investigational Site
Nyíregyháza
Pfizer Investigational Site
Szekszárd
Poland5 sites
Pfizer Investigational Site
Częstochowa
Pfizer Investigational Site
Poznan
Pfizer Investigational Site
Warsaw
Pfizer Investigational Site
Wroclaw
Pfizer Investigational Site
Zabrze
Greece4 sites
Pfizer Investigational Site
Ioannina
Pfizer Investigational Site
Kallithea, Athens
Pfizer Investigational Site
Pireaus
Pfizer Investigational Site
Thessaloniki
Portugal4 sites
Pfizer Investigational Site
Aveiro
Pfizer Investigational Site
Lisbon
Pfizer Investigational Site
Porto
Pfizer Investigational Site
Vila Franca de Xira
Switzerland4 sites
Pfizer Investigational Site
Bern
Pfizer Investigational Site
Geneva
Pfizer Investigational Site
Mendrisio
Pfizer Investigational Site
Zurich
Slovakia2 sites
Pfizer Investigational Site
Bratislava
Pfizer Investigational Site
Košice
Location not given1 site
Pfizer Investigational Site
About this study
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.
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)
- 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 (8)
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 apol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startJan 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 595 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442325
- Sponsor's protocol ID
- A2581095
- Acronym
- ACTFAST 2
- Status last verified
- Feb 2021
- First submitted
- 28 Feb 2007
- Last updated
- 18 Feb 2021
- Results posted
- No
Publications
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.
PubMed 17626713
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 (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.
- ClinicalTrials.gov ID
- NCT00442325
- Acronym / sponsor ID
- ACTFAST 2 / A2581095
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia, Peripheral Vascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Feb 2004
- First posted
- 1 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.
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)
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 (5 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.
8 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 apol
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 17626713Farsang 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
32 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 32 sites in 9 countries.
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 5 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 32 sites in Ireland, Hungary, Poland, Greece, Portugal and 3 more countries. 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 NCT00442325, which also lists 1 linked publication.
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.