Coronary ArteriosclerosisPhase 4NCT00380939
This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.
A Phase 4 study testing Atorvastatin and Pravastatin in people with Coronary Arteriosclerosis, run by Pfizer at 36 sites in United States.
Trial summary
This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Atorvastatin and Pravastatin
- How many people
- 600 participants
- Where
- 36 sitesUnited States
- Study dates
- Apr 1999to Dec 2000
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angiographic evidence of coronary artery disease as defined by a lesion that has at least 20% reduction in luman diameter by visual (angiographic) estimation in any native coronary artery. LDL cholesterol equal to 125mg/dl - 210mg/dl.
Who cannot join
- Patients who are anticipated to undergo coronary bypass surgery or cardiac transplantation during the course of the study. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Allentown, Pennsylvania, 18106
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Auburn, Maine, 04210
Pfizer Investigational Site
BLUE Island, Florida, 60406
Pfizer Investigational Site
Boston, Massachusetts, 02111
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7594
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Cleveland, Ohio, 44195-5066
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Denver, Colorado, 80262
Pfizer Investigational Site
Elryia, Ohio, 44035
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Greensboro, North Carolina, 27403
Pfizer Investigational Site
Greenville, North Carolina, 27858-4354
Pfizer Investigational Site
Kalamazoo, Michigan, 49001
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
New York, New York, 10029
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Providence, Rhode Island, 02903
Pfizer Investigational Site
Providence, Rhode Island, 02906
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Royal Oak, Michigan, 48073
Pfizer Investigational Site
Saint Clair, Michigan, 48080
Pfizer Investigational Site
San Antonio, Texas, 78284-6205
Pfizer Investigational Site
San Diego, California, 92103-8411
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
Shawnee Mission, Kansas, 66204
Pfizer Investigational Site
Toledo, Ohio, 43614
Pfizer Investigational Site
Tulsa, Oklahoma
Pfizer Investigational Site
Williamsville, New York, 14221
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Prospective, Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Atorvastatin Versus Pravastatin on the Progression and Quantification of Coronary Atherosclerotic Lesions as Measured by Intravascular Ultrasound (REVERSAL)
This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- Atorvastatin, Pravastatin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
PravastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter is the percent change in total plaque volume for all slices of anatomically comparable segments of the target coronary artery from baseline to month 18.
The primary efficacy parameter for brachial artery vasoactivity is the nominal change (month 3 - baseline) in the percent arterial diameter change.
Secondary outcomes (2)
The nominal change (month 18 - baseline) in total plaque volume as measured by the sum of plaque areas for all slices of anatomically comparable segments of the target coronary artery.
Changes in brachial artery vasoactivity will be correlated with changes in total cholesterol, LDL-C, triglyceride and apolipoprotein B levels following 3 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startApr 1999
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380939
- Sponsor's protocol ID
- 0981-400-314
- Status last verified
- Nov 2006
- First submitted
- 26 Sep 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Atorvastatin Versus Pravastatin on the Progression and Quantification of Coronary Atherosclerotic Lesions as Measured by Intravascular Ultrasound (REVERSAL)
- ClinicalTrials.gov ID
- NCT00380939
- Acronym / sponsor ID
- 0981-400-314
- Conditions
- Coronary Arteriosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Study completion
- Dec 2000
- First posted
- 27 Sep 2006 (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.
This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Angiographic evidence of coronary artery disease as defined by a lesion that has at least 20% reduction in luman diameter by visual (angiographic) estimation in any native coronary artery. LDL cholesterol equal to 125mg/dl - 210mg/dl.
Key exclusion criteria (1 listed)
- Patients who are anticipated to undergo coronary bypass surgery or cardiac transplantation during the course of the study. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction.
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 | Drug | – |
| Pravastatin | Drug | – |
Primary outcome
The primary efficacy parameter is the percent change in total plaque volume for all slices of anatomically comparable segments of the target coronary artery from baseline to month 18.
The primary efficacy parameter for brachial artery vasoactivity is the nominal change (month 3 - baseline) in the percent arterial diameter change.
2 secondary outcomes
The nominal change (month 18 - baseline) in total plaque volume as measured by the sum of plaque areas for all slices of anatomically comparable segments of the target coronary artery.
Changes in brachial artery vasoactivity will be correlated with changes in total cholesterol, LDL-C, triglyceride and apolipoprotein B levels following 3 months of treatment.
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 4 Dec 2006.
- 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
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and Pravastatin in people with Coronary Arteriosclerosis, run by Pfizer at 36 sites in United States.
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 1 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 4 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. 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?
The primary efficacy parameter is the percent change in total plaque volume for all slices of anatomically comparable segments of the target coronary artery from baseline to month 18.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2006.