Acute Coronary SyndromePhase 4EASY-FITNCT00700037
Change in Plaque Characteristics With Atorvastatin
A Phase 4 study testing high-dose atorvastatin and low-dose atorvastatin in people with Acute Coronary Syndrome and Atherosclerosis, run by Wakayama Medical University at 1 site in Japan.
Trial summary
To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Atherosclerosis, Dyslipidemia
- What is being tested?
- high-dose atorvastatin and low-dose atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2009to Feb 2012
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI.
- plasma LDL cholesterol levels : >=100mg/dL and ≤160mg/dL
- at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS
Who cannot join
- Patients who will undergo coronary bypass surgery.
- Patients with major complications during treatment of culprit coronary lesions.
- Patients with an atherosclerotic lesion with >50% stenosis at a left main trunk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography
To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.
Read the detailed description
Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.
- Conditions
- Acute Coronary Syndrome, Atherosclerosis, Dyslipidemia
- Being tested
- high-dose atorvastatin, low-dose atorvastatin
- Medical subject headings
- Acute Coronary Syndrome, Atherosclerosis, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose atorvastatinDrug
Also called Lipitor20
20mg/day
low-dose atorvastatinDrug
Also called Lipitor5
5mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Atorvastatin 20mg Receives: Drug: high-dose atorvastatin |
| 2 | Active comparator | atorvastatin 5mg Receives: Drug: low-dose atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrous cap thickness by OCT
Measured: 12 months
Secondary outcomes (1)
macrophage number
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startAug 2009
- Primary completionFeb 2012
- Study completionFeb 2012
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 Acute Coronary SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shigeho Takarada, Wakayama Medical University
- Investigators
- Takashi Akasaka, Principal investigator, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700037
- Sponsor's protocol ID
- wakayamamu08-001
- Acronym
- EASY-FIT
- Status last verified
- Oct 2014
- First submitted
- 13 Jun 2008
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Komukai K, Kubo T, Kitabata H, Matsuo Y, Ozaki Y, Takarada S, Okumoto Y, Shiono Y, Orii M, Shimamura K, Ueno S, Yamano T, Tanimoto T, Ino Y, Yamaguchi T, Kumiko H, Tanaka A, Imanishi T, Akagi H, Akasaka T. Effect of atorvastatin therapy on fibrous cap thickness in coronary atherosclerotic plaque as assessed by optical coherence tomography: the EASY-FIT study. J Am Coll Cardiol. 2014 Dec 2;64(21):2207-17. doi: 10.1016/j.jacc.2014.08.045. Epub 2014 Nov 24.
PubMed 25456755
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT00700037
- Acronym / sponsor ID
- EASY-FIT / wakayamamu08-001
- Conditions
- Acute Coronary Syndrome, Atherosclerosis, Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Jun 2008 (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.
To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.
Detailed description
Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: high-dose atorvastatinAtorvastatin 20mg |
| 2 | Active comparator | Drug: low-dose atorvastatinatorvastatin 5mg |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI.
- plasma LDL cholesterol levels : >=100mg/dL and ≤160mg/dL
- at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS
Key exclusion criteria (3 listed)
- Patients who will undergo coronary bypass surgery.
- Patients with major complications during treatment of culprit coronary lesions.
- Patients with an atherosclerotic lesion with >50% stenosis at a left main trunk.
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 |
|---|---|---|
| high-dose atorvastatinAlso: Lipitor2020mg/day | Drug | 1 |
| low-dose atorvastatinAlso: Lipitor55mg/day | Drug | 2 |
Primary outcome
Fibrous cap thickness by OCT
Time frame: 12 months
1 secondary outcome
macrophage number
Time frame: 12 months
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 29 Oct 2014.
- Derived from this study: PubMed 25456755Komukai K, Kubo T, Kitabata H, Matsuo Y, Ozaki Y, Takarada S, Okumoto Y, Shiono Y, Orii M, Shimamura K, Ueno S, Yamano T, Tanimoto T, Ino Y, Yamaguchi T, Kumiko H, Tanaka A, Imanishi T, Akagi H, Akasaka T. Effect of atorvastatin therapy on fibrous cap thickness in coronary atherosclerotic plaque as assessed by optical coherence tomography: the EASY-FIT study. J Am Coll Cardiol. 2014 Dec 2;64(21):2207-17. doi: 10.1016/j.jacc.2014.08.045. Epub 2014 Nov 24.
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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.
Takashi Akasaka principal investigator
Wakayama Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing high-dose atorvastatin and low-dose atorvastatin in people with Acute Coronary Syndrome and Atherosclerosis, run by Wakayama Medical University at 1 site in Japan.
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 3 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Fibrous cap thickness by OCT (time frame: 12 months). 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 NCT00700037, 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 29 Oct 2014.