HypercholesterolemiaPhase 4PRECISE-IVUSNCT01043380
Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
A Phase 4 study testing Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] and Lipitor (Atorvastatin) monotherapy in people with Hypercholesterolemia and Coronary Artery Disease, run by Kumamoto University at 1 site in Japan.
Trial summary
The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Hypercholesterolemia, Coronary Artery Disease
- What is being tested?
- Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] and Lipitor (Atorvastatin) monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2010to Sep 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent,
- 30 to 85 years old,
- Plan to undergo PCI and LDL-C >= 100 mg/dL
Who cannot join
- Familial hypercholesterolemia
- Being treated with Zetia (Ezetimibe)
- Being treated with Fibrates
- Renal insufficiency (serum creatinine >= 2.0 mg/dl)
- Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase >= 3-folds of standard value in each institute)
- Undergoing hemodialysis or peritoneal dialysis
Show all 10Show fewer
- Allergic to Lipitor and/or Zetia
- Severe underlying disease
- Lack of decision-making capacity
- Recognized as inadequate by attending doctor
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.
- Conditions
- Hypercholesterolemia, Coronary Artery Disease
- Being tested
- Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe], Lipitor (Atorvastatin) monotherapy
- Keywords
- Heart Diseases, Hyperlipidemia, Atorvastatin, Ezetimibe, Cardiovascular Diseases, Hypercholesterolemia, Coronary Artery Disease, Dyslipidemias, Intravascular Ultrasound
- Medical subject headings
- Hypercholesterolemia, Coronary Artery Disease, Heart Diseases, Hyperlipidemias, Cardiovascular Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]Drug
Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl.
Lipitor (Atorvastatin) monotherapyDrug
The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| LZ group | Experimental | Not described Receives: Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] |
| L group | Active comparator | Not described Receives: Drug: Lipitor (Atorvastatin) monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion
Measured: before randomization & 9-12 months after randomization
Secondary outcomes (11)
Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume
Measured: before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)
Measured: before randomization & 9-12 months after randomization
Percentage changes from baseline to follow-up in serum lipids
Measured: before randomization & 9-12 months after randomization
Correlation between regression of coronary plaque and serum lipids profiles
Measured: before randomization & 9-12 months after randomization
Changes in hs-CRP from baseline to follow-up
Measured: before randomization & 9-12 months after randomization
Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)
Measured: before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the PV of the PCI target lesion
Measured: before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion
Measured: before randomization & 9-12 months after randomization
MACE (cardiac death, non-fatal Q wave and/or non-Q wave myocardial infarction, target vessel revascularization [percutaneous coronary intervention or coronary artery bypass grafting])
Measured: before randomization & 9-12 months after randomization
All-cause death
Measured: before randomization & 9-12 months after randomization
Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)
Measured: before randomization & 9-12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisao Ogawa, Kumamoto University
- Investigators
- Hisao Ogawa, MD, PhD, Study chair, Kumamoto University, Graduate School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043380
- Sponsor's protocol ID
- UMIN000002959
- Acronym
- PRECISE-IVUS
- Status last verified
- Mar 2015
- First submitted
- 5 Jan 2010
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fujisue K, Nagamatsu S, Shimomura H, Yamashita T, Nakao K, Nakamura S, Ishihara M, Matsui K, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Sakamoto K, Izumiya Y, Kaikita K, Hokimoto S, Ogawa H, Tsujita K. Impact of statin-ezetimibe combination on coronary atheroma plaque in patients with and without chronic kidney disease - Sub-analysis of PRECISE-IVUS trial. Int J Cardiol. 2018 Oct 1;268:23-26. doi: 10.1016/j.ijcard.2018.04.051. Epub 2018 Jun 18.
PubMed 29925472Tsujita K, Yamanaga K, Komura N, Sakamoto K, Sugiyama S, Sumida H, Shimomura H, Yamashita T, Oka H, Nakao K, Nakamura S, Ishihara M, Matsui K, Sakaino N, Nakamura N, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Kaikita K, Hokimoto S, Ogawa H; PRECISE-IVUS Investigators. Lipid profile associated with coronary plaque regression in patients with acute coronary syndrome: Subanalysis of PRECISE-IVUS trial. Atherosclerosis. 2016 Aug;251:367-372. doi: 10.1016/j.atherosclerosis.2016.05.025. Epub 2016 May 20.
PubMed 27318866Tsujita K, Sugiyama S, Sumida H, Shimomura H, Yamashita T, Yamanaga K, Komura N, Sakamoto K, Oka H, Nakao K, Nakamura S, Ishihara M, Matsui K, Sakaino N, Nakamura N, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Kaikita K, Hokimoto S, Ogawa H; PRECISE-IVUS Investigators. Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention: The Multicenter Randomized Controlled PRECISE-IVUS Trial. J Am Coll Cardiol. 2015 Aug 4;66(5):495-507. doi: 10.1016/j.jacc.2015.05.065.
PubMed 26227186
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
- ClinicalTrials.gov ID
- NCT01043380
- Acronym / sponsor ID
- PRECISE-IVUS / UMIN000002959
- Conditions
- Hypercholesterolemia, Coronary Artery Disease
- Keywords
- Heart Diseases, Hyperlipidemia, Atorvastatin, Ezetimibe, Cardiovascular Diseases, Hypercholesterolemia, Coronary Artery Disease, Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Jan 2010 (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.
The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LZ group | Experimental | Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] |
| L group | Active comparator | Drug: Lipitor (Atorvastatin) monotherapy |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed written informed consent,
- 30 to 85 years old,
- Plan to undergo PCI and LDL-C >= 100 mg/dL
Key exclusion criteria (10 listed)
- Familial hypercholesterolemia
- Being treated with Zetia (Ezetimibe)
- Being treated with Fibrates
- Renal insufficiency (serum creatinine >= 2.0 mg/dl)
- Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase >= 3-folds of standard value in each institute)
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 |
|---|---|---|
| Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl. | Drug | LZ group |
| Lipitor (Atorvastatin) monotherapyThe dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl. | Drug | L group |
Primary outcome
Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion
Time frame: before randomization & 9-12 months after randomization
11 secondary outcomes
Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume
Time frame: before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)
Time frame: before randomization & 9-12 months after randomization
Percentage changes from baseline to follow-up in serum lipids
Time frame: before randomization & 9-12 months after randomization
Correlation between regression of coronary plaque and serum lipids profiles
Time frame: before randomization & 9-12 months after randomization
Changes in hs-CRP from baseline to follow-up
Time frame: before randomization & 9-12 months after randomization
Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)
Time frame: before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the PV of the PCI target lesion
Time frame: before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion
Time frame: before randomization & 9-12 months after randomization
MACE (cardiac death, non-fatal Q wave and/or non-Q wave myocardial infarction, target vessel revascularization [percutaneous coronary intervention or coronary artery bypass grafting])
Time frame: before randomization & 9-12 months after randomization
All-cause death
Time frame: before randomization & 9-12 months after randomization
Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)
Time frame: before randomization & 9-12 months after randomization
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 1 Apr 2015.
- Derived from this study: PubMed 29925472Fujisue K, Nagamatsu S, Shimomura H, Yamashita T, Nakao K, Nakamura S, Ishihara M, Matsui K, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Sakamoto K, Izumiya Y, Kaikita K, Hokimoto S, Ogawa H, Tsujita K. Impact of statin-ezetimibe combination on coronary atheroma plaque in patients with and without chronic kidney disease - Sub-analysis of PRECISE-IVUS trial. Int J Cardiol. 2018 Oct 1;268:23-26. doi: 10.1016/j.ijcard.2018.04.051. Epub 2018 Jun 18.
- Derived from this study: PubMed 27318866Tsujita K, Yamanaga K, Komura N, Sakamoto K, Sugiyama S, Sumida H, Shimomura H, Yamashita T, Oka H, Nakao K, Nakamura S, Ishihara M, Matsui K, Sakaino N, Nakamura N, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Kaikita K, Hokimoto S, Ogawa H; PRECISE-IVUS Investigators. Lipid profile associated with coronary plaque regression in patients with acute coronary syndrome: Subanalysis of PRECISE-IVUS trial. Atherosclerosis. 2016 Aug;251:367-372. doi: 10.1016/j.atherosclerosis.2016.05.025. Epub 2016 May 20.
- Derived from this study: PubMed 26227186Tsujita K, Sugiyama S, Sumida H, Shimomura H, Yamashita T, Yamanaga K, Komura N, Sakamoto K, Oka H, Nakao K, Nakamura S, Ishihara M, Matsui K, Sakaino N, Nakamura N, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Kaikita K, Hokimoto S, Ogawa H; PRECISE-IVUS Investigators. Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention: The Multicenter Randomized Controlled PRECISE-IVUS Trial. J Am Coll Cardiol. 2015 Aug 4;66(5):495-507. doi: 10.1016/j.jacc.2015.05.065.
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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.
Hisao Ogawa, MD, PhD study chair
Kumamoto University, Graduate School of Medical Sciences
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 Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe] and Lipitor (Atorvastatin) monotherapy in people with Hypercholesterolemia and Coronary Artery Disease, run by Kumamoto 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 10 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 1 Apr 2015. 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?
Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion (time frame: before randomization & 9-12 months after randomization). 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 NCT01043380, which also lists 3 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 1 Apr 2015.