HypercholesteremiaPhase 4NCT00329160

Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

A Phase 4 study testing Rosuvastatin and HMG CoA inhibitor in people with Hypercholesteremia, run by AstraZeneca at 27 sites in Japan.

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

The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD). Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Hypercholesteremia
What is being tested?: Rosuvastatin and HMG CoA inhibitor
How many people: 214 participants
Where: 27 sitesJapan
Study dates: Oct 2005to Oct 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Signed written informed consent,
20 to 75 years old,
Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)

Who cannot join

Acute myocardial infarction within 72 hours after the onset,
Heart failure of New York Heart Association (NYHA) Class III or above,
Serious arrhythmia,
Being treated with LDL-apheresis
History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

Japan27 sites

Research Site
Gifu
Research Site
Hamada
Research Site
Hiroshima
Research Site
Ichinomiya
Research Site
Inba-mura
Research Site
Izumi
Research Site
Izumisano
Research Site
Izumo
Research Site
Kagoshima
Research Site
Kanazawa
Research Site
Kasuga
Research Site
Kobe
Research Site
Komaki
Research Site
Konancho
Research Site
Kumamoto
Research Site
Kurume
Research Site
Kyoto
Research Site
Ōmiya
Research Site
Osaka
Research Site
Sapporo
Research Site
Shinjō
Research Site
Shūnan
Research Site
Suita
Research Site
Tokyo
Research Site
Ube
Research Site
Yamaguchi
Research Site
Yokohama

Other trials in Japan

About this study

Official title: A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography

Conditions: Hypercholesteremia
Being tested: Rosuvastatin, HMG CoA inhibitor
Medical subject headings: Hypercholesterolemia

What participants receive

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

RosuvastatinDrug
2.5-20 mg
HMG CoA inhibitorDrug
3-hydroxy-3-methylglutaryl-coenzyme A

What is being measured

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

Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.
Measured: Baseline and 76 weeks

Secondary outcomes (3)

Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Target Lesion indicates Coronary plaque composition of culprit lesions.
Measured: Baseline - 76Weeks
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
Measured: Baseline - 76Weeks
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
Measured: Baseline - 76Weeks

Timeline

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

Oct 2005Oct 2008

First posted24 May 2006 (estimated)
Study startOct 2005
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesteremiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00329160
Sponsor's protocol ID: D3565L00002
Other IDs: 0407E1841
Status last verified: Aug 2011
First submitted: 22 May 2006
Last updated: 31 Aug 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Daida H, Takayama T, Hiro T, Yamagishi M, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M; COSMOS Investigators. High HbA1c levels correlate with reduced plaque regression during statin treatment in patients with stable coronary artery disease: results of the coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Cardiovasc Diabetol. 2012 Jul 25;11:87. doi: 10.1186/1475-2840-11-87.
PubMed 22831708

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

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesteremia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography
ClinicalTrials.gov ID: NCT00329160
Acronym / sponsor ID: D3565L00002
Conditions: Hypercholesteremia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 214 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Shionogi
Study start: Oct 2005
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 24 May 2006 (estimated)
Results: Posted 15 Jul 2011

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: Single group
Masking: None (open label)

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Signed written informed consent,
20 to 75 years old,
Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)

Key exclusion criteria (5 listed)

Acute myocardial infarction within 72 hours after the onset,
Heart failure of New York Heart Association (NYHA) Class III or above,
Serious arrhythmia,
Being treated with LDL-apheresis
History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.

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
Rosuvastatin2.5-20 mg	Drug	–
HMG CoA inhibitor3-hydroxy-3-methylglutaryl-coenzyme A	Drug	–

Primary outcome

Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Time frame: Baseline and 76 weeks
Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.

3 secondary outcomes

Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Time frame: Baseline - 76Weeks
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
Time frame: Baseline - 76Weeks
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
Time frame: Baseline - 76Weeks

Results and safety

Results posted to the registry on 15 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosuvastatin	214	126

Primary outcome: Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)

Time frame: Baseline and 76 weeks. Mean (Standard Deviation). Unit: Percent Change

Measure	Rosuvastatin n = 126
Value	14.1 (-5.066)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosuvastatin	98 of 213 (46%)	588 of 214 (274.8%)	Not reported

Limitations and caveats (from the sponsor): Because there was no placebo arm the net effect of rosuvastatin was not clarified. This study examined only single measurable plaques, which might not represent pan-coronary nature of plaque.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22831708Daida H, Takayama T, Hiro T, Yamagishi M, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M; COSMOS Investigators. High HbA1c levels correlate with reduced plaque regression during statin treatment in patients with stable coronary artery disease: results of the coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Cardiovasc Diabetol. 2012 Jul 25;11:87. doi: 10.1186/1475-2840-11-87.

Related trials for Hypercholesteremia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

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.

Masunori Matsuzaki, MD principal investigator

Yamaguchi University Hospital

27 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 Rosuvastatin and HMG CoA inhibitor in people with Hypercholesteremia, run by AstraZeneca at 27 sites 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 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 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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?

Yes. Results are posted in the registry (first posted 15 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) (time frame: Baseline and 76 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 NCT00329160, 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 31 Aug 2011.