Coronary Artery DiseasePhase 4NCT03657758
Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]
A Phase 4 study testing EPA and rosuvastatin and High dose rosuvastatin in people with Coronary Artery Disease and Angina Pectoris, run by Kobe University at 1 site in Japan.
Trial summary
This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- EPA and rosuvastatin and High dose rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteJapan
- Study dates
- 17 Sep 2018to 31 Aug 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 20 years
- Patients implanted everolimus-eluting stent(EES) neoatherosccrelosis with neoatherosclerosis by OCT
- LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin
Who cannot join
- Patients taking omega 3 fatty acid before randomization
- Patients allergic to rosuvastatin or eicosapentaenoic acid
- Patients with a history of hemorrhagic stroke
- Patients taking anti cancer agent
- Patients undergoing LDL apheresis
- Patients with severe liver disease or severe kidney disease
Show all 10Show fewer
- Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin
- Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid
- Patients performed percutaneous coronary intervention with restenosis of target lesion
- Pregnant women or patients with possibility of Pregnancy or nursing woman
Trial locations and contacts
1 site in 1 country.
Japan1 site
Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyōgo, 650-0017
Hiromasa Otake, ph.D, +81-78-382-5846, hotake@med.kobe-u.ac.jp
About this study
Official title: Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT
This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.
Read the detailed description
Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified.
So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.
However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety.
Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure.
This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- EPA and rosuvastatin, High dose rosuvastatin
- Keywords
- eicosapentaenoic acid, OCT, neoatherosclerosis
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA and rosuvastatinDrug
To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
High dose rosuvastatinDrug
To take high dose rosuvastatin (10mg/day) for ９ months.
| Study group | Role | What they receive |
|---|---|---|
| EPA and statin therapy group | Active comparator | After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months. Receives: Drug: EPA and rosuvastatin |
| High dose statin therapy group | Active comparator | After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months. Receives: Drug: High dose rosuvastatin |
| low dose statin therapy group | No intervention | After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in lipid index
mean lipid arc ✕ lipid length
Measured: 9 months
Secondary outcomes (9)
MACE
Major cerebro-cardiovascular events（Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death)
Measured: 9 months
The change in minimum lumen area
OCT parameter
Measured: 9 months
The change in average neointimal thickness
OCT parameter
Measured: 9 months
The change in lipid arc
OCT parameter
Measured: 9 months
The change in lipid length
OCT parameter
Measured: 9 months
The change in thin cap fibroatheroma
OCT parameter
Measured: 9 months
The change in macrophage grade
OCT parameter
Measured: 9 months
The change in plaque volume
Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter
Measured: 9 months
The change in max Lipid-core burden index
NIRS-IVUS parameter
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start17 Sep 2018 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hiromasa Otake, Kobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657758
- Sponsor's protocol ID
- 300027
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT
- ClinicalTrials.gov ID
- NCT03657758
- Acronym / sponsor ID
- 300027
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- eicosapentaenoic acid, OCT, neoatherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2018 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 5 Sep 2018 (actual)
- 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 aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.
Detailed description
Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified.
So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.
However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety.
Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure.
This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPA and statin therapy group | Active comparator | Drug: EPA and rosuvastatinAfter randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months. |
| High dose statin therapy group | Active comparator | Drug: High dose rosuvastatinAfter randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months. |
| low dose statin therapy group | No intervention | –After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 20 years
- Patients implanted everolimus-eluting stent(EES) neoatherosccrelosis with neoatherosclerosis by OCT
- LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin
Key exclusion criteria (10 listed)
- Patients taking omega 3 fatty acid before randomization
- Patients allergic to rosuvastatin or eicosapentaenoic acid
- Patients with a history of hemorrhagic stroke
- Patients taking anti cancer agent
- Patients undergoing LDL apheresis
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 |
|---|---|---|
| EPA and rosuvastatinTo take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months. | Drug | EPA and statin therapy group |
| High dose rosuvastatinTo take high dose rosuvastatin (10mg/day) for ９ months. | Drug | High dose statin therapy group |
Primary outcome
The change in lipid index
Time frame: 9 months
mean lipid arc ✕ lipid length
9 secondary outcomes
MACE
Time frame: 9 months
The change in minimum lumen area
Time frame: 9 months
The change in average neointimal thickness
Time frame: 9 months
The change in lipid arc
Time frame: 9 months
The change in lipid length
Time frame: 9 months
The change in thin cap fibroatheroma
Time frame: 9 months
The change in macrophage grade
Time frame: 9 months
The change in plaque volume
Time frame: 9 months
The change in max Lipid-core burden index
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
Related trials for Coronary Artery Disease
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
RecruitingPhase 4
The Bridging Antiplatelet Therapy With Cangrelor 2 Study
Coronary Arterial Disease (CAD)
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
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 EPA and rosuvastatin and High dose rosuvastatin in people with Coronary Artery Disease and Angina Pectoris, run by Kobe 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: status not confirmed, as of the sponsor's last update on 18 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiromasa Otake, ph.D (+81-78-382-5846, hotake@med.kobe-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in lipid index (time frame: 9 months). 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 18 Sep 2018.