Coronary Artery DiseaseNCT02155530
COmparison and Modification in Neointimal Pattern Assessed by Optical Coherence Tomography With High Versus Moderate Efficacy Statin Treatment After Drug Eluting Stent Implantation: COMPASS Trial
A study testing Atorvastatin 40mg and pravastatin 20 mg in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Atorvastatin 40mg and pravastatin 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 20 years old
- Patients who received OCT related to clinical needs or the end point of other study
- Patients who received DES within 1 year before OCT evaluation
- Patients with homogenous or hetero neointimal pattern by OCT
- Non-statin user and moderate or low efficacy statin user
Who cannot join
- Refuse to participate
- Contraindication to statin treatment
- Women with current or potential childbearing
- Life expectancy <1 year
- High efficacy statin user (Atorvastatin 80mg or Rosuvastatin 20mg)
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that Atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in patients with DES implantation.
- Conditions
- Coronary Artery Disease
- Being tested
- Atorvastatin 40mg, pravastatin 20 mg
- 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.
Atorvastatin 40mgDrug
Also called Atorvastatin 40 mg (Homogeneous)
homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
pravastatin 20 mgDrug
Also called Pravastatin 20 mg (Homogeneous)
Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group
| Study group | Role | What they receive |
|---|---|---|
| High efficacy statin group (homogeneous) | Experimental | homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group Receives: Drug: Atorvastatin 40mg |
| Low efficacy statin group (homogeneous) | Active comparator | homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group Receives: Drug: pravastatin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of neointimal patterns assessed by 1-year followed OCT
Qualitative neointimal pattern measured by OCT such as restenotic tissue structure
Measured: at 1 year
Secondary outcomes (2)
stent coverage and neointimal thickness
Change of stent coverage and neointimal thickness assessed by 1-year followed OCT
Measured: at 1 year
Major adverse cardiac events
MACE (Major adverse cardiac events) including cardiovascular/unexpected mortality, non-fatal myocardial infarction, target lesion revascularization
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionJun 2016
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.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155530
- Sponsor's protocol ID
- 4-2014-0185
- Status last verified
- Jul 2016
- First submitted
- 26 May 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparison and Modification in Neointimal Pattern Assessed by Optical Coherence Tomography With High Versus Moderate Efficacy Statin Treatment After Drug Eluting Stent Implantation: COMPASS Trial
- ClinicalTrials.gov ID
- NCT02155530
- Acronym / sponsor ID
- 4-2014-0185
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Jun 2014 (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 is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that Atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in patients with DES implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High efficacy statin group (homogeneous) | Experimental | Drug: Atorvastatin 40mghomogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group |
| Low efficacy statin group (homogeneous) | Active comparator | Drug: pravastatin 20 mghomogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is ≥ 20 years old
- Patients who received OCT related to clinical needs or the end point of other study
- Patients who received DES within 1 year before OCT evaluation
- Patients with homogenous or hetero neointimal pattern by OCT
- Non-statin user and moderate or low efficacy statin user
Key exclusion criteria (5 listed)
- Refuse to participate
- Contraindication to statin treatment
- Women with current or potential childbearing
- Life expectancy <1 year
- High efficacy statin user (Atorvastatin 80mg or Rosuvastatin 20mg)
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 40mgAlso: Atorvastatin 40 mg (Homogeneous)homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group | Drug | High efficacy statin group (homogeneous) |
| pravastatin 20 mgAlso: Pravastatin 20 mg (Homogeneous)Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group | Drug | Low efficacy statin group (homogeneous) |
Primary outcome
Change of neointimal patterns assessed by 1-year followed OCT
Time frame: at 1 year
Qualitative neointimal pattern measured by OCT such as restenotic tissue structure
2 secondary outcomes
stent coverage and neointimal thickness
Time frame: at 1 year
Major adverse cardiac events
Time frame: at 1 year
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 27 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin 40mg and pravastatin 20 mg in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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 5 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 27 Jul 2016. 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 South Korea. 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.
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?
Change of neointimal patterns assessed by 1-year followed OCT (time frame: at 1 year). 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 27 Jul 2016.