Coronary Artery DiseaseNCT01751295
Statin and Post-interventional Coronary Microcirculation Dysfunction
A study testing Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Aug 2014
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A. Finished informed consent
- B. Stable angina with clinical indication of coronary angiography
- C. Age ≥ 21 year and ≤ 80 year
Who cannot join
- A.Without informed consent
- B.PCI target lesion is not adequate or not indicated for FFR/IMR study
- C.Prior myocardial infarction or interventional procedure for PCI target vessel
- D.Myocardial infarction within 30 days
- E.Usage of statin, current or within 1 month
- F.Prior bypass surgery
Show all 13Show fewer
- G.Impaired renal function (Creatinine > 2.0 mg/dL)
- H.Impaired left ventricular function (ejection fraction < 40%)
- I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN)
- J.Contraindication for long-term antiplatelet agent or statin
- K.Planning or potential of pregnancy
- L.Neoplastic disease without evidence of treatment completion
- M.Impaired general condition
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, 135-710
About this study
Official title: Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.
Read the detailed description
Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.
In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.
- Conditions
- Coronary Artery Disease
- Being tested
- Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI
- 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, pre-treatment 80 mg/day for 4 days before PCIDrug
Also called lipinon
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin | Active comparator | PCI with atorvastatin pre-treatment group Receives: Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI |
| control | No intervention | PCI without atorvastatin pre-treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel
Measured: within 1 year after PCI
Secondary outcomes (3)
Post-procedural troponin I
Measured: within 1 year after PCI
Post-procedural FFR
Measured: within 1 year after PCI
Post-procedural IMR comparison of target vessel with non-target vessel
Measured: within 1 year after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (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.
- More trials run by Samsung Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Ho Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751295
- Sponsor's protocol ID
- 2012-08-052
- Status last verified
- Dec 2012
- First submitted
- 13 Dec 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
- ClinicalTrials.gov ID
- NCT01751295
- Acronym / sponsor ID
- 2012-08-052
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 17 Dec 2012 (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 is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.
Detailed description
Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.
In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin | Active comparator | Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCIPCI with atorvastatin pre-treatment group |
| control | No intervention | –PCI without atorvastatin pre-treatment group |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A. Finished informed consent
- B. Stable angina with clinical indication of coronary angiography
- C. Age ≥ 21 year and ≤ 80 year
Key exclusion criteria (13 listed)
- A.Without informed consent
- B.PCI target lesion is not adequate or not indicated for FFR/IMR study
- C.Prior myocardial infarction or interventional procedure for PCI target vessel
- D.Myocardial infarction within 30 days
- E.Usage of statin, current or within 1 month
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, pre-treatment 80 mg/day for 4 days before PCIAlso: lipinon | Drug | atorvastatin |
Primary outcome
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel
Time frame: within 1 year after PCI
3 secondary outcomes
Post-procedural troponin I
Time frame: within 1 year after PCI
Post-procedural FFR
Time frame: within 1 year after PCI
Post-procedural IMR comparison of target vessel with non-target vessel
Time frame: within 1 year after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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, pre-treatment 80 mg/day for 4 days before PCI in people with Coronary Artery Disease, run by Samsung Medical Center 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 3 inclusion and 13 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 17 Dec 2012. 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?
Results are not available in the source record.
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?
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel (time frame: within 1 year after PCI). 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 17 Dec 2012.