Acute Coronary SyndromeRESIST-ACSNCT01491256
Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading
A study testing Pre-procedural High dose atorvastatin loading and No pre-procedural high-dose atorvastatin loading in people with Acute Coronary Syndrome, run by The Korean Society of Circulation at 1 site in South Korea.
Trial summary
Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Pre-procedural High dose atorvastatin loading and No pre-procedural high-dose atorvastatin loading
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Feb 2012
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention
Who cannot join
- ST elevation myocardial infarction
- Cardiogenic shock
- Congestive heart failure with pulmonary edema
- Severe left ventricular dysfunction (LVEF < 30%)
- History of previous coronary revascularization therapy
- chronic total coronary occlusion
Show all 16Show fewer
- 3 vessel disease
- Target lesion at distal segments or branches
- Ostial lesion
- Excessive coronary calcification or thrombi
- Elevated transaminase
- Renal dysfunction (serum creatinine > 2.0mg/dL
- History of myopathy
- Contra-indication to anti-platelet therapy
- Not indicated for percutaneous coronary intervention
- Other co-morbidity with life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangwon National University Hospital
Chuncheon, 200-722
Bong-Ki Lee, MD, PhD, +82-10-6373-9290, nicedr@nate.com
Bon-Kwon Koo, MD, PhD
About this study
Official title: Randomized Comparison Multicenter Trial of High Dose Atorvastatin Pre-treatment on Microcirculatory Dysfunction After Drug-ElutIng Stent Implantation in Patients With Acute Coronary Syndrome
Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.
Read the detailed description
One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12~24 hours after PCI.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Pre-procedural High dose atorvastatin loading, No pre-procedural high-dose atorvastatin loading
- Keywords
- Index of microcirculatory resistance, atorvastatin, drug-eluting stent, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-procedural High dose atorvastatin loadingDrug
Also called Lipitor (Pfizer)
Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention
No pre-procedural high-dose atorvastatin loadingDrug
Also called Lipitor (Pfizer)
atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| High dose Atorvastatin | Active comparator | Arm of pre-procedural high dose atorvastatin loading Receives: Drug: Pre-procedural High dose atorvastatin loading |
| Control | Placebo comparator | No pre-procedural high dose atorvastatin loading Receives: Drug: No pre-procedural high-dose atorvastatin loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of microcirculatory resistance (IMR)
After stent implantation and adjunctive balloon dilatation, final angiogram will be taken. If the final angiogram shows successful results, IMR will be measured and the procedure will be finished.
Measured: Immediately after percutaneous coronary intervention
Secondary outcomes (1)
Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure
Measured: 1 year after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startFeb 2010
- Primary completionNov 2011
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Korean Society of Circulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bong-Ki Lee, The Korean Society of Circulation
- Investigators
- Bong-Ki Lee, MD, PhD, Principal investigator, KangWon National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491256
- Sponsor's protocol ID
- RESIST-ACS
- Acronym
- RESIST-ACS
- Status last verified
- Dec 2011
- First submitted
- 1 Dec 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Multicenter Trial of High Dose Atorvastatin Pre-treatment on Microcirculatory Dysfunction After Drug-ElutIng Stent Implantation in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01491256
- Acronym / sponsor ID
- RESIST-ACS / RESIST-ACS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Index of microcirculatory resistance, atorvastatin, drug-eluting stent, acute coronary syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Korean Society of CirculationUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (estimated)
- First posted
- 13 Dec 2011 (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.
Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.
Detailed description
One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12~24 hours after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Atorvastatin | Active comparator | Drug: Pre-procedural High dose atorvastatin loadingArm of pre-procedural high dose atorvastatin loading |
| Control | Placebo comparator | Drug: No pre-procedural high-dose atorvastatin loadingNo pre-procedural high dose atorvastatin loading |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention
Key exclusion criteria (16 listed)
- ST elevation myocardial infarction
- Cardiogenic shock
- Congestive heart failure with pulmonary edema
- Severe left ventricular dysfunction (LVEF < 30%)
- History of previous coronary revascularization therapy
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 |
|---|---|---|
| Pre-procedural High dose atorvastatin loadingAlso: Lipitor (Pfizer)Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention | Drug | High dose Atorvastatin |
| No pre-procedural high-dose atorvastatin loadingAlso: Lipitor (Pfizer)atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention | Drug | Control |
Primary outcome
Index of microcirculatory resistance (IMR)
Time frame: Immediately after percutaneous coronary intervention
After stent implantation and adjunctive balloon dilatation, final angiogram will be taken. If the final angiogram shows successful results, IMR will be measured and the procedure will be finished.
1 secondary outcome
Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure
Time frame: 1 year after index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
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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.
Bong-Ki Lee, MD, PhD principal investigator
KangWon National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-procedural High dose atorvastatin loading and No pre-procedural high-dose atorvastatin loading in people with Acute Coronary Syndrome, run by The Korean Society of Circulation 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 1 inclusion and 16 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 13 Dec 2011. 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. Some participants in this study may receive a placebo. 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?
Contact Bong-Ki Lee, MD, PhD (+82-10-6373-9290, nicedr@nate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of microcirculatory resistance (IMR) (time frame: Immediately after percutaneous coronary intervention). 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 13 Dec 2011.