Angioplasty, Transluminal, Percutaneous CoronaryNCT00610870
Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention
A study testing atorvastatin in people with Angioplasty, Transluminal, Percutaneous Coronary, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study to determine whether statin pretreatment decrease myocardial infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Aug 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST segment elevation more than 1 mm in two or more contiguous leads or presumably a new onset left bundle branch blockage
Who cannot join
- Cardiogenic shock
- History of myocardial infarction
- Chronic liver disease
- Previous or current statin use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
The purpose of this study to determine whether statin pretreatment decrease myocardial infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.
- Being tested
- atorvastatin
- Keywords
- Myocardial infarct size, Atorvastatin, SPECT, Hydroxymethylglutaryl-CoA Reductase Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
atorvastatin 80mg/day before primary coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Atorvastatin group Receives: Drug: atorvastatin |
| 2 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size by SPECT
Measured: between 5 and 14 days after acute myocardial infarction
Secondary outcomes (4)
Myocardial infarct size measured by contrast-enhanced MRI
Measured: within 14 days after acute myocardial infarction
Myocardial blush grade after the procedure
Measured: immediate after procedure
complete ST resolution
Measured: at 60 minutes after the procedure
major adverse cardiac events related to left ventricular dysfunction (death, new-onset sustained hypotension or heart failure, and hospital readmission for left ventricular dysfunction)
Measured: at 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioplasty, Transluminal, Percutaneous CoronaryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hyeon-Cheol Gwon, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610870
- Sponsor's protocol ID
- 2007-04-049
- Status last verified
- Mar 2011
- First submitted
- 27 Jan 2008
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00610870
- Acronym / sponsor ID
- 2007-04-049
- Keywords
- Myocardial infarct size, Atorvastatin, SPECT, Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Feb 2008 (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 to determine whether statin pretreatment decrease myocardial infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: atorvastatinAtorvastatin group |
| 2 | No intervention | –Control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST segment elevation more than 1 mm in two or more contiguous leads or presumably a new onset left bundle branch blockage
Key exclusion criteria (4 listed)
- Cardiogenic shock
- History of myocardial infarction
- Chronic liver disease
- Previous or current statin use
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 |
|---|---|---|
| atorvastatinatorvastatin 80mg/day before primary coronary intervention | Drug | 1 |
Primary outcome
Myocardial infarct size by SPECT
Time frame: between 5 and 14 days after acute myocardial infarction
4 secondary outcomes
Myocardial infarct size measured by contrast-enhanced MRI
Time frame: within 14 days after acute myocardial infarction
Myocardial blush grade after the procedure
Time frame: immediate after procedure
complete ST resolution
Time frame: at 60 minutes after the procedure
major adverse cardiac events related to left ventricular dysfunction (death, new-onset sustained hypotension or heart failure, and hospital readmission for left ventricular dysfunction)
Time frame: at 6 months after the procedure
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 3 Mar 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.
Hyeon-Cheol Gwon, MD, PhD principal investigator
Samsung Medical Center
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 in people with Angioplasty, Transluminal, Percutaneous Coronary, 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 2 inclusion and 4 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 3 Mar 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. 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?
Myocardial infarct size by SPECT (time frame: between 5 and 14 days after acute myocardial infarction). 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 3 Mar 2011.