Acute Coronary SyndromePhase 4ILLEPE-ACSNCT01040936
Intensive Lipid Lowering Treatment in Non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) Patients
A Phase 4 study testing Atorvastatin in people with Acute Coronary Syndrome, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Nov 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- finish informed consent
- age≥18y and under 75y
- diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
- willing to receive the coronary angiography and potential PCI therapy
Who cannot join
- patient was treated by statins before randomization
- stable angina or ST elevation myocardial infarction
- without informed consent
- abnormal liver function before randomization, (AST，ALT≥3ULN)
- active hepatitis or muscular disease
- impaired renal function with serum creatinine level > 3mg/dl
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- impaired left ventricular systolic function with LVEF< 30%
- participating in other studies
- non-PCI treated patients after coronary angiography will be washed out
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Dept. of Cardiology
Shanghai, Shanghai Municipality, 200025
Xin Chen, MD, +862164370045 ext. 665215, rjchenxin@yahoo.com.cn
About this study
Official title: Intensive Lipid Lowering Treatment in Patients With Non-ST-elevation ACS Undergoing Percutaneous Coronary Intervention
PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Atorvastatin
- Keywords
- acute coronary syndrome, intervention, outcome, patients diagnosed ad Non-ST elevation ACS, patients received PCI therapy
- 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.
AtorvastatinDrug
patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year
AtorvastatinDrug
patients admitted with Non-ST elevation ACS will be loaded with atorvastatin 80mg once, continued with 40mg/d for 30d, then change to 20mg/d, as a regular dose in China
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | patients will be treated by atorvastation 20mg/d after randomization, and continued for one year. Receives: Drug: Atorvastatin |
| intensive group | Experimental | patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization.
Measured: one year
Secondary outcomes (3)
rate of peri-procedural myocardial infarction
Measured: 30days
MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization
Measured: 30 days
changes of left ventricular function at 30d after randomization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionOct 2011 (estimated)
- Study completionNov 2011 (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.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Wei Feng Shen, MD, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040936
- Sponsor's protocol ID
- RJH-091228
- Other IDs
- RJH-2009
- Acronym
- ILLEPE-ACS
- Status last verified
- Feb 2011
- First submitted
- 29 Dec 2009
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Lipid Lowering Treatment in Patients With Non-ST-elevation ACS Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01040936
- Acronym / sponsor ID
- ILLEPE-ACS / RJH-091228
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, intervention, outcome, patients diagnosed ad Non-ST elevation ACS, patients received PCI therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 30 Dec 2009 (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.
PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Drug: Atorvastatinpatients will be treated by atorvastation 20mg/d after randomization, and continued for one year. |
| intensive group | Experimental | Drug: Atorvastatinpatient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- finish informed consent
- age≥18y and under 75y
- diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
- willing to receive the coronary angiography and potential PCI therapy
Key exclusion criteria (9 listed)
- patient was treated by statins before randomization
- stable angina or ST elevation myocardial infarction
- without informed consent
- abnormal liver function before randomization, (AST，ALT≥3ULN)
- active hepatitis or muscular disease
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 |
|---|---|---|
| Atorvastatinpatients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year | Drug | conventional group |
| Atorvastatinpatients admitted with Non-ST elevation ACS will be loaded with atorvastatin 80mg once, continued with 40mg/d for 30d, then change to 20mg/d, as a regular dose in China | Drug | intensive group |
Primary outcome
The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization.
Time frame: one year
3 secondary outcomes
rate of peri-procedural myocardial infarction
Time frame: 30days
MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization
Time frame: 30 days
changes of left ventricular function at 30d after randomization
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
Wei Feng Shen, MD, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
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 Atorvastatin in people with Acute Coronary Syndrome, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 4 inclusion and 9 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 15 Jun 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 China. 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 Qi Zhang, MD (+862164370045 ext. 665380, zhangqnh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization. (time frame: one 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 15 Jun 2011.