Non-ST-elevation Acute Coronary SyndromesPhase 4NCT02284503
Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With Non ST-segment Elevated Acute Coronary Syndrome(NSTE-ACS)
A Phase 4 study testing Rosuvastatin in people with Non-ST-elevation Acute Coronary Syndromes, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-ST-elevation Acute Coronary Syndromes
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Jun 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 year old males and non-child-bearing period females.
- Clinical diagnosed with NSTE-ACS, including unstable angina or non-ST-segment elevation myocardial infarction(NSTEMI).
- For unstable angina, the diagnose should meet all below:
- Clinical onset features: angina for at least 20 min when resting; initial onset angina pectoris(new onset within one month) manifests spontaneous angina or labor angina (CCS grade II or III); Symptoms of original stable angina pectoris aggravate in one month and at least achieve CCS grade III (accelerated angina pectoris); angina onset within one month after MI.
- ECG: At least twice in one month: ST depression or elevation >0.1millivolt (mv) or T-wave inversion ≥0.2 mv in 2 or more contiguous electrocardiographic leads when onset and the ST-T changes recovered after remission of chest pain. Myocardial damage marker do not elevate or reach the MI diagnostic level.
- For NSTEMI, the diagnose should meet all below ischemia symptoms(ischemic chest pain lasting more than 30 min and cannot relief significantly by sub-lingual NTG) ECG change: new ST-T dynamic development (new or transient ST depression ≥0.1mv or T-wave inversion≥0.2mv).
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- Myocardial damage marker level is normal or elevated to the MI diagnostic level.
- Received early (within 48 h) Percutaneous Coronary Intervention(PCI).
- Should be statin- naïve(last 3 months).
- Only receive drug-eluting stents.
- Sign the Informed Consent Form(ICF)
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- Diagnosis as STEMI;
- NSTE-ACS with high-risk features warranting emergency coronary angiography;
- Receive only medical therapy or Coronary Artery Bypass Graft(CABG)
- Active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times upper limit of normal(ULN);
- Left ventricular ejection fraction<30%;
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- Previous or current treatment with statins;
- Patients with myopathy or serum creatine kinase > 5 times the upper limit of normal not caused by myocardial injury;
- Severe renal function damage (creatinine clearance rate<30 ml/min);
- Severe anemia (haemoglobin< 6g/L);
- Diagnosed with malignancy within 5 years;
- Concurrent use ciclosporin；
- Investigator evaluated as not appropriate for statins.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Yinman Wang, Master, +86 21 64041990 ext. 2521, wang.yinman@zs-hospital.sh.cn
Junbo Ge, MD
About this study
Official title: A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS
This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.
Read the detailed description
Non ST-segment elevated acute coronary syndrome(NSTE-ACS) is increasing rapidly, and is more frequent than ST-segment elevated acute coronary syndrome (STE-ACS) now. NSTE-ACS patients sent to early PCI procedure is large and increasing rapidly in China.Quite a few trials have focused on high loading dose statin before PCI to improve cardiovascular outcomes in ACS. In Asian, high loading dose statin therapy showed different outcome. Rosuvastatin (RSV) is one of the most potent statins.Nowadays, quite a few experts think ACS patients undergoing PCI not only need loading dose statin, but also post PCI intensive statin treatment is rather important. Chinese consensus and western guidelines recommend intensive statin treatment in these patients. However, Chinese consensus referred to the western study as there's no relevant intensive statin treatment peri-PCI study in China until now.
Thus this study is designed to explore the efficacy of intensive statin treatment peri-PCI (early loading dose-RSV 40 mg or 20mg before PCI and subsequent 20mg post PCI) in periprocedural myocardial injury and 30 days MACE reduction in Chinese NSTE-ACS patients and explore efficacy of 30-day RSV 20 mg post-PCI treatment in lipid profile, inflammatory factors compared with baseline.
- Being tested
- Rosuvastatin
- Keywords
- MI reduction, intensive statin treatment, NSTE-ACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Rosuvastatin Calcium Tablets
The subjects will receive intensive Rosuvastatin before and after PCI
| Study group | Role | What they receive |
|---|---|---|
| 40mg Rosuvastatin group | Experimental | The subjects in this group will receive Rosuvastatin 40mg within 12±2h before PCI, follow 20mg post PCI for 30days. Receives: Drug: Rosuvastatin |
| 20mg Rosuvastatin group | Experimental | The subjects in this group will receive Rosuvastatin 20mg within 12±2h before PCI, follow 20mg post PCI for 30days. Receives: Drug: Rosuvastatin |
| no statin group | Experimental | The subjects in this group will not receive Rosuvastatin before PCI, follow 10mg post PCI for 30days. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial injury reduction
Myocardial injury assessed by creatine kinase-MB. (CK-MB) elevation, defined as a post-procedural elevation of CK-MB values >3×99th percentile Upper Reference Limit (URL) in patients with normal baseline values >99th percentile URL or a rise of CK-MB values>20% if the baseline values are elevated and are stable or falling; or assessed by cTn elevation, defined as a post-procedural elevation of cardiac troponin (cTn) values >5×99th percentile URL in patients with normal baseline values >99th percentile URL or a rise of cTn values>20% if the baseline values are elevated and are stable or falling.
Measured: 30 days
Secondary outcomes (3)
MACE reduction
Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke
Measured: 30 days
the change of lipid
the change of lipid marker, including Low-density lipoprotein cholesterol(LDL-C), total cholesterol(TC), High-density lipoprotein cholesterol(HDL-C), triglyceride(TG), non-HDL-C, between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days.
Measured: 30 days
the change of hsCRP
The change of inflammatory marker High sensitivity C-reactive protein(hsCRP) between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days.
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 posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-ST-elevation Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- None (open label)
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284503
- Sponsor's protocol ID
- ISSCRES0169
- Status last verified
- Nov 2014
- First submitted
- 30 Oct 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.
PubMed 20558366Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.
PubMed 15277322Winchester DE, Wen X, Xie L, Bavry AA. Evidence of pre-procedural statin therapy a meta-analysis of randomized trials. J Am Coll Cardiol. 2010 Sep 28;56(14):1099-109. doi: 10.1016/j.jacc.2010.04.023. Epub 2010 Aug 31.
PubMed 20825761Yun KH, Oh SK, Rhee SJ, Yoo NJ, Kim NH, Jeong JW. 12-month follow-up results of high dose rosuvastatin loading before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2011 Jan 7;146(1):68-72. doi: 10.1016/j.ijcard.2010.04.052. Epub 2010 May 14.
PubMed 20471117Yun KH, Jeong MH, Oh SK, Rhee SJ, Park EM, Lee EM, Yoo NJ, Kim NH, Ahn YK, Jeong JW. The beneficial effect of high loading dose of rosuvastatin before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2009 Nov 12;137(3):246-51. doi: 10.1016/j.ijcard.2008.06.055. Epub 2008 Aug 15.
PubMed 18706705Gao yuan et al. Comparison of Effects of Loading Dose Rosuvastatin VERSUS Atorvastatin Therapy in Non-ST Segment Elevation Acute Coronary Syndrome Patients. Journal of China Medical University. 2013; 42:235-239.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS
- ClinicalTrials.gov ID
- NCT02284503
- Acronym / sponsor ID
- ISSCRES0169
- Keywords
- MI reduction, intensive statin treatment, NSTE-ACS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 6 Nov 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 is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.
Detailed description
Non ST-segment elevated acute coronary syndrome(NSTE-ACS) is increasing rapidly, and is more frequent than ST-segment elevated acute coronary syndrome (STE-ACS) now. NSTE-ACS patients sent to early PCI procedure is large and increasing rapidly in China.Quite a few trials have focused on high loading dose statin before PCI to improve cardiovascular outcomes in ACS. In Asian, high loading dose statin therapy showed different outcome. Rosuvastatin (RSV) is one of the most potent statins.Nowadays, quite a few experts think ACS patients undergoing PCI not only need loading dose statin, but also post PCI intensive statin treatment is rather important. Chinese consensus and western guidelines recommend intensive statin treatment in these patients. However, Chinese consensus referred to the western study as there's no relevant intensive statin treatment peri-PCI study in China until now.
Thus this study is designed to explore the efficacy of intensive statin treatment peri-PCI (early loading dose-RSV 40 mg or 20mg before PCI and subsequent 20mg post PCI) in periprocedural myocardial injury and 30 days MACE reduction in Chinese NSTE-ACS patients and explore efficacy of 30-day RSV 20 mg post-PCI treatment in lipid profile, inflammatory factors compared with baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40mg Rosuvastatin group | Experimental | Drug: RosuvastatinThe subjects in this group will receive Rosuvastatin 40mg within 12±2h before PCI, follow 20mg post PCI for 30days. |
| 20mg Rosuvastatin group | Experimental | Drug: RosuvastatinThe subjects in this group will receive Rosuvastatin 20mg within 12±2h before PCI, follow 20mg post PCI for 30days. |
| no statin group | Experimental | Drug: RosuvastatinThe subjects in this group will not receive Rosuvastatin before PCI, follow 10mg post PCI for 30days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18-80 year old males and non-child-bearing period females.
- Clinical diagnosed with NSTE-ACS, including unstable angina or non-ST-segment elevation myocardial infarction(NSTEMI).
- Clinical onset features: angina for at least 20 min when resting; initial onset angina pectoris(new onset within one month) manifests spontaneous angina or labor angina (CCS grade II or III); Symptoms of original stable angina pectoris aggravate in one month and at least achieve CCS grade III (accelerated angina pectoris); angina onset within one month after MI.
- ECG: At least twice in one month: ST depression or elevation >0.1millivolt (mv) or T-wave inversion ≥0.2 mv in 2 or more contiguous electrocardiographic leads when onset and the ST-T changes recovered after remission of chest pain. Myocardial damage marker do not elevate or reach the MI diagnostic level.
- Myocardial damage marker level is normal or elevated to the MI diagnostic level.
Key exclusion criteria (13 listed)
- Diagnosis as STEMI;
- NSTE-ACS with high-risk features warranting emergency coronary angiography;
- Receive only medical therapy or Coronary Artery Bypass Graft(CABG)
- Active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times upper limit of normal(ULN);
- Left ventricular ejection fraction<30%;
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 |
|---|---|---|
| RosuvastatinAlso: Rosuvastatin Calcium TabletsThe subjects will receive intensive Rosuvastatin before and after PCI | Drug | 20mg Rosuvastatin group, 40mg Rosuvastatin group, no statin group |
Primary outcome
myocardial injury reduction
Time frame: 30 days
Myocardial injury assessed by creatine kinase-MB. (CK-MB) elevation, defined as a post-procedural elevation of CK-MB values >3×99th percentile Upper Reference Limit (URL) in patients with normal baseline values >99th percentile URL or a rise of CK-MB values>20% if the baseline values are elevated and are stable or falling; or assessed by cTn elevation, defined as a post-procedural elevation of cardiac troponin (cTn) values >5×99th percentile URL in patients with normal baseline values >99th percentile URL or a rise of cTn values>20% if the baseline values are elevated and are stable or falling.
3 secondary outcomes
MACE reduction
Time frame: 30 days
the change of lipid
Time frame: 30 days
the change of hsCRP
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 6 Nov 2014.
- Results publication: PubMed 20558366Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.
- Results publication: PubMed 15277322Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.
- Results publication: PubMed 20825761Winchester DE, Wen X, Xie L, Bavry AA. Evidence of pre-procedural statin therapy a meta-analysis of randomized trials. J Am Coll Cardiol. 2010 Sep 28;56(14):1099-109. doi: 10.1016/j.jacc.2010.04.023. Epub 2010 Aug 31.
- Results publication: PubMed 20471117Yun KH, Oh SK, Rhee SJ, Yoo NJ, Kim NH, Jeong JW. 12-month follow-up results of high dose rosuvastatin loading before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2011 Jan 7;146(1):68-72. doi: 10.1016/j.ijcard.2010.04.052. Epub 2010 May 14.
- Results publication: PubMed 18706705Yun KH, Jeong MH, Oh SK, Rhee SJ, Park EM, Lee EM, Yoo NJ, Kim NH, Ahn YK, Jeong JW. The beneficial effect of high loading dose of rosuvastatin before percutaneous coronary intervention in patients with acute coronary syndrome. Int J Cardiol. 2009 Nov 12;137(3):246-51. doi: 10.1016/j.ijcard.2008.06.055. Epub 2008 Aug 15.
- Results publicationGao yuan et al. Comparison of Effects of Loading Dose Rosuvastatin VERSUS Atorvastatin Therapy in Non-ST Segment Elevation Acute Coronary Syndrome Patients. Journal of China Medical University. 2013; 42:235-239.
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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.
Junbo Ge, M.D. principal investigator
Fudan University
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 Rosuvastatin in people with Non-ST-elevation Acute Coronary Syndromes, run by Shanghai Zhongshan Hospital 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 11 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 6 Nov 2014. 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 Yinman Wang, Master (+86 21 64041990 ext. 2521, wang.yinman@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial injury reduction (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284503, which also lists 6 linked publications.
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 6 Nov 2014.