- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02077257
LDL-C Lowering Efficacy and Safety of Rosuvastatin 20 mg/Day to10 mg/Day in Chinese ACS(Acute Coronary Syndrome) Patients
A 12-Week, Randomized, Open-Label, Multicenter Study Exploring Low-Density Lipoprotein Cholesterol Lowering Efficacy and Safety of Rosuvastatin 20 mg/Day Compared to10 mg/Day in Chinese Patients With Acute Coronary Syndromes
This is a 12-week, randomized, open-label,,multicenter, Phase IV study exploring LDL-C lowering efficacy of Rosuvastatin 20 mg/d compared to 10 mg/day Chinese ACS patients.The Randomized Treatment Period is preceded by a 24hours Screening Period. The study flow chart (Figure 1) depicts the 2 periods which comprise the study. These periods are described as follows:
- Screening Period (Day -1 through Day 1) This period consists of Visits 1 and 2. Subjects entering the Screening Period are required to meet the inclusion criteria. All subjects will be instructed to follow the current TLC(therapeutic lifestyle change)dietary guidelines for the duration of the trial.
- 12-week Randomized Treatment Period (Day 1 through Week 12) This period consists of Visits 2, 3, 4, and 5. Eligible subjects will be randomized at Visit 2 to each treatment group: Rosuvastatin 20 mg orRosuvastatin10 mg. Treatment will be administered once daily for 12 weeks.
A total of 450valid subjects in each of the Rosuvastatin arms are required, in order to test the hypothesis of superiority for comparison of LDL-C levels between Rosuvastatin20 mg and Rosuvastatin10 mg(see Section 6.1 for more details).
The Study visit schedule(Table 2) indicates the number and timing of the planned visits. The visit schedule must be within time window. At the final visit, it is the responsibility of the investigator to ensure the subject is offered an selected appropriate type of lipid-lowering therapy.
Scheduled Visit3,4,5 will have a visit window of ±2 days. Subjects who attend a clinic visit without fasting (at least 12 hours) should be asked to return within 2 days for another clinic visit after fasting for at least 12 hours.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Xubo Shi
- Email: SHIXUBO@VIP.SINA.COM
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Beijing Anzhen Hospital
-
Contact:
- Changsheng Ma, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-80 year old males and non-child-bearing period females.
- Clinical diagnosed with acute coronary syndrome including NSTE-ACS ,MI and STEMI.
- Patients with STEMI((ST segment elevation myocardial infarction) and NSTEMI(non-ST segment elevation myocardial infarction) will be recruited within 48 hours of symptom onset.
- The LDL-C≥70mg/dL one week before randomization.
- The TG<500mg/dL one week before randomization.
- No cholesterol-lowering drugs (including lipid lowering dietary supplements, antioxidants, or food additives) during 4 weeks before randomization.
- Sign the ICF(inform consent form)
Exclusion Criteria:
- Acute pulmonary edema, severe congestive heart failure,
- acute moderate mitral regurgitation, acute ventricular septal perforation,
- severe arrhythmia (ventricular fibrillation, sustained ventricular tachycardia, complete heart block), sepsis, acute pericarditis,
- any evidence of systemic or pulmonary embolus within the preceding 4 weeks.
- Coronary artery bypass graft within the preceding 3 months; percutaneous coronary intervention within the preceding 6 months.
- A history of hypersensitivity of statins and other severe complication.
- child-bearing women
- hypothyroidism,
- active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times ULN(upper limit of normal)
- severe anemia (hemoglobin,hematocrit < 28%),
- Patients with myopathy or serum creatine kinase > 3 times the upper limit of normal not caused by myocardial injury.
- A history of psychiatric disorders
- A history of jejunoileal bypass or gastric bypass surgery
- Currently take steroids therapy
- Currently take phenytoin sodium,phenobarbital,carbamazepine (which may primary efficacy endpoint)
- Diagnosed with malignant within 5 years
- Severe renal function damage (creatinine clearance rate<30 ml/min)
- Concurrent use ciclosporin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Rosuvastatin 20mg
Rosuvastatin 20 mg/d
|
Rosuvastatin 20 mg/d compared to 10 mg/day
|
Other: Rosuvastatin 10mg
Rosuvastatin 10 mg/d
|
Rosuvastatin 20 mg/d compared to 10 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LDL-C absolute value and percent change from baseline
Time Frame: 12 weeks
|
Rosuvastatin 20mg/d ( absolute value and percent change from baseline) compared with that of Rosuvastatin 10mg/d (absolute value and percent change from baseline) in lowering LDL-C averaged over measurements at 12 weeks.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction)
Time Frame: 6 week
|
Efficacy of Rosuvastatin 20 mg/d vs Rosuvastatin 10 mg/don blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction) at Weeks 6
|
6 week
|
blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction)
Time Frame: 12 weeks
|
Efficacy of Rosuvastatin 20 mg/d vs Rosuvastatin 10 mg/don blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction) at Weeks 12
|
12 weeks
|
Percent change from baseline in TC,HDL-C, TG, nonHDL-C (non HDL-C = [TC-HDL-C]), ApoA-I, ApoB, LDL-C/HDL-C, TC/HDL-C, non HDL-C/HDL-C, ApoB/ApoA-I and LDL-C
Time Frame: 6weeks
|
Percent change from baseline in TC(total cholesterol), HDL-C(high density lipid cholesterol), TG(triglyceride), nonHDL-C (non HDL-C = [TC-HDL-C]), ApoA-I(apolipoprotein A ), ApoB(apolipoprotein B ), LDL-C/HDL-C, TC/HDL-C, non HDL-C/HDL-C, ApoB/ApoA-I and LDL-C at Weeks 6 .
|
6weeks
|
Percent change from baseline in TC, HDL-C, TG, nonHDL-C (non HDL-C = [TC-HDL-C]), ApoA-I, ApoB, LDL-C/HDL-C, TC/HDL-C, non HDL-C/HDL-C, ApoB/ApoA-I and LDL-C
Time Frame: 12 weeks
|
Percent change from baseline in TC, HDL-C, TG, nonHDL-C (non HDL-C = [TC-HDL-C]), ApoA-I, ApoB, LDL-C/HDL-C, TC/HDL-C, non HDL-C/HDL-C, ApoB/ApoA-I and LDL-C at week 12
|
12 weeks
|
Percent change from baseline in the level of hsCRP(high-sensitivity C-reactive protein), an inflammatory marker
Time Frame: 6 weeks
|
Percent change from baseline in the level of hsCRP, an inflammatory marker, following 6 weeks
|
6 weeks
|
Percent change from baseline in the level of hsCRP, an inflammatory marker,
Time Frame: 12 weeks
|
Percent change from baseline in the level of hsCRP, an inflammatory marker, following 12 weeks
|
12 weeks
|
incidence and severity of adverse events
Time Frame: 12 weeks
|
12 weeks
|
|
abnormal physical examination findings
Time Frame: 12 weeks
|
12 weeks
|
|
abnormal laboratory values
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dayi Hu, Doctor, Beijing University People's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- ROSE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Coronary Syndrome
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
-
OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
-
Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
-
Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
-
Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
-
University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
-
Deutsches Herzzentrum MuenchenDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)CompletedAcute Coronary Syndrome (ACS)Germany, Italy
-
Northwestern UniversityTerminatedACS - Acute Coronary SyndromeUnited States
Clinical Trials on Rosuvastatin
-
AstraZenecaCompletedDyslipidemia | Kidney DiseaseUnited States, Puerto Rico
-
Yuhan CorporationCompletedHypertension | HyperlipidemiaKorea, Republic of
-
Ottawa Hospital Research InstituteUnknownVenous ThromboembolismCanada, Norway
-
Kobe UniversityCompletedCoronary Artery Disease Progression
-
National Institute of Diabetes and Digestive and...National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
Gachon University Gil Medical CenterDaewoong Pharmaceutical Co. LTD.UnknownCoronary Artery DiseaseKorea, Republic of
-
Alvogen KoreaCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedUnknownHealthyKorea, Republic of
-
Organon and CoCompleted