LDL-C Lowering Efficacy and Safety of Rosuvastatin 20 mg/Day to10 mg/Day in Chinese ACS(Acute Coronary Syndrome) Patients

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02077257
• Other study ID #: ROSE
• Status: Recruiting
• Phase: Phase 4
• First received: February 27, 2014
• Last updated: November 6, 2014
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2014
• Source: Committee of Cardio-Cerebral-Vascular Diseases of GSC
• Contact: Xubo Shi
• Email: SHIXUBO[@]VIP.SINA.COM
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1060
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 20 mg/d compared to 10 mg/day

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Committee of Cardio-Cerebral-Vascular Diseases of GSC	AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C absolute value and percent change from baseline	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	No
Secondary	blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction)	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	No
Secondary	blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction)	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	No
Secondary	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	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	No
Secondary	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	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	No
Secondary	Percent change from baseline in the level of hsCRP(high-sensitivity C-reactive protein), an inflammatory marker	Percent change from baseline in the level of hsCRP, an inflammatory marker, following 6 weeks	6 weeks	No
Secondary	Percent change from baseline in the level of hsCRP, an inflammatory marker,	Percent change from baseline in the level of hsCRP, an inflammatory marker, following 12 weeks	12 weeks	No
Secondary	incidence and severity of adverse events		12 weeks	Yes
Secondary	abnormal physical examination findings		12 weeks	Yes
Secondary	abnormal laboratory values		12 weeks	Yes