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

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Rosuvastatin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Rosuvastatin 20mg

Rosuvastatin 10mg

Arm Description

Rosuvastatin 20 mg/d

Rosuvastatin 10 mg/d

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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 .

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

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

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

incidence and severity of adverse events

abnormal physical examination findings

abnormal laboratory values

Full Information

NCT ID

NCT02077257

First Posted

February 27, 2014

Last Updated

November 6, 2014

Sponsor

Committee of Cardio-Cerebral-Vascular Diseases of GSC

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02077257

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Committee of Cardio-Cerebral-Vascular Diseases of GSC

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1060 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rosuvastatin 20mg

Arm Type

Other

Arm Description

Rosuvastatin 20 mg/d

Arm Title

Rosuvastatin 10mg

Arm Type

Other

Arm Description

Rosuvastatin 10 mg/d

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Intervention Description

Rosuvastatin 20 mg/d compared to 10 mg/day

Primary Outcome Measure Information:

Title

LDL-C absolute value and percent change from baseline

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction)

Description

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

Time Frame

6 week

Title

blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction)

Description

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

Time Frame

12 weeks

Title

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

Description

Time Frame

6weeks

Title

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

Description

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

Time Frame

12 weeks

Title

Percent change from baseline in the level of hsCRP(high-sensitivity C-reactive protein), an inflammatory marker

Description

Percent change from baseline in the level of hsCRP, an inflammatory marker, following 6 weeks

Time Frame

6 weeks

Title

Percent change from baseline in the level of hsCRP, an inflammatory marker,

Description

Percent change from baseline in the level of hsCRP, an inflammatory marker, following 12 weeks

Time Frame

12 weeks

Title

incidence and severity of adverse events

Time Frame

12 weeks

Title

abnormal physical examination findings

Time Frame

12 weeks

Title

abnormal laboratory values

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xubo Shi

SHIXUBO@VIP.SINA.COM

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dayi Hu, Doctor

Organizational Affiliation

Beijing university People's hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Changsheng Ma, Doctor

Organizational Affiliation

Beijing Anzhen Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Anzhen Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Changsheng Ma, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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