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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin 20mg | Other | Rosuvastatin 20 mg/d |
|
| Rosuvastatin 10mg | Other | Rosuvastatin 10 mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin 20 mg/d compared to 10 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| blood lipid goal achievement rate(LDL-C <70 mg/dl or 50% reduction) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xubo Shi | Contact | SHIXUBO@VIP.SINA.COM |
| Name | Affiliation | Role |
|---|---|---|
| Dayi Hu, Doctor | Beijing university People's hospital | Principal Investigator |
| Changsheng Ma, Doctor | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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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 | 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 | 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 | 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, | Percent change from baseline in the level of hsCRP, an inflammatory marker, following 12 weeks | 12 weeks |
| incidence and severity of adverse events | 12 weeks |
| abnormal physical examination findings | 12 weeks |
| abnormal laboratory values | 12 weeks |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |