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

NCT02077257 | Unknown Phase 4

• 1 other identifier: ROSE
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

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:

1. 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. 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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

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

  6 week

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

  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

  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

  12 weeks

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

  6 weeks

Study Arms (2)

Rosuvastatin 20mg

OTHER

Rosuvastatin 20 mg/d

Drug: Rosuvastatin

Rosuvastatin 10mg

OTHER

Rosuvastatin 10 mg/d

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Rosuvastatin 20 mg/d compared to 10 mg/day

Rosuvastatin 10mg; Rosuvastatin 20mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Committee of Cardio-Cerebral-Vascular Diseases of GSC: lead
• AstraZeneca: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dayi Hu, Doctor

  Beijing university People's hospital

  PRINCIPAL INVESTIGATOR

• Changsheng Ma, Doctor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xubo Shi

CONTACT

SHIXUBO@VIP.SINA.COM

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

CN (1)