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Acute Coronary SyndromePhase 4NCT02077257

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

A Phase 4 study testing Rosuvastatin in people with Acute Coronary Syndrome, run by Committee of Cardio-Cerebral-Vascular Diseases of GSC at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,060 participants
Where
1 siteChina
Study dates
Mar 2014to May 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Xubo Shi contact

SHIXUBO@VIP.SINA.COM

China1 site, 1 recruiting

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality

    Changsheng Ma, PhD

    Recruiting

Other trials in China

About this study

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

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.
Read more

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.

Being tested
Rosuvastatin
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02077257
Study groupRoleWhat they receive
Rosuvastatin 20mgOtherRosuvastatin 20 mg/d
Receives: Drug: Rosuvastatin
Rosuvastatin 10mgOtherRosuvastatin 10 mg/d
Receives: Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (9)

  1. 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

    Measured: 6 week

  2. 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

    Measured: 12 weeks

  3. 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 .

    Measured: 6weeks

  4. 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

    Measured: 12 weeks

  5. 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

    Measured: 6 weeks

  6. 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

    Measured: 12 weeks

  7. incidence and severity of adverse events

    Measured: 12 weeks

  8. abnormal physical examination findings

    Measured: 12 weeks

  9. abnormal laboratory values

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,060 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077257
Sponsor's protocol ID
ROSE
Status last verified
Nov 2014
First submitted
27 Feb 2014
Last updated
7 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosuvastatin in people with Acute Coronary Syndrome, run by Committee of Cardio-Cerebral-Vascular Diseases of GSC at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xubo Shi (SHIXUBO@VIP.SINA.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C absolute value and percent change from baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014.

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