Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

NCT ID: NCT01653119

Last Updated: 2012-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin on recurrent events in patients with established DM who is admitted for an ACS.

Conditions

Acute Coronary Syndrome; Diabetes Mellitus

Keywords

Acute coronary syndrome; Diabetes mellitus; Statins; High loading dose; Recurrent events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High loading dose of rosuvastatin

rosuvastatin 20mg/d×1w

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

Both of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year.

Routine rosuvastatin therapy

rosuvastatin 10mg/d×1w

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

Both of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year.

Interventions

Rosuvastatin

Both of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year.

Intervention Type: DRUG

Other Intervention Names

Crestor

Eligibility Criteria

Inclusion Criteria

• • Men or women ≥40 years of age admitted with a clinical diagnosis of ACS. The diagnosis should be based on the combination of typical ischemic chest complaints and objective evidence of myocardial ischemia or myocardial necrosis as demonstrated by the electrocardiogram (ECG) or elevated cardiac markers, as follows:
• Typical ischemic chest pain, lasting 10 minutes or more, within the preceding 24 hours, AND either
• ECG changes indicative of myocardial ischemia within 24 hours after the onset of chest pain (ECG showing persistent or non-persistent ST-segment elevation >1.0 mm in two or more contiguous leads or dynamic ST-segment depression >1.0 mm in two or more contiguous leads) or
• Elevated biomarkers of myocardial necrosis within 24 hours after the onset of chest pain (i.e. CK-MB >1 times the upper limit of normal of the local laboratory, or Troponin-T >0.1 ng/ml.

• A diagnosis of DM type II prior to the index ACS
• Written informed consent

Exclusion Criteria

• • Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension).

• Severely-impaired left ventricular function (ejection fraction <30%) or end-stage congestive heart failure NYHA-class III or IV (in order to avoid lost-to-follow-up due to non-acute coronary syndrome events).
• Severe chronic kidney disease with measured or calculated glomerular filtration rate (Cockgroft-Gault or MDRD4 (Modification of Diet in Renal Disease) formula) of <30 ml/min/1.73m2, or renal dialysis.
• Co-existent condition associated with a life-expectancy <12 months, or otherwise unlikely to appear at all scheduled follow-up visits.
• Known serious or hypersensitivity reactions to HMG-CoA reductase inhibitors.
• Triglyceride (TG) level ≥500 mg/dL (5.65 mmol/L) at screening, because patients with very high triglyceride levels warrant treatment with agents that may increase the risk of side effects associated with statin drugs.
• Active liver disease or hepatic dysfunction, as determined by alanine aminotransferase (ALT [SGPT]) >3 x ULN or bilirubin levels >1.5 x ULN at screening.
• Myopathy.
• Not using effective contraceptive methods.
• Participation in any investigational drug study less than 30 days prior to enrolment.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Gao

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Gao, Master

Role: CONTACT

Phone: +8613901366179

Email: dr_gaowei@medmail.com.cn

Wei Zhao

Role: CONTACT

Phone: +8618600017812

Email: beate_vv@bjmu.edu.cn

Facility Contacts

Wei Gao, Master

Role: primary

Wei Zhao, Doctor

Role: backup

Other Identifiers

PUCRP-004

Identifier Type: -

Identifier Source: org_study_id