Peking and Rotterdam on Mission to Reduce Coronary Artery Disease

NCT01653119 | Unknown DMC

• 1 other identifier: PUCRP-004
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS

  during 12 months follow-up

Secondary Outcomes (1)

• A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS

  during 30 days follow-up

Other Outcomes (1)

• The proportion of any AST or ALT >3 x ULN or CK >5 x ULN

  during the 1-year follow up period

Study Arms (2)

High loading dose of rosuvastatin

ACTIVE COMPARATOR

rosuvastatin 20mg/d×1w

Drug: Rosuvastatin

Routine rosuvastatin therapy

ACTIVE COMPARATOR

rosuvastatin 10mg/d×1w

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

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

Also known as: Crestor

High loading dose of rosuvastatin; Routine rosuvastatin therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Diabetes Mellitus

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Wei Gao, Master

CONTACT

+8613901366179; dr_gaowei@medmail.com.cn

Wei Zhao

CONTACT

+8618600017812; beate_vv@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 30, 2012

Record last verified: 2012-03

Locations

CN (1)