Trial | NCT01173939  Report issue

Title

Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments
Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    10000
The study is being conducted to compare the effect of standard treatment (target LDL-C level: <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.
Study Started
Jul 31
2010
Primary Completion
Jun 30
2014
Anticipated
Last Update
Jun 01
2011
Estimate

Drug Pravastatin

5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)

Drug Rosuvastatin

5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)

Active comparator: Standard Pravastatin Group Active Comparator

Intensive Rosuvastatin Group Active Comparator

Criteria 

Inclusion Criteria:

Patients meeting the following inclusion criteria will be included in the study:

Patients giving voluntary written consent to participate in the study
Male or female patients 50 years of age or older (at informed consent)
Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)

Patients with two or more of the following risk factors

Male
65 years of age or older
Smoker
L/H ratio: ≥3.0 •HbA1c level: ≥8.0%
Left ventricular hypertrophy
First- or second-degree family history of MACE
Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (<60 mL/min/1.73 m2)

Exclusion Criteria:

Patients meeting the following criteria will be excluded from the study:

Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
Patients judged to have familial hypercholesterolemia
Patients with a serum triglyceride level of ≥400 mg/dL
Patients with a history of myocardial infarction
Patients with a history of coronary revascularization (PCI or CABG)
Patients with a history of treatment of unstable angina
Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
Heart failure patients
Patients with a history of hypersensitivity to statins
Patients with a history of drug-induced myopathy
Patients with poorly controlled arrhythmia
Patients with severe liver or kidney disease
Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
Patients who are or may be pregnant
Patients judged by the investigators to be ineligible for participation in the study for any other reason
No Results Posted