Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and... | NCT01173939 | Trialant

Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and... | NCT01173939 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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