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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Positive Trial Group
• Treatments: Pravastatin; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

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

1. Patients giving voluntary written consent to participate in the study

2. Male or female patients 50 years of age or older (at informed consent)

3. Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)

4. Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)

5. Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)

6. 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:

1. Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent

2. Patients judged to have familial hypercholesterolemia

3. Patients with a serum triglyceride level of ≥400 mg/dL

4. Patients with a history of myocardial infarction

5. Patients with a history of coronary revascularization (PCI or CABG)

6. Patients with a history of treatment of unstable angina

7. Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)

8. Heart failure patients

9. Patients with a history of hypersensitivity to statins

10. Patients with a history of drug-induced myopathy

11. Patients with poorly controlled arrhythmia

12. Patients with severe liver or kidney disease

13. Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan

14. Patients who are or may be pregnant

15. Patients judged by the investigators to be ineligible for participation in the study for any other reason