Know Cancer

or
forgot password

Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension


N/A
50 Years
N/A
Not Enrolling
Both
Hypercholesterolemia, Type 2 Diabetes, Hypertension

Thank you

Trial Information

Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event

Outcome Time Frame:

At baseline

Safety Issue:

No

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

0035

NCT ID:

NCT01173939

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Hypercholesterolemia
  • Type 2 Diabetes
  • Hypertension
  • Hypercholesterolemia with concomitant type 2 diabetes and hypertension
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Hypercholesterolemia
  • Hypertension

Name

Location