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

Positive Trial Group

Status: Terminated

Conditions: Hypertension; Hypercholesterolemia; Type 2 Diabetes

Treatments: Drug: Pravastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01173939

0035

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 2 patient groups

Active comparator: Standard Pravastatin Group

Active Comparator group

Treatment:

Drug: Pravastatin

Intensive Rosuvastatin Group

Active Comparator group

Treatment:

Drug: Rosuvastatin