Status:
TERMINATED
Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments
Lead Sponsor:
Positive Trial Group
Conditions:
Hypercholesterolemia
Type 2 Diabetes
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT01173939
Start Date
July 1 2010
Last Update
June 1 2011
Active Locations (317)
Enter a location and click search to find clinical trials sorted by distance.
1
Hiramitsu Heart Clinic
Nagoya, Aichi Pref., Japan
2
Medical Dock&Clinic
Nagoya, Aichi Pref., Japan
3
Matsuno Medical Clinic
Iyo Gun, Ehime Pref., Japan
4
Ishite Matsumoto Naika Junkanki Clinic
Matsuyama, Ehime Pref., Japan