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

Positive Trial Group10,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

10,000

Conditions

Hypercholesterolemia Type 2 Diabetes Hypertension

Interventions

5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)

RosuvastatinDRUG

5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (317)

Hiramitsu Heart Clinic

Nagoya, Aichi Pref., Japan

Medical Dock&Clinic

Nagoya, Aichi Pref., Japan

Matsuno Medical Clinic

Iyo Gun, Ehime Pref., Japan

Ishite Matsumoto Naika Junkanki Clinic

Matsuyama, Ehime Pref., Japan

Ehime Medical CO-OP Izumigawa Clinic

Niihama, Ehime Pref., Japan

Tsugawa Internal Medicine Clinic

Outcomes

Primary Outcomes

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

Time frame: At baseline

Time frame: 1 month after treatment initiation

Time frame: 3 month after treatment initiation

Time frame: 6 month after treatment initiation

Time frame: 12 month after treatment initiation

Time frame: 36 month after treatment initiation

Time frame: At the end of the study or discontinuation up to 4 years

Secondary Outcomes

Prevention of individual MACE

Time frame: At baseline

Prevention of MACE(combination of each category)

Time frame: At baseline

Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)

Time frame: At baseline

Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")

Time frame: At baseline

Frequency and distribution of type of deaths during the study period

Time frame: At baseline

Frequency and distribution of type of hospitalizations during the study period

Time frame: At baseline

Frequency of other events (malignancy, dementia, need of nursing care)

Time frame: At baseline

Frequency and type of adverse events

Time frame: At baseline

Prevention of individual MACE

Time frame: 1 month after treatment initiation

Prevention of individual MACE

Time frame: 3 month after treatment initiation

Prevention of individual MACE

Time frame: 6 month after treatment initiation

Prevention of individual MACE

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Echizen, Fukui Pref., Japan

Fukui Chuo Clinic

Fukui, Fukui Pref., Japan

Koshino Clinic

Sakai, Fukui Pref., Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka Pref., Japan

Saiseikai Futsukaichi Hospital

Chikushino-shi, Fukuoka Pref., Japan

...and 307 more locations

Time frame: 12 month after treatment initiation

Prevention of individual MACE

Time frame: 36 month after treatment initiation

Prevention of individual MACE

Time frame: At the end of the study (or discontinuation)

Prevention of MACE(combination of each category)

Time frame: 1 month after treatment initiation

Prevention of MACE(combination of each category)

Time frame: 3 month after treatment initiation

Prevention of MACE(combination of each category)

Time frame: 6 month after treatment initiation

Prevention of MACE(combination of each category)

Time frame: 12 month after treatment initiation

Prevention of MACE(combination of each category)

Time frame: 36 month after treatment initiation

Prevention of MACE(combination of each category)

Time frame: At the end of the study (or discontinuation)

Time frame: 1 month after treatment initiation

Time frame: 3 month after treatment initiation

Time frame: 6 month after treatment initiation

Time frame: 12 month after treatment initiation

Time frame: 36 month after treatment initiation

Time frame: At study completion up to 4 years

Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")

Time frame: 1 month after treatment initiation

Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")

Time frame: 3 month after treatment initiation

Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")

Time frame: 6 month after treatment initiation

Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")

Time frame: 12 month after treatment initiation

Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")

Time frame: 36 month after treatment initiation

Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")

Time frame: At the end of the study or discontinuation up to 4 years

Frequency and distribution of type of deaths during the study period

Time frame: 1 month after treatment initiation

Frequency and distribution of type of deaths during the study period

Time frame: 3 month after treatment initiation

Frequency and distribution of type of deaths during the study period

Time frame: 6 month after treatment initiation

Frequency and distribution of type of deaths during the study period

Time frame: 12 month after treatment initiation

Frequency and distribution of type of deaths during the study period

Time frame: 36 month after treatment initiation

Frequency and distribution of type of deaths during the study period

Time frame: At the end of the study or discontinuation up to 4 years

Frequency and distribution of type of hospitalizations during the study period

Time frame: 1 month after treatment initiation

Frequency and distribution of type of hospitalizations during the study period

Time frame: 3 month after treatment initiation

Frequency and distribution of type of hospitalizations during the study period

Time frame: 6 month after treatment initiation

Frequency and distribution of type of hospitalizations during the study period

Time frame: 12 month after treatment initiation

Frequency and distribution of type of hospitalizations during the study period

Time frame: 36 month after treatment initiation

Frequency and distribution of type of hospitalizations during the study period

Time frame: At the end of the study or discontinuation up to 4 years

Frequency of other events (malignancy, dementia, need of nursing care)

Time frame: 1 month after treatment initiation

Frequency of other events (malignancy, dementia, need of nursing care)

Time frame: 3 month after treatment initiation

Frequency of other events (malignancy, dementia, need of nursing care)

Time frame: 6 month after treatment initiation

Frequency of other events (malignancy, dementia, need of nursing care)

Time frame: 12 month after treatment initiation

Frequency of other events (malignancy, dementia, need of nursing care)

Time frame: 36 month after treatment initiation

Frequency of other events (malignancy, dementia, need of nursing care)

Time frame: At the end of the study or discontinuation up to 4 years

Frequency and type of adverse events

Time frame: 1 month after treatment initiation

Frequency and type of adverse events

Time frame: 3 month after treatment initiation

Frequency and type of adverse events

Time frame: 6 month after treatment initiation

Frequency and type of adverse events

Time frame: 12 month after treatment initiation

Frequency and type of adverse events

Time frame: 36 month after treatment initiation

Frequency and type of adverse events

Time frame: At the end of the study or discontinuation up to 4 years