A randomized control study to see the effect of intensive treatment of hypertension and hyperlipidemia on patients having documented coronary artery disease.

UMIN ID: UMIN000000571

Registered date:29/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients diagnosed as having 75% or higher stenosis according to the AHA classification in at least one branch of the coronary artery with hypertension and hyperlipidemia.
• Date of first enrollment: 2006/11/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intensive Therapy Therapeutic Target BP <120/80mmHg LDL-C <80mg/dL
Conventional Therapy Therapeutic Target BP <140/90mmHg LDL-C <100mg/dL

Outcome(s)

• Primary Outcome: Composite endpoint - all deaths, nonfatal MI/stroke/vascular/peripheral vessel events, unstable angina pectoris, all hospitalization and CABG Evaluated three years after intervention started.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: Patients are excluded from study inclusion if they have 1) allergy to test drugs 2) familial hypercholesterolemia 3) uncontrolled hyperlipidemia (LDL-C >= 180mg/dL) 4) uncontrolled hypertension (systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg) 5) AMI and/or stroke within 3months before intervention 6) secondary hypertension 7) secondary hyperlipidemia 8) severe valvular disease including mitral stenosis or incompetence of the aortic valve 9) severe arrhythmia including ventricular fibrillation or ventricular tachyrhythmia 10) renal failure (serum creatinine >=2.5 mg/dL) 11) liver dysfunction (AST and/or ALT over three times the normal value) 12) pregnancy and/or possibility of pregnancy or if the attending doctor disqaulifies the patients to be included in the study for whatever reason.

Related Information

• Primary Sponsor: J-CADII study committee
• Source(s) of Monetary Support: Japan Heart Foundation