Secondary Protective effect of ca-antagonist for ischemic heart attack randominzed parallel comparison with beta-blocker trial

UMIN ID: UMIN000000930

Registered date:04/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ischemic heart disease (post-myocardila infarction angina, angina pectoris)
• Date of first enrollment: 2002/07/01
• Target sample size: 800
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

atenolol-treated group dose: 50 mg QD maximum dose: 100mg Permission to change the dose according to age or symptoms.
benidipine-treated group dose: 4mg BID Permission to change the dose according to age or symptoms.
vasospastic angina patient group benidipine dose: 4mg BID Permission to change the dose according to age or symptoms.

Outcome(s)

• Primary Outcome: cardiovascular evetns including myocardial infarction, angina, silent myocardial ischemia, taget lesion revascularization, cerebral infarction, intracerebral hemorrhage
• Secondary Outcome: 1. all death 2. hospitalization due to heart failure etc 3. renal failure (hemodialysis)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) previous history of hypersensitivity or intolerance of atenolol or benidipine 2) cardiogenic shock 3)diabetic ketoacidosis, metabolic acidosis 4)severe or symptomatic bradycardia, atrioventricular block (II, III degree), sinoatrial block, sick sinus syndrome 5)critical arrhythmia 6)right ventricular failure with pulmonary hypertension 7)congestive heart failure 8)hypotension 9)severe peripheral arterial disease (gangrene etc) 10)untreated pheochromocytoma 11)any women who is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study 12)severe hepatic failure (total bilirubin >2.0mg/dL) 13)severe renal failure (serum creatinin >3.0mg/dL) 14)infection, paralytic or obstractive ileus 15)ongoing or planning treatment with anti-cancer drugs 16)other serious illness or significant abnormalities that the investigator judges inappropriate for the study

Related Information

• Primary Sponsor: Nippon Medical School
• Secondary Sponsor: Nippon Medical School, Chiba Hokusoh hospital, Musashi Kosugi hospital, Tama Nagayama hospital
• Source(s) of Monetary Support: Nippon Medical School, Department of Internal Medicine, division of cardiology