Dyslipidemia with high LDL cholesterol (LDL-C) levels, Coronary artery disease
Conditions
Interventions
Continuing the former lipid lowering therapy
Adding probucol with the former lipid lowering therapy
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been diagnosed as dyslipidemia with high LDL-C level 2) Patients who are taking lipid lowering drugs 3) Patients whose LDL-C level was from 100 to 200 mg/dl by the blood test within 8 weeks before the informed consents (LDL-C should be calculated by the Friedewald formula: LDL-C= TC-HDL-C-TG/5) 4) Patients who have a history of following coronary heart diseases; myocardial infarction or angina pectoris, and whose onset of the disease was more than 3 months before CABG which was performed more than 3 months before PCI which was undergone more than nine months before or no restenosis which was diagnosed by the follow-up coronary angiography, 6-9 months after PCI 5) Patients who are suffering from mild to moderate heart failure. (NYHA classification I or II) 6) Patients who are over 20 years old at the time of informed consent 7) Patients whose hepatic and renal functions are normal, AST<100 IU/L, ALT<100 IU/L, serum creatinine<1.5 IU/L, data from the blood test within 4 weeks before the time of informed consents 8) Patients who have given written informed consent for participating in this study
Exclusion criteria
Exclusion criteria: 1) Patients who have taken probucol within 6 months before the time of informed consents 2) Patients who are currently taking cyclosporin 3) Patients who have a past history of hypersensitivity reactions to probucol 4) Patients who have already been diagnosed as familial hypercholesterolemia based on NICE Clinical Guideline 71 (Atherosclerosis 2003;168:1-14) 5) Patients whose TG level was over 400 mg/dl within 8 weeks before the time of informed consents 6) Patients whose HbA1c level was over 8 % by the latest blood test 7) Patients who have electrocardiographically been confirmed to have frequent multifocal ventricular arrhythmia 8) Patients who have been confirmed to have atrial fibrillation (Af) including paroxysmal Af 9) Patients whose QTc interval in resting electrocardiogram was >450 msec in males or >470 msec in females, respectively 10) Patients who have congestive heart failure or unstable angina 11) Patients who have been participating in other clinical trials 12) Patients who are pregnant, lactating or have the possibility of pregnancy or the wish of pregnancy within this study period 13) Patients whom were considered inappropriate by the doctors for participation in the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebrovascular or cardiovascular events and the duration from the enrollment. Following diseases were recognized; 1) death due to cardiovascular diseases including sudden death 2) nonfatal myocardial infarction 3) nonfatal cerebral stroke (excluding transient ischemic attack, TIA) 4) hospitalization for unstable angina 5) hospitalization for heart failure 6) coronary revascularization (percutaneous coronary interventions, PCI or coronary artery bypass graft, CABG) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) All deaths 2) All cardiovascular and cerebrovascular diseases 3) Event free survival time 4) Levels of the mean intima media thickness(IMT) of carotid arteries and their changes 5) Levels of max IMT in common or internal carotid arteries and their changes 6) Severe adverse events and their frequency | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactDaisaku Masuda
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed