coronary heart disease
Conditions
Interventions
Patients with chronic coronary artery disease taking aspirin and clopidogrel (Maintenance dose) for more than a month.
After placing the Clopidogrel continuation group and the positive Grain change gr
Sponsors
iwabuchi Masashi
Ohya Yusuke
Daiichi Sankyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have chronic coronary artery disease patients who are taking aspirin and clopidogrel for more than 1 month and satisfy the following items (1) Patients whose age at agreement acquisition is 20 years old or over and under 85 years old and whose body weight is 50 kg or more (2) Patients who gave adequate explanation on the participation of this study and gained written consent
Exclusion criteria
Exclusion criteria: 1)Dialysis 2)Dangerously ill liver disease patient 3)Malignant tumor of the activity 4)The patient that art of planned coronary revasculalization is not completed 5)PCI enforcement patients within 7 days 6)Dangerously ill heart failure patient(LVEFless than 30%. NYHA IV) 7)More than less than 50,000 number of the platelets /micro l or 500,000 /micro l, it is less than 30% of hematocrit or more than 50% 8)Bleeding patient 9)Patients who need treatment with anticoagulant 10)The patient who is participating in other clinical trials 11)Pregnant patient 12)the patient who judged that the medical attendant was inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet aggregation ability (PRU in VerifyNow) at the time of clopidogrel remedy and the prasugrel remedy | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications including cardiovascular events and bleeding after clopidogrel continuation or after one month of positive greal changes (1) Cardiovascular events 1) combined event of coronary artery disease Among the events of any of the following items, the earliest occurrence is the evaluation item. Cardiac sudden death, fatal/non-lethal myocardial infarction *, coronary revascularization based on unstable angina and clinical findings requiring emergency hospitalization and coronary revascularization. Among the evaluation items, the myocardial infarction with *, myocardial infarction associated with percutaneous coronary intervention or coronary artery bypass surgery is not included. 2) Multi-event of cerebrovascular disorder Among the events of any of the following items, the earliest occurrence is the evaluation item. Fatal/non-lethal stroke, temporary cerebral ischemia, hospitalization (2) Death events The individual occurrence of the following items is an evaluation item. 1) Total deaths 2) Cardiovascular Death 3) Heart death What is cardiovascular death?: Myocardial infarction, cerebral infarction, angina pectoris, carotid stenosis, closed sclerosis, Venous thromboembolic disease, lymphedema, thoracic aortic aneurysm, abdominal aneurysms, varicose veins Heart death: Sudden death and cardiac dysfunction (3) Events related to heart disease The individual occurrence of the following items is an evaluation item. 1) Lethal and non-lethal myocardial infarction * 2) myocardial infarction associated with percutaneous coronary intervention 3) myocardial infarction associated with coronary artery bypass surgery 4) Myocardial infarction associated with stent thrombosis 5) Sudden death 6) unstable angina that required emergency hospitalization and needed coronary revascularization 7) resuscitation from cardiac arrest 8) hospitalization by heart failure 9) New onset of atrial fibrillation 10) Enforcement of coronary revascularization (PCI or CABG) (1) All coronary revascu | — |
Contacts
Public ContactMai Nakahodo
Graduate School of Medicine,Univercity of the Ryukyus
Outcome results
None listed