CHIMU Okinawa Study

JRCT ID: jRCTs071180054

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: coronary heart disease
• Date of first enrollment: 17/03/2017
• Target sample size: 160
• Study type: Interventional

Intervention(s)

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 group, to measure and compare the platelet aggregation ability in verifynow.
CYP2C19 genetic test only to perform a genetic test of cyp2c19 involved in clopidogrel metabolism, to investigate the presence or absence of CYP2C19 gene allele, to evaluate the relationship between platelet aggregation ability and evaluation items.

Outcome(s)

• Primary Outcome: Platelet aggregation ability (PRU in VerifyNow) at the time of clopidogrel remedy and the prasugrel remedy

Secondary Outcome

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 revascularization
(a) TLR
(b) TVR
(c) Tvr-remote
(d) NON-TVR
(2) Coronary revascularization based on clinical adaptation
(a) TLR
(b) TVR
(c) Tvr-remote
(d) NON-TVR
(4) Events related to cerebrovascular disorders
The individual occurrence of the following items is an evaluation item.
1) Lethal and non-lethal cerebral hemorrhage
2) Lethal and non-lethal cerebral infarction
3) hospitalization due to transient cerebral ischemia attack
(5) Bleeding events
The individual occurrence of the following items is an evaluation item.
1) Hemorrhagic event
(6) Platelet aggregation (measurement by verifynow) and inspection items involved in Verifynow measurement
The rate of change and the amount of change of individual blood data of the following items is evaluated as an evaluation item.
1) blood test: Plt, RBC, Hb

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: iwabuchi Masashi
• Secondary Sponsor: Ohya Yusuke,Daiichi Sankyo Co., Ltd.
• Secondary ID(s): UMIN 000023489