Ischemic heart disease
Conditions
Interventions
Sponsors
Kurume University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who underwent coronary artery stent implantation and have consistently treated with dual antiplatelet therapy (DAPT: clopidogrel + aspirin) over 52 weeks. 2)Patients aged 20 years or older (at the time of informed consent) 3)Patients who have provided written consent to participate in the study 4)Patients who have provided consent to collection and analysis of samples for genetic analysis 5)Patients who are able to understand the nature of the study and follow the study procedures in the opinion of the study investigator.
Exclusion criteria
Exclusion criteria: 1)Patients with bleeding tendency or diathesis thereof 2)Patients with severe hepatic impairment 3)Patients with severe renal impairment 4)Patients with poorly controlled blood pressure receiving antihypertensive therapy. 5)Patients with a history of cerebral infarction or transient ischemic attack 6)Patients with a history of hypersensitivity to thienopyridine drugs such as ticlopidine, prasugrel, clopidogrel. 7)Female who are pregnant, suspected to pregnant, wish to be pregnant, or lactating. 8)Patients who are mentally incompetent (including moderate or serious dementia) and not to gain understanding and cooperation judged by Investigator 9)Patients who are hospitalized during the observation period, or needs to be hospitalized during the research period judged by Investigator. 10)Patients who need to receive treatment with prohibited concomitant drugs during the study 11)Patients disqualified from participation in the study by the principal investigator or study investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of patients who achieve PRU value <208 after 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Epidemiological classification by DAPT score. 2. PRU value by CYP2C19 genetic polymorphism at STEP 1. 3. Change in PRU value after 12 weeks. 4. Change in PRU value by CYP2C19 genetic polymorphism after 12 weeks. 5. Change in platelet-derived microparticle after 12 weeks.* 6. Incidence of bleeding and cardiovascular events. 7. Platelet-derived microparticle by CYP2C19 genetic polymorphism.* 8. Change in cytokines, such as inflammatory markers, by Bio-Plex.* 9. Change in activity of accumulated FDG (Fluoro-deoxyglucose) by PET/CT.* *Only applicable to study participants in Kurume University Hospital | — |
Countries
Japan
Contacts
Public ContactTakafumi Ueno
Kurume University Hospital Center of Cardio-vascular Disease
Outcome results
None listed