Comparative study to examine the effects of changing between thienopyridine drugs on platelet aggregation activity for patients who are consistently treated with dual antiplatelet therapy: DAPT (clopidogrel + aspirin) over 52 weeks

Not Applicable

• Conditions: Ischemic heart disease

• Registration Number: JPRN-UMIN000027089
• Lead Sponsor: Kurume University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of patients who achieve PRU value <208 after 12 weeks.

Secondary Outcome Measures

Name	Time	Method
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