PrasugrEl moNotherapy after DrUg eLUting stent deployMent as a Management Of patients who are uNsuitable for lOng-term dual antiplatelet therapy

Not Applicable

• Conditions: Patient who underwent placement of a drug elution stent by percutaneous coronary intervention, have a high bleeding risk, and are considered to have a medical difficulty in receiving long-term administration of Aspirin

• Registration Number: JPRN-UMIN000028023
• Lead Sponsor: Toho University Ohashi Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-01
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1222

Inclusion Criteria

Not provided

Exclusion Criteria

Patients are excluded from the study if any one of the following criteria is met: 1. Patients who requires dual antiplatelet therapy (DAPT) for at least 6 months from the viewpoint of a thrombotic risk 2. Bleeding patients (e.g., hemophilia, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage) 3. Patients who underwent PCI in coronary artery bypass graft as the target lesion(s) 4. Patients who are participating or plan to participate in a clinical study or clinical research requiring intervention for the choice of antiplatelet therapy before the end of follow-up in this study 5. Patients who are participating in the clinical study titled: Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event (PENDULUM registry, UMIN000020332)

Study & Design

• Study Type: Others,meta-analysis etc
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of BARC type 2, 3, and 5 bleeding events from Month 1 to 12 after index PCI.

Secondary Outcome Measures

Name	Time	Method
To examine the incidence of events in the following A and B from Month 1 to 12 after index PCI. A. Bleeding events (each category in accordance with the BARC criteria, major bleeding and minor bleeding in the TIMI criteria) B. Cardiovascular events (all-cause death, cardiovascular death, non-lethal myocardial infarction, non-lethal stroke, non-lethal cerebral infarction, revascularization (TVR, TLR), transient ischemic attack (TIA), stent thrombosis, and peripheral artery occlusion) To examine the primary outcome (Bleeding in BARC 2,3 and 5 criteria) and secondary outcomes described above during the following evaluation periods in 1 to 3. <Evaluation period> 1. From 1 month to 24 months after PCI 2. During 12 months after PCI 3. During 24 months after PCI