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
Conditions
Interventions
None listed
Sponsors
Toho University Ohashi Medical Center
Daiichi Sankyo Co., LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are included in this study if all of the following criteria are met: 1. Patients 20 years of age or older at the time of informed consent 2. Patients who are indicated for PCI with drug eluting stent (Patients would be judged by referring product-package insert.) 3. Patients who are planned to be treated with prasugrel more than 12 months after PCI with drug eluting stent 4. Patients who satisfy at least one of the followings, and who is not medically preferable to administrate Aspirin concomitantly for long-term. (1) Complication of peptic ulcer (2) Having a history of bleeding (e.g., intracranial hemorrhage such as cerebral hemorrhage, pulmonary hemorrhage, gastrointestinal hemorrhage, ocular fundus bleeding) (3) Having a bleeding tendency (e.g., concurrent anemia, a hemoglobin level of less than 11 g/dL before PCI) (4) Having renal impairment (e.g., concurrent renal failure, dialysis, eGFR of less than 60 before PCI) (5)Continuous administration of nonsteroidal anti-inflammatory agents (NSAIDs) (other than Aspirin) after PCI is required (6)Continuous administration of oral anticoagulants (OACs) after PCI is required (7)Elderly (at least 75 years old when informed consent is obtained) (8) low body weight (<50kg) (9)Other patients who are considered to have a bleeding risk (Reason must be specified.) 5. Patients who have provided written consent to participate in the study (When emergency, patients would be asked to agree to participate in clinical study after their agent has agreed to do so.)
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of BARC type 2, 3, and 5 bleeding events from Month 1 to 12 after index PCI. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHideyuki Takeuchi
CMIC Co., Ltd. Clinical Operation 3rd Div.
Outcome results
None listed