In patient underwent PCI, low-dose aspirin undertaking for 6 months or more for the prevention of restenosis
Conditions
Interventions
PPI
H2RA
Sponsors
Stearing committee for LA-Study
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Available for low-dose aspirin successive treatments for 6 months or more (2)Age 25<= to 85>= (3)Out patients (4)Sufficient communication with investigators or physicians
Exclusion criteria
Exclusion criteria: (1)Hypersinsitivity for any drugs (2)Patient undertaking atazanavir sulfate (3)Patient with severe hepatic and/or renal disorders required any therapy (4)Patient with severe heart and/or lung disorders required any therapy (5)Pregnancy, possible pregnancy, or pregnancy hopeful (6)Upper gastrointestinal disorders (ulcer with hemrrhage, erosion unknown upper gastrointestinal hemmorhage (7)PPI taken with past 3 months (8)Patient with malignant neoplasm (9)Patient with surgery at esophagas duodenal and/or stomach (10)Perticipant in any other clinical trials within past 1 month (11)Patient whom investigators/physicins assessed inappropriate as a participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy:Incidence of gastrointestinal complications based on post-6-month Safety:Adverse events for 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of gastrointestinal hemorrhage and/or ulcer in patients with previous gastrointestinal ulcer, 2. Incidence ofgastrointestinal hemorrhage and/or ulcer in patients with 65 years old or more, 3.Infection rate with H. pylori, 4.Inprovement rate of gastrointestinal complications after 6 months treatment of dieretic agent | — |
Countries
Japan
Contacts
Public ContactHiroko Usami
BAIMEDIS INTERNATIONL Ltd Study Management Group
Outcome results
None listed