None listed
Conditions
Interventions
Drug : Patients undergoing coronary artery intervention for acute myocardial infarction were randomly assigned to either the P-CAB-based gastrointestinal bleeding protection strategy group (experiment
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Patients must be at least 19 years of age ii) Patients presenting with AMI (ST-segment elevation MI [STEMI] or non-ST-segment elevation MI [NSTEMI]). iii) Patients undergoing PCI with drug-eluting stents or drug-eluting balloon angioplasty iv) Patients who can understand risks, benefits and treatment alternatives and sign informed consent voluntarily. v) Patients who suspect gastrointestinal reflux disease
Exclusion criteria
Exclusion criteria: i) Known hypersensitivity or contraindications to study medications (P-CAB or proton pump inhibitor [PPI]) ii) Current gastrointestinal bleeding iii) Pregnant or lactating women iv) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator’s medical judgment) v) Patients who refuse to participate in the study or who have difficulty complying with the requirements specified in the research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NACE (A composite of death from any causes, MI, stroke, or Bleeding Academic Research Consortium [BARC] type 3-5 bleeding) at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Upper gastrointestinal clinical events at 1 year;Gastroesophageal reflux disease (GERD) at 1 year | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo-yong Hahn
Samsung Medical Center
Outcome results
None listed