Coronary Occlusion/Thrombosis | Systematic Screening for Risk-factors for Ulcer Bleeding Before Anti-thrombotic Treatment
Coronary Occlusion/Thrombosis research study
What is the primary objective of this study?
In a prospective randomised study design to investigate, if a systematic risk factor screening for bleeding ulcer in patients, who following percutaneous coronary intervention (PCI) commence a one year combination treatment with low dose aspirin and clopidogrel, followed by prophylactic treatment with a proton pump inhibitor (PPI) in case of increased risk, can reduce the risk of bleeding ulcer. Based on the recently raised suspicion that PPI's, possibly except pantoprazole, reduce the effect of ADP-receptor inhibitors, pantoprazole has been chosen as prophylaxis in the screening group, and analyses will be done to ascertain whether PPI treatment increases the risk of coronary events. Further analyses will be made to see whether PPI prophylaxis in high risk patients can increase compliance with the antithrombotic treatment through a reduction of side effects, thereby reducing the risk of myocardial infarction in particular stent thrombosis. The study population will be analyzed further to identify the patients, who will benefit the most from PPI prophylaxis Hypothesis: screening heart patients for risk factors for bleeding ulcer and subsequently treating high risk patients with PPI can reduce the incidence of bleeding ulcer and increase compliance with the antithrombotic treatment; thereby possibly reducing the risk of coronary events and improving survival. Initial a description of the prevalence of risk factors will be done.
Who is eligible to participate?
Inclusion Criteria: - Patients who has had a PCI with stenting or balloon dilatation in the cardiology department at Odense University Hospital, Århus University Hospital and Ålborg Sygehus, where subsequent treatment with low-dose aspiring and clopidogrel or another thienopyridine is planned for one year. Exclusion Criteria: - previous PCI with stenting or balloon dilatation - treatment with clopidogrel prior to PCI - lack of informed consent
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Peptic Ulcer Hemorrhage
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Screening for risk factors for ulcer bleedingFollowing PCI the patients fill out a questionnaire to assess the risk factors for ulcer bleeding.We randomise between: screening and risk assessment control group All screened patients, who fulfil the criteria for having a moderate to high risk of ulcer bleeding will be sent written information about risk factors and the purpose of the PPI prophylaxis. They will be recommended PPI prophylaxis (Pantoprazole), as long as they are being treated with low-dose aspirin and clopidogrel. Patients in the screening group, who are already on PPI treatment is recommended to change to Pantoprazole. Definition of risk of ulcer bleeding: The table below will be used for screening. Patients scoring ≥ 2 points will receive PPI prophylaxis. points: Age: < 60: 0; 60-69: 1; 70-79: 2; >=80: 3 ___ Dyspepsia: 1 ___ Uncomplicated ulcer: 2 ___ Complicated ulcer 3 ___ NSAID 2 ___ Steroids 2 ___ SSRI 2 ___ Anticoagulant Tx 2 ___
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Screening and risk assessment
Start Date: April 2011
Completed Date: May 2014
Primary Outcome: Admission for ulcer bleeding or haemorrhagic gastritis
Secondary Outcome: Compliance with antithrombotic medicine
Study sponsors, principal investigator, and references
Lead Sponsor: Odense University Hospital
Collaborator: Aarhus University Hospital