Odense University Hospital
Odense, 5000, Denmark
NCT Number: NCT01447498
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.
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Interventional
Not applicable
Odense, 5000, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following PCI the patients fill out a questionnaire to assess the risk factors for ulcer bleeding.We randomise between:
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 ___
Time frame: 1 year
Efficacy of a systematic screening for risk factors for ulcer bleeding in patients, who after percutaneous coronary intervention (PCI), is treated with antithrombotic medicine
Time frame: 1 year
Does prophylactic treatment with proton pump inhibitor increase the compliance with antithrombotic medicine and thereby decrease the risk of new cardiac event.
Time frame: 1 year
Analysis of risk factors is planned in order to define which patients have the greatest benefit of PPI prophylaxis when receiving antithrombotic treatment.
Time frame: 1 Year
Admission to hospital for not endoscopic verified upper gastrointestinal bleeding.
Time frame: 1 year
Development of uncomplicated ulcers
Time frame: 1 Year
Registration of cause of death
Time frame: 1 Year
Re-admission for acute coronary syndrome, including stent occlusion
Odense University Hospital
Other
Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment
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