Systematic Screening for Risk-factors for Ulcer Bleeding Before Anti-thrombotic Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment

Conditions
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Coronary Occlusion/Thrombosis, Peptic Ulcer Hemorrhage

Intervention / Treatment
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* Other: Screening for risk factors for ulcer bleeding


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Active Comparator: Screening and risk assessment<br> | Other: Screening for risk factors for ulcer bleeding<br>* Following 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 ___<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission for ulcer bleeding or haemorrhagic gastritis | Efficacy of a systematic screening for risk factors for ulcer bleeding in patients, who after percutaneous coronary intervention (PCI), is treated with antithrombotic medicine | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with antithrombotic medicine | Does prophylactic treatment with proton pump inhibitor increase the compliance with antithrombotic medicine and thereby decrease the risk of new cardiac event. | 1 year | 
| Identification of patients with benefit of proton pump inhibitor prophylaxis | Analysis of risk factors is planned in order to define which patients have the greatest benefit of PPI prophylaxis when receiving antithrombotic treatment. | 1 year | 
| Gastrointestinal bleeding | Admission to hospital for not endoscopic verified upper gastrointestinal bleeding. | 1 Year | 
| Uncomplicated ulcers | Development of uncomplicated ulcers | 1 year | 
| Death | Registration of cause of death | 1 Year | 
| Acute coronary syndrome | Re-admission for acute coronary syndrome, including stent occlusion | 1 Year |