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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2024 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-05-31

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.

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Detailed Description

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Conditions

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Coronary Occlusion/Thrombosis Peptic Ulcer Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Screening and risk assessment

Group Type ACTIVE_COMPARATOR

Screening for risk factors for ulcer bleeding

Intervention Type OTHER

Following PCI the patients fill out a questionnaire to assess the risk factors for ulcer bleeding.We randomise between:

1. screening and risk assessment
2. 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 \_\_\_

Interventions

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Screening for risk factors for ulcer bleeding

Following PCI the patients fill out a questionnaire to assess the risk factors for ulcer bleeding.We randomise between:

1. screening and risk assessment
2. 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 \_\_\_

Intervention Type OTHER

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.