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

NCT01447498 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2024

Last updated 2015-11-11

No results posted yet for this study

Summary

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.

Conditions

  • Coronary Occlusion/Thrombosis
  • Peptic Ulcer Hemorrhage

Interventions

OTHER

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 \_\_\_

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Danish Heart Foundation

    collaborator OTHER

  • Region of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447498 on ClinicalTrials.gov