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Completed

NCT Number: NCT01447498

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening for risk factors for ulcer bleeding

Other

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 ___

Primary outcomes

  1. Admission for ulcer bleeding or haemorrhagic gastritis

    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

Secondary outcomes

  1. Compliance 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.

  2. Identification of patients with benefit of proton pump inhibitor prophylaxis

    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.

  3. Gastrointestinal bleeding

    Time frame: 1 Year

    Admission to hospital for not endoscopic verified upper gastrointestinal bleeding.

  4. Uncomplicated ulcers

    Time frame: 1 year

    Development of uncomplicated ulcers

  5. Death

    Time frame: 1 Year

    Registration of cause of death

  6. Acute coronary syndrome

    Time frame: 1 Year

    Re-admission for acute coronary syndrome, including stent occlusion

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Danish Heart Foundation
  • Region of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 6, 2011
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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