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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01447498
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : November 11, 2015
Aarhus University Hospital
Danish Heart Foundation
Region of Southern Denmark
Information provided by (Responsible Party):
Berit Elin Søltoft Jensen, Odense University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Occlusion/Thrombosis Peptic Ulcer Hemorrhage Other: Screening for risk factors for ulcer bleeding Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2024 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment
Study Start Date : April 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
No Intervention: Control group
Active Comparator: Screening and risk assessment 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 ___

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01447498

Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Danish Heart Foundation
Region of Southern Denmark

Responsible Party: Berit Elin Søltoft Jensen, MD sub-investigator, Odense University Hospital Identifier: NCT01447498     History of Changes
Other Study ID Numbers: Projekt ASA
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Peptic Ulcer
Coronary Occlusion
Peptic Ulcer Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Gastrointestinal Hemorrhage