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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Odense University Hospital
Sponsor:
Collaborators:
Aarhus University Hospital
Danish Heart Foundation
Region Southern Denmark
Information provided by (Responsible Party):
Berit Elin Søltoft Jensen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01447498
First received: September 26, 2011
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Coronary Occlusion/Thrombosis
Peptic Ulcer Hemorrhage
Other: Screening for risk factors for ulcer bleeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Admission for ulcer bleeding or haemorrhagic gastritis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Compliance with antithrombotic medicine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Does prophylactic treatment with Proton pump inhibitor increase the compliance with antithrombotic medicine and thereby decrease the risk of new cardiac event.

  • Identification of patients with Benefit of Proton pump inhibitor Prophylaxis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Analysis of risk factors is planned in order to define which patients have the greatest benefit of PPI prophylaxis when receiving antithrombotic treatment.

  • Gastrointestinal bleeding [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Admission to hospital for not endoskopic verified upper gastrointestinal bleeding.

  • Uncomplicated ulcers [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Development of uncomplicated ulcers

  • Death [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Registration of cause of death

  • Acute coronary syndrome [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Re-admission for acute coronary syndrome, including stent occlusion


Estimated Enrollment: 2000
Study Start Date: April 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ___


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447498

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Berit Elin Søltoft Jensen, MD       berit.elin@dadlnet.dk   
Sub-Investigator: Berit Elin Søltoft Jensen, MD         
Principal Investigator: Jane Møller Hansen, MD Ph.d.         
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Danish Heart Foundation
Region Southern Denmark
  More Information

No publications provided

Responsible Party: Berit Elin Søltoft Jensen, MD sub-investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01447498     History of Changes
Other Study ID Numbers: Projekt ASA
Study First Received: September 26, 2011
Last Updated: April 23, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on July 24, 2014