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

Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI 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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Hemorrhage; Coronary Occlusion/Thrombosis
• Intervention / Treatment: Other: Screening for risk factors for ulcer bleeding

• Study Type: Interventional
• Enrollment (Actual): 2024
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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 ___

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admission for ulcer bleeding or haemorrhagic gastritis	Efficacy of a systematic screening for risk factors for ulcer bleeding in patients, who after percutaneous coronary intervention (PCI), is treated with antithrombotic medicine	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with antithrombotic medicine	Does prophylactic treatment with proton pump inhibitor increase the compliance with antithrombotic medicine and thereby decrease the risk of new cardiac event.	1 year
Identification of patients with benefit of proton pump inhibitor prophylaxis	Analysis of risk factors is planned in order to define which patients have the greatest benefit of PPI prophylaxis when receiving antithrombotic treatment.	1 year
Gastrointestinal bleeding	Admission to hospital for not endoscopic verified upper gastrointestinal bleeding.	1 Year
Uncomplicated ulcers	Development of uncomplicated ulcers	1 year
Death	Registration of cause of death	1 Year
Acute coronary syndrome	Re-admission for acute coronary syndrome, including stent occlusion	1 Year

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Aarhus University Hospital; Region of Southern Denmark; Danish Heart Foundation

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): November 11, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Stomach Diseases; Embolism and Thrombosis; Intestinal Diseases; Coronary Disease; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Thrombosis; Coronary Occlusion; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: Projekt ASA