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

Peptic Ulcer Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447498
• Other study ID #: Projekt ASA
• Status: Completed
• Phase: N/A
• First received: September 26, 2011
• Last updated: November 9, 2015
• Start date: April 2011
• Est. completion date: May 2014

Study information

• Verified date: November 2015
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2024
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Coronary Occlusion
• Coronary Occlusion/Thrombosis
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

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 ___

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital, Danish Heart Foundation, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Gastrointestinal bleeding	Admission to hospital for not endoscopic verified upper gastrointestinal bleeding.	1 Year	Yes
Secondary	Uncomplicated ulcers	Development of uncomplicated ulcers	1 year	Yes
Secondary	Death	Registration of cause of death	1 Year	Yes
Secondary	Acute coronary syndrome	Re-admission for acute coronary syndrome, including stent occlusion	1 Year	Yes