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

Not Applicable

Completed

• Conditions: Coronary Occlusion/Thrombosis; Peptic Ulcer Hemorrhage
• Interventions: Other: Screening for risk factors for ulcer bleeding

• Registration Number: NCT01447498
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2024

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.

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Exclusion Criteria

• previous PCI with stenting or balloon dilatation
• treatment with clopidogrel prior to PCI
• lack of informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening and risk assessment	Screening for risk factors for ulcer bleeding	-

Primary Outcome Measures

Name	Time	Method
Admission for ulcer bleeding or haemorrhagic gastritis	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

Name	Time	Method
Compliance with antithrombotic medicine	1 year	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	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.
Gastrointestinal bleeding	1 Year	Admission to hospital for not endoscopic verified upper gastrointestinal bleeding.
Uncomplicated ulcers	1 year	Development of uncomplicated ulcers
Death	1 Year	Registration of cause of death
Acute coronary syndrome	1 Year	Re-admission for acute coronary syndrome, including stent occlusion

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark