NCT01447498

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,024 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Occlusion/Thrombosis
• Peptic Ulcer Hemorrhage

Interventions

Type	Name	Description
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 \_\_\_

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-10-06
• Last updated: 2015-11-11

Locations

1 site across 1 country: Denmark