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

NCT01447498 | Completed

• 1 other identifier: Projekt ASA
• Study Type: interventional
• Target: 2,024
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Occlusion/Thrombosis; Peptic Ulcer Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Compliance with antithrombotic medicine

  1 year

• Identification of patients with benefit of proton pump inhibitor prophylaxis

  1 year

• Gastrointestinal bleeding

  1 Year

• Uncomplicated ulcers

  1 year

• Death

  1 Year

Study Arms (2)

Control group

NO INTERVENTION

Screening and risk assessment

ACTIVE COMPARATOR

Other: Screening for risk factors for ulcer bleeding

Interventions

Screening for risk factors for ulcer bleeding OTHER

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 \_\_\_

Screening and risk assessment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator
• Danish Heart Foundation: collaborator
• Region of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Coronary Occlusion; Thrombosis; Peptic Ulcer Hemorrhage

Interventions

Mass Screening; Risk Factors

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Risk; Probability; Statistics as Topic; Causality; Epidemiologic Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD sub-investigator

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: October 6, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

DK (1)