Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01447498
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2011-09-26
Brief Title:
Systematic Screening for Risk-factors for Ulcer Bleeding Before Anti-thrombotic Treatment
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PPIs 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None