Systematic Screening for Risk-factors for Ulcer Bleeding Before Anti-thrombotic Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01447498|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Occlusion/Thrombosis Peptic Ulcer Hemorrhage||Other: Screening for risk factors for ulcer bleeding||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2024 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
|No Intervention: Control group|
|Active Comparator: Screening and risk assessment||
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:
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 ___
- Admission for ulcer bleeding or haemorrhagic gastritis [ Time Frame: 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
- Compliance with antithrombotic medicine [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 Year ]Admission to hospital for not endoscopic verified upper gastrointestinal bleeding.
- Uncomplicated ulcers [ Time Frame: 1 year ]Development of uncomplicated ulcers
- Death [ Time Frame: 1 Year ]Registration of cause of death
- Acute coronary syndrome [ Time Frame: 1 Year ]Re-admission for acute coronary syndrome, including stent occlusion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447498
|Odense University Hospital|
|Odense, Denmark, 5000|