Coronary Occlusion/ThrombosisNCT01447498
Systematic Screening for Risk-factors for Ulcer Bleeding Before Anti-thrombotic Treatment
A study testing Screening for risk factors for ulcer bleeding in people with Coronary Occlusion/Thrombosis and Peptic Ulcer Hemorrhage, run by Odense University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Occlusion/Thrombosis, Peptic Ulcer Hemorrhage
- What is being tested?
- Screening for risk factors for ulcer bleeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,024 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- previous PCI with stenting or balloon dilatation
- treatment with clopidogrel prior to PCI
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment
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.
- Being tested
- Screening for risk factors for ulcer bleeding
- Medical subject headings
- Coronary Occlusion, Thrombosis, Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for risk factors for ulcer bleedingOther
Following PCI the patients fill out a questionnaire to assess the risk factors for ulcer bleeding.We randomise between:
- screening and risk assessment
- 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 ___
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Screening and risk assessment | Active comparator | Not described Receives: Other: Screening for risk factors for ulcer bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
Compliance with antithrombotic medicine
Does prophylactic treatment with proton pump inhibitor increase the compliance with antithrombotic medicine and thereby decrease the risk of new cardiac event.
Measured: 1 year
Identification of patients with benefit of proton pump inhibitor prophylaxis
Analysis of risk factors is planned in order to define which patients have the greatest benefit of PPI prophylaxis when receiving antithrombotic treatment.
Measured: 1 year
Gastrointestinal bleeding
Admission to hospital for not endoscopic verified upper gastrointestinal bleeding.
Measured: 1 Year
Uncomplicated ulcers
Development of uncomplicated ulcers
Measured: 1 year
Death
Registration of cause of death
Measured: 1 Year
Acute coronary syndrome
Re-admission for acute coronary syndrome, including stent occlusion
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Occlusion/ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Danish Heart Foundation, Region of Southern Denmark
- Responsible party
- Principal investigator, Berit Elin Søltoft Jensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447498
- Sponsor's protocol ID
- Projekt ASA
- Status last verified
- Nov 2015
- First submitted
- 26 Sep 2011
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment
- ClinicalTrials.gov ID
- NCT01447498
- Acronym / sponsor ID
- Projekt ASA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,024 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Danish Heart Foundation, Region of Southern Denmark
- Study start
- Apr 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Screening and risk assessment | Active comparator | Other: Screening for risk factors for ulcer bleeding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- previous PCI with stenting or balloon dilatation
- treatment with clopidogrel prior to PCI
- lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for risk factors for ulcer bleedingFollowing 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 ___ | Other | Screening and risk assessment |
Primary outcome
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
6 secondary outcomes
Compliance with antithrombotic medicine
Time frame: 1 year
Identification of patients with benefit of proton pump inhibitor prophylaxis
Time frame: 1 year
Gastrointestinal bleeding
Time frame: 1 Year
Uncomplicated ulcers
Time frame: 1 year
Death
Time frame: 1 Year
Acute coronary syndrome
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for risk factors for ulcer bleeding in people with Coronary Occlusion/Thrombosis and Peptic Ulcer Hemorrhage, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission for ulcer bleeding or haemorrhagic gastritis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015; AzTrials last refreshed its copy on 30 Oct 2026.