Coronary Artery DiseaseNCT01383304
Aspirin Response in High Risk Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Aarhus at 1 site in Denmark.
Trial summary
Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon "aspirin low-responsiveness". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Diabetes Mellitus
- How many people
- 906 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Jan 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 906 patients with CAD. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency. Eligible patients are identified in the Western Denmark Heart Registry.
Who may be able to join
- Coronary artery disease verified by coronary angiogram
- Treatment with aspirin 75 mg/d for at least the previous 7 days
- Previous myocardial infarction more than one year ago (groups with previous myocardial infarction)
- Type 2 diabetes mellitus treated with oral antidiabetics and/or insulin (groups with type 2 diabetes mellitus)
- Renal insufficiency; glomerular filtration rate <60 ml/min at the time of blood sampling (groups with renal insufficiency)
Who cannot join
- Treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function
- Ischemic vascular event within the previous 12 months
- Revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months
- Platelet count <120 x 10^9/L or >450 x 10^9/L
- For patients without diabetes: fast glucose >7 mmol/L
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Biochemistry, Aarhus University Hospital, Skejby
Aarhus N, 8200
About this study
Official title: Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?
Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon "aspirin low-responsiveness". Laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown.
The investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher risk of thrombosis.
The purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (CAD) having a reduced biochemical response to aspirin compared with CAD patients having a normal biochemical response to aspirin. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Diabetes Mellitus, Renal Insufficiency, Chronic
- Keywords
- Platelet aggregation, Aspirin, Drug resistance, Thromboxane B2, Pharmacologic Actions, Platelet Aggregation Inhibitors
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Diabetes Mellitus, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
Measured: Evaluation after 3 years
Secondary outcomes (2)
Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
Measured: Evaluation after 5 years
Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death
Measured: Evaluation after 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startNov 2007
- Primary completionJan 2011
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Danish Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Anne-Mette Hvas, MD, Ph.D, Principal investigator, Department of Clinical Biochemistry, Aarhus University Hospital, Skejby, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383304
- Sponsor's protocol ID
- 22527
- Status last verified
- May 2015
- First submitted
- 22 Jun 2011
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nielsen HL, Kristensen SD, Thygesen SS, Mortensen J, Pedersen SB, Grove EL, Hvas AM. Aspirin response evaluated by the VerifyNow Aspirin System and light transmission aggregometry. Thromb Res. 2008;123(2):267-73. doi: 10.1016/j.thromres.2008.03.023. Epub 2008 May 21.
PubMed 18499236Pedersen SB, Grove EL, Nielsen HL, Mortensen J, Kristensen SD, Hvas AM. Evaluation of aspirin response by Multiplate whole blood aggregometry and light transmission aggregometry. Platelets. 2009 Sep;20(6):415-20. doi: 10.1080/09537100903100643.
PubMed 19658002Hedegaard SS, Hvas AM, Grove EL, Refsgaard J, Rocca B, Davi G, Kristensen SD. Optical platelet aggregation versus thromboxane metabolites in healthy individuals and patients with stable coronary artery disease after low-dose aspirin administration. Thromb Res. 2009 May;124(1):96-100. doi: 10.1016/j.thromres.2008.12.034. Epub 2009 Feb 11.
PubMed 19215971Grove EL, Hvas AM, Johnsen HL, Hedegaard SS, Pedersen SB, Mortensen J, Kristensen SD. A comparison of platelet function tests and thromboxane metabolites to evaluate aspirin response in healthy individuals and patients with coronary artery disease. Thromb Haemost. 2010 Jun;103(6):1245-53. doi: 10.1160/TH09-08-0527. Epub 2010 Mar 29.
PubMed 20352155Mortensen SB, Larsen SB, Grove EL, Kristensen SD, Hvas AM. Reduced platelet response to aspirin in patients with coronary artery disease and type 2 diabetes mellitus. Thromb Res. 2010 Oct;126(4):e318-22. doi: 10.1016/j.thromres.2010.03.013. Epub 2010 May 7.
PubMed 20451957Larsen SB, Neergaard-Petersen S, Grove EL, Kristensen SD, Hvas AM. Increased platelet aggregation and serum thromboxane levels in aspirin-treated patients with prior myocardial infarction. Thromb Haemost. 2012 Jul;108(1):140-7. doi: 10.1160/TH12-01-0026. Epub 2012 Apr 26.
PubMed 22534977Wurtz M, Nissen PH, Grove EL, Kristensen SD, Hvas AM. Genetic determinants of on-aspirin platelet reactivity: focus on the influence of PEAR1. PLoS One. 2014 Oct 31;9(10):e111816. doi: 10.1371/journal.pone.0111816. eCollection 2014.
PubMed 25360888
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?
- ClinicalTrials.gov ID
- NCT01383304
- Acronym / sponsor ID
- 22527
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Diabetes Mellitus, Renal Insufficiency, Chronic
- Keywords
- Platelet aggregation, Aspirin, Drug resistance, Thromboxane B2, Pharmacologic Actions, Platelet Aggregation Inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 906 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Danish Heart Foundation
- Study start
- Nov 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 28 Jun 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.
Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon "aspirin low-responsiveness". Laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown.
The investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher risk of thrombosis.
The purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (CAD) having a reduced biochemical response to aspirin compared with CAD patients having a normal biochemical response to aspirin. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 906 patients with CAD. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency. Eligible patients are identified in the Western Denmark Heart Registry.
Key inclusion criteria (5 listed)
- Coronary artery disease verified by coronary angiogram
- Treatment with aspirin 75 mg/d for at least the previous 7 days
- Previous myocardial infarction more than one year ago (groups with previous myocardial infarction)
- Type 2 diabetes mellitus treated with oral antidiabetics and/or insulin (groups with type 2 diabetes mellitus)
- Renal insufficiency; glomerular filtration rate <60 ml/min at the time of blood sampling (groups with renal insufficiency)
Key exclusion criteria (6 listed)
- Treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function
- Ischemic vascular event within the previous 12 months
- Revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months
- Platelet count <120 x 10^9/L or >450 x 10^9/L
- For patients without diabetes: fast glucose >7 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
Time frame: Evaluation after 3 years
2 secondary outcomes
Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
Time frame: Evaluation after 5 years
Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death
Time frame: Evaluation after 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 18499236Nielsen HL, Kristensen SD, Thygesen SS, Mortensen J, Pedersen SB, Grove EL, Hvas AM. Aspirin response evaluated by the VerifyNow Aspirin System and light transmission aggregometry. Thromb Res. 2008;123(2):267-73. doi: 10.1016/j.thromres.2008.03.023. Epub 2008 May 21.
- Background: PubMed 19658002Pedersen SB, Grove EL, Nielsen HL, Mortensen J, Kristensen SD, Hvas AM. Evaluation of aspirin response by Multiplate whole blood aggregometry and light transmission aggregometry. Platelets. 2009 Sep;20(6):415-20. doi: 10.1080/09537100903100643.
- Background: PubMed 19215971Hedegaard SS, Hvas AM, Grove EL, Refsgaard J, Rocca B, Davi G, Kristensen SD. Optical platelet aggregation versus thromboxane metabolites in healthy individuals and patients with stable coronary artery disease after low-dose aspirin administration. Thromb Res. 2009 May;124(1):96-100. doi: 10.1016/j.thromres.2008.12.034. Epub 2009 Feb 11.
- Background: PubMed 20352155Grove EL, Hvas AM, Johnsen HL, Hedegaard SS, Pedersen SB, Mortensen J, Kristensen SD. A comparison of platelet function tests and thromboxane metabolites to evaluate aspirin response in healthy individuals and patients with coronary artery disease. Thromb Haemost. 2010 Jun;103(6):1245-53. doi: 10.1160/TH09-08-0527. Epub 2010 Mar 29.
- Background: PubMed 20451957Mortensen SB, Larsen SB, Grove EL, Kristensen SD, Hvas AM. Reduced platelet response to aspirin in patients with coronary artery disease and type 2 diabetes mellitus. Thromb Res. 2010 Oct;126(4):e318-22. doi: 10.1016/j.thromres.2010.03.013. Epub 2010 May 7.
- Results publication: PubMed 22534977Larsen SB, Neergaard-Petersen S, Grove EL, Kristensen SD, Hvas AM. Increased platelet aggregation and serum thromboxane levels in aspirin-treated patients with prior myocardial infarction. Thromb Haemost. 2012 Jul;108(1):140-7. doi: 10.1160/TH12-01-0026. Epub 2012 Apr 26.
- Derived from this study: PubMed 25360888Wurtz M, Nissen PH, Grove EL, Kristensen SD, Hvas AM. Genetic determinants of on-aspirin platelet reactivity: focus on the influence of PEAR1. PLoS One. 2014 Oct 31;9(10):e111816. doi: 10.1371/journal.pone.0111816. eCollection 2014.
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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.
Anne-Mette Hvas, MD, Ph.D principal investigator
Department of Clinical Biochemistry, Aarhus University Hospital, Skejby, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Aarhus 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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?
Results are not available in the source record.
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?
Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke (time frame: Evaluation after 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01383304, which also lists 7 linked publications.
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 12 May 2016.