Drug ResistanceNCT00563875
Laboratory Aspirin Resistance in Diabetics and Non-Diabetics
A study testing acetylsalicylic acid in people with Drug Resistance, run by University of Aarhus at 1 site in Denmark.
Trial summary
Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Resistance
- What is being tested?
- acetylsalicylic acid
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Jun 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic heart disease verified by coronary angiogram (group:"CAD")
- treatment with aspirin 75 mg/d for at least the previous 7 days(groups: "CAD" and "Previous myocardial infarction")
- type II diabetes mellitus (~50% of groups: "CAD" and "Previous myocardial infarction")
- ≥ 1 myocardial infarction more than one year ago while taking daily aspirin ≥ 75 mg/d (group: "Previous myocardial infarction").
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
- intake of NSAIDs within 1 week of myocardial infarction (group: "Previous myocardial infarction").
- platelet count < 120 x 10^9/l
- previous myocardial infarction (group: "CAD").
- not able to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Biochemistry, Centre for Haemophilia and Thrombosis, Aarhus University Hospital Skejby
Aarhus N, DK - 8200
About this study
Official title: Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus
Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. Furthermore, patients with diabetes mellitus have an increased risk of myocardial infarction and other vascular events and, recently, it has been suggested that diabetics do not respond adequately to aspirin. The purpose of this study is to compare the prevalence of "aspirin resistance" in diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while being treated with aspirin are included. We hypothesize that the prevalence of "aspirin resistance" will be higher among diabetics compared to other patients and to healthy individuals.
Read the detailed description
A considerable number of patients suffer acute coronary events despite being treated with antiplatelet therapy such as aspirin. Taken together with laboratory findings of a low response to aspirin, the term "aspirin resistance" has been coined. Diabetics have an increased risk of suffering ischemic vascular events and, recently, an increased prevalence of "aspirin resistance" was reported in these patients. The purpose of the present study is to compare the aspirin response in diabetics and non-diabetics in a population with angiogram-verified coronary artery disease. Furthermore, healthy volunteers and patients who suffered a myocardial infarction while being treated with aspirin are included. Eligible patients are identified in the Western Denmark Heart Registry.
- Conditions
- Drug Resistance
- Being tested
- acetylsalicylic acid
- Keywords
- Platelets, Platelet aggregation, Drug resistance, Aspirin, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
Also called Hjerdyl (Sandoz)
75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation
Measured: (at least) one hour after aspirin ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ResistanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Steen D Kristensen, M.D., DMSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563875
- Sponsor's protocol ID
- 20070180
- Other IDs
- DDPA-2007-41-1207, DRA-2101-05-0052
- Status last verified
- Jun 2008
- First submitted
- 23 Nov 2007
- Last updated
- 10 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00563875
- Acronym / sponsor ID
- 20070180
- Conditions
- Drug Resistance
- Keywords
- Platelets, Platelet aggregation, Drug resistance, Aspirin, Diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 26 Nov 2007 (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.
Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. Furthermore, patients with diabetes mellitus have an increased risk of myocardial infarction and other vascular events and, recently, it has been suggested that diabetics do not respond adequately to aspirin. The purpose of this study is to compare the prevalence of "aspirin resistance" in diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while being treated with aspirin are included. We hypothesize that the prevalence of "aspirin resistance" will be higher among diabetics compared to other patients and to healthy individuals.
Detailed description
A considerable number of patients suffer acute coronary events despite being treated with antiplatelet therapy such as aspirin. Taken together with laboratory findings of a low response to aspirin, the term "aspirin resistance" has been coined. Diabetics have an increased risk of suffering ischemic vascular events and, recently, an increased prevalence of "aspirin resistance" was reported in these patients. The purpose of the present study is to compare the aspirin response in diabetics and non-diabetics in a population with angiogram-verified coronary artery disease. Furthermore, healthy volunteers and patients who suffered a myocardial infarction while being treated with aspirin are included. Eligible patients are identified in the Western Denmark Heart Registry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic heart disease verified by coronary angiogram (group:"CAD")
- treatment with aspirin 75 mg/d for at least the previous 7 days(groups: "CAD" and "Previous myocardial infarction")
- type II diabetes mellitus (~50% of groups: "CAD" and "Previous myocardial infarction")
- ≥ 1 myocardial infarction more than one year ago while taking daily aspirin ≥ 75 mg/d (group: "Previous myocardial infarction").
Key exclusion criteria (7 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
- intake of NSAIDs within 1 week of myocardial infarction (group: "Previous myocardial infarction").
- platelet count < 120 x 10^9/l
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 |
|---|---|---|
| acetylsalicylic acidAlso: Hjerdyl (Sandoz)75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin. | Drug | – |
Primary outcome
Platelet aggregation
Time frame: (at least) one hour after aspirin ingestion
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 10 Jun 2008.
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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.
Steen D Kristensen, M.D., DMSc principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetylsalicylic acid in people with Drug Resistance, 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 4 inclusion and 7 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 10 Jun 2008. 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?
Platelet aggregation (time frame: (at least) one hour after aspirin ingestion). 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 10 Jun 2008.