Coronary Artery DiseaseEarly Phase 1NCT00753935
Aspirin Resistance in Coronary Artery Disease
A Early Phase 1 study testing enteric-coated aspirin and Chewable aspirin in people with Coronary Artery Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that certain patient characteristics associate with aspirin resistance. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- enteric-coated aspirin and Chewable aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2014
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On aspirin 81-325mg daily at time of enrollment
- Documented stable coronary artery disease or > 6 months after coronary artery bypass grafting or interventional cardiac procedure
- Written informed consent
Who cannot join
- Pre-menopausal female
- Renal disease (creatinine >= 2 mg/dl)
- Anemia (Hematocrit < 30%)
- Thrombocytopenia (platelet count < 135,000/ul)
- Use of NSAIDs or coxibs within the previous 2 weeks
- Concurrent use of other anti-platelet agents
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- Uncontrolled hypertension (systolic BP > 180 mmHg)
- Decompensated congestive heart failure
- Recent coronary syndrome (< 6 months)
- History of significant GI bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Aspirin Resistance at a Molecular Level in Aspirin-Treated Patients With Coronary Artery Disease
The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that certain patient characteristics associate with aspirin resistance. In addition, we will compare the effects of enteric-coated aspirin and chewable aspirin.
Read the detailed description
Aspirin is commonly used for its antithrombotic effects in patients at risk for cardiovascular events. Its primary mechanism of action is the irreversible acetylation of platelet cyclooxygenase-1, thereby inhibiting platelet production of thromboxane A2, a potent vasoconstrictor and activator of platelets. Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.
Previous studies have demonstrated that many patients have recurrent events despite treatment with aspirin, which has been termed "aspirin resistance" or "aspirin nonresponse." This study addresses some of the possible mechanisms for aspirin nonresponse; specifically, we will test the hypothesis that aspirin nonresponse results from states that produce high peroxide concentrations ("oxidative stress") in platelets. In addition, we will evaluate the effect of enteric coating on the pharmacologic efficacy of aspirin in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- enteric-coated aspirin, Chewable aspirin
- Keywords
- aspirin, aspirin resistance, aspirin nonresponse, cyclooxygenase, thromboxane, oxidative stress
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteric-coated aspirinDrug
Also called acetylsalicylic acid
enteric-coated aspirin 81mg daily for 2 weeks
Chewable aspirinDrug
Also called acetylsalicylic acid
chewable aspirin 81mg daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Enteric-coated aspirin | Experimental | patients received enteric-coated aspirin 81 mg qd for 2 weeks Receives: Drug: enteric-coated aspirin |
| Chewable aspirin | Active comparator | Patients received chewable aspirin 81 mg qd for 2 weeks Receives: Drug: Chewable aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Thromboxane B2
Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.
Measured: after 2 weeks on aspirin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startJun 2006
- Primary completionAug 2011
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, John Oates, Vanderbilt University
- Investigators
- Mary B Taylor, MD, MSCI, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753935
- Sponsor's protocol ID
- 040065
- Other IDs
- 5P50HL081009-03
- Status last verified
- Mar 2018
- First submitted
- 15 Sep 2008
- Last updated
- 19 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smith JP, Haddad EV, Taylor MB, Oram D, Blakemore D, Chen Q, Boutaud O, Oates JA. Suboptimal inhibition of platelet cyclooxygenase-1 by aspirin in metabolic syndrome. Hypertension. 2012 Mar;59(3):719-25. doi: 10.1161/HYPERTENSIONAHA.111.181404. Epub 2012 Feb 6.
PubMed 22311905
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aspirin Resistance at a Molecular Level in Aspirin-Treated Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00753935
- Acronym / sponsor ID
- 040065
- Conditions
- Coronary Artery Disease
- Keywords
- aspirin, aspirin resistance, aspirin nonresponse, cyclooxygenase, thromboxane, oxidative stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Sep 2008 (estimated)
- Results
- Posted 19 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that certain patient characteristics associate with aspirin resistance. In addition, we will compare the effects of enteric-coated aspirin and chewable aspirin.
Detailed description
Aspirin is commonly used for its antithrombotic effects in patients at risk for cardiovascular events. Its primary mechanism of action is the irreversible acetylation of platelet cyclooxygenase-1, thereby inhibiting platelet production of thromboxane A2, a potent vasoconstrictor and activator of platelets. Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.
Previous studies have demonstrated that many patients have recurrent events despite treatment with aspirin, which has been termed "aspirin resistance" or "aspirin nonresponse." This study addresses some of the possible mechanisms for aspirin nonresponse; specifically, we will test the hypothesis that aspirin nonresponse results from states that produce high peroxide concentrations ("oxidative stress") in platelets. In addition, we will evaluate the effect of enteric coating on the pharmacologic efficacy of aspirin in patients with coronary artery disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteric-coated aspirin | Experimental | Drug: enteric-coated aspirinpatients received enteric-coated aspirin 81 mg qd for 2 weeks |
| Chewable aspirin | Active comparator | Drug: Chewable aspirinPatients received chewable aspirin 81 mg qd for 2 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On aspirin 81-325mg daily at time of enrollment
- Documented stable coronary artery disease or > 6 months after coronary artery bypass grafting or interventional cardiac procedure
- Written informed consent
Key exclusion criteria (10 listed)
- Pre-menopausal female
- Renal disease (creatinine >= 2 mg/dl)
- Anemia (Hematocrit < 30%)
- Thrombocytopenia (platelet count < 135,000/ul)
- Use of NSAIDs or coxibs within the previous 2 weeks
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 |
|---|---|---|
| enteric-coated aspirinAlso: acetylsalicylic acidenteric-coated aspirin 81mg daily for 2 weeks | Drug | Enteric-coated aspirin |
| Chewable aspirinAlso: acetylsalicylic acidchewable aspirin 81mg daily for 2 weeks | Drug | Chewable aspirin |
Primary outcome
Change in Serum Thromboxane B2
Time frame: after 2 weeks on aspirin
Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22311905Smith JP, Haddad EV, Taylor MB, Oram D, Blakemore D, Chen Q, Boutaud O, Oates JA. Suboptimal inhibition of platelet cyclooxygenase-1 by aspirin in metabolic syndrome. Hypertension. 2012 Mar;59(3):719-25. doi: 10.1161/HYPERTENSIONAHA.111.181404. Epub 2012 Feb 6.
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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.
Mary B Taylor, MD, MSCI principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing enteric-coated aspirin and Chewable aspirin in people with Coronary Artery Disease, run by Vanderbilt University at 1 site in United States.
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 3 inclusion and 10 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 19 Apr 2018. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Serum Thromboxane B2 (time frame: after 2 weeks on aspirin). 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 NCT00753935, which also lists 1 linked publication.
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 19 Apr 2018.