Cardiovascular Risk FactorPhase 4NCT01276691
Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
A Phase 4 study testing 81 mg enteric coated aspirin in people with Cardiovascular Risk Factor and C.Medical Procedure; Vascular, Functional or Late, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The investigators hypothesize that 1. an acute treatment of low-dose aspirin will lead to a) decreased resting platelet activation, platelet aggregation, and clotting potential, b) increased fibrinolytic potential following fire fighting, c) no significant effect on endothelial function or arterial stiffness versus… Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, C.Medical Procedure; Vascular, Functional or Late, Electrolyte and Fluid Balance Conditions
- What is being tested?
- 81 mg enteric coated aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2012
- Phase
- Phase 4
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male firefighters (career and volunteer), medically cleared by home fire department.
- Ages 40 - 60
- Completion of a yearly period medical evaluation based on NFPA 1582 within the past 12 months or an evaluation by an occupational medical group through this study.
Who cannot join
- Over 60 or under 40 years of age.
- Not a firefighter.
- Individuals at risk for developing gastrointestinal (GI) complications while on aspirin therapy due to a combination of the following: smoking; concurrent NSAID, steroid, Clopidogrel, or Warfarin therapy; history of upper GI complications; history of renal impairment; history of elevated serum creatinine; hypertension; and cardiac failure.
- Individuals with cases of allergy or asthma, intolerance, and recurrent vascular events.
- Individuals taking statins.
- Individuals who are currently taking aspiring regularly.
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Fire Service Institute
Champaign, Illinois, 61820
About this study
The investigators hypothesize that
- an acute treatment of low-dose aspirin will lead to a) decreased resting platelet activation, platelet aggregation, and clotting potential, b) increased fibrinolytic potential following fire fighting, c) no significant effect on endothelial function or arterial stiffness versus the placebo condition.
- chronic treatment with low-dose aspirin will lead to a) decreased resting and fire fighting induced platelet activation, platelet aggregation, clotting potential, b) increased fibrinolytic potential, and c) increased endothelial function and decreased arterial stiffness in response to live fire fighting versus the placebo condition.
- short-term fire fighting activity will result in: a) a reduction in arterial function (reduced endothelial function, increased augmentation index and an attenuated arterial stiffness response); b) a disruption in hemostasis that is characterized by an increase in platelet number and function, an increased coagulatory potential and altered fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic inflammation, monokine chemoattractant protein, and matrix metalloproteinases.
- Conditions
- Cardiovascular Risk Factor, C.Medical Procedure; Vascular, Functional or Late, Electrolyte and Fluid Balance Conditions
- Being tested
- 81 mg enteric coated aspirin
- Keywords
- Vascular function, Inflammation, Oxidative stress, Hemostatic balance, Aspirin, Firefighting
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
81 mg enteric coated aspirinDrug
Also called aspirin
81 mg enteric coated aspirin will be provided both as an acute dosage immediately prior to firefighting (1 hour pre-activity) and as a 14 day dosage prior to firefighting
| Study group | Role | What they receive |
|---|---|---|
| Acute, Aspirin | Active comparator | 81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage Receives: Drug: 81 mg enteric coated aspirin |
| Acute, Placebo | Placebo comparator | Acute single dosage of placebo provided 30 minutes prior to firefighting Receives: Drug: 81 mg enteric coated aspirin |
| Chronic, Aspirin | Active comparator | 81 mg asprin provided prior to firefighting- 14 day dosage Receives: Drug: 81 mg enteric coated aspirin |
| Chronic, Placebo | Placebo comparator | 14 day dosage of placebo provided prior to firefighting Receives: Drug: 81 mg enteric coated aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
Vascular function will be assessed via pulse wave analysis, pulse wave velocity, carotid artery compliance, beta stiffness index, forearm rsistance artery vasodilatory capacity, and brachial artery blood flow.
Measured: Less than 60 minutes before initiating firefighting activity
Hemostatic balance
Blood samples will be collected by a trained phlebotomist from the antecubital vein directly into vacutainers with little or no stasis using a 21-gauge needle. Samples will be used to quantify platetlet number and function, fibrinogen, prothrombin and partial thromboplastin time, t-PA and PAI-1 activities and antigen
Measured: Less than 60 minutes before initiating firefighting activity
Inflammatory and Oxidative Stress markers
CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin
Measured: Less than 60 minutes before initiating firefighting activity
Vascular function
Vascular function will be assessed via pulse wave analysis, pulse wave velocity, carotid artery compliance, beta stiffness index, forearm rsistance artery vasodilatory capacity, and brachial artery blood flow.
Measured: Less than 60 minutes after completing 20 minutes of firefighting activity
Hemostatic balance
Blood samples will be collected by a trained phlebotomist from the antecubital vein directly into vacutainers with little or no stasis using a 21-gauge needle. Samples will be used to quantify platetlet number and function, fibrinogen, prothrombin and partial thromboplastin time, t-PA and PAI-1 activities and antigen
Measured: Less than 60 minutes after completing 20 minutes of firefighting activity
Inflammatory and Oxidative Stress markers
CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin
Measured: Less than 60 minutes after completing 20 minutes of firefighting activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Responsible party
- Principal investigator, Gavin Horn, University of Illinois at Urbana-Champaign
- Investigators
- Gavin P Horn, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276691
- Sponsor's protocol ID
- AsprinFire2011
- Status last verified
- Jul 2020
- First submitted
- 10 Jan 2011
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith DL, Friedman NMG, Bloom SI, Armero WL, Pence BD, Cook MD, Fernhall B, Horn GP, Woods J. Firefighting Induces Acute Inflammatory Responses that are not Relieved by Aspirin in Older Firefighters. J Occup Environ Med. 2019 Jul;61(7):617-622. doi: 10.1097/JOM.0000000000001626.
PubMed 31090673Lane-Cordova AD, Ranadive SM, Yan H, Kappus RM, Sun P, Bunsawat K, Smith DL, Horn GP, Ploutz-Snyder R, Fernhall BO. Effect of Aspirin Supplementation on Hemodynamics in Older Firefighters. Med Sci Sports Exerc. 2015 Dec;47(12):2653-9. doi: 10.1249/MSS.0000000000000713.
PubMed 26057939
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
- ClinicalTrials.gov ID
- NCT01276691
- Acronym / sponsor ID
- AsprinFire2011
- Conditions
- Cardiovascular Risk Factor, C.Medical Procedure; Vascular, Functional or Late, Electrolyte and Fluid Balance Conditions
- Keywords
- Vascular function, Inflammation, Oxidative stress, Hemostatic balance, Aspirin, Firefighting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jan 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.
The investigators hypothesize that
- an acute treatment of low-dose aspirin will lead to a) decreased resting platelet activation, platelet aggregation, and clotting potential, b) increased fibrinolytic potential following fire fighting, c) no significant effect on endothelial function or arterial stiffness versus the placebo condition.
- chronic treatment with low-dose aspirin will lead to a) decreased resting and fire fighting induced platelet activation, platelet aggregation, clotting potential, b) increased fibrinolytic potential, and c) increased endothelial function and decreased arterial stiffness in response to live fire fighting versus the placebo condition.
- short-term fire fighting activity will result in: a) a reduction in arterial function (reduced endothelial function, increased augmentation index and an attenuated arterial stiffness response); b) a disruption in hemostasis that is characterized by an increase in platelet number and function, an increased coagulatory potential and altered fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic inflammation, monokine chemoattractant protein, and matrix metalloproteinases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute, Aspirin | Active comparator | Drug: 81 mg enteric coated aspirin81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage |
| Acute, Placebo | Placebo comparator | Drug: 81 mg enteric coated aspirinAcute single dosage of placebo provided 30 minutes prior to firefighting |
| Chronic, Aspirin | Active comparator | Drug: 81 mg enteric coated aspirin81 mg asprin provided prior to firefighting- 14 day dosage |
| Chronic, Placebo | Placebo comparator | Drug: 81 mg enteric coated aspirin14 day dosage of placebo provided prior to firefighting |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male firefighters (career and volunteer), medically cleared by home fire department.
- Ages 40 - 60
- Completion of a yearly period medical evaluation based on NFPA 1582 within the past 12 months or an evaluation by an occupational medical group through this study.
Key exclusion criteria (6 listed)
- Over 60 or under 40 years of age.
- Not a firefighter.
- Individuals at risk for developing gastrointestinal (GI) complications while on aspirin therapy due to a combination of the following: smoking; concurrent NSAID, steroid, Clopidogrel, or Warfarin therapy; history of upper GI complications; history of renal impairment; history of elevated serum creatinine; hypertension; and cardiac failure.
- Individuals with cases of allergy or asthma, intolerance, and recurrent vascular events.
- Individuals taking statins.
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 |
|---|---|---|
| 81 mg enteric coated aspirinAlso: aspirin81 mg enteric coated aspirin will be provided both as an acute dosage immediately prior to firefighting (1 hour pre-activity) and as a 14 day dosage prior to firefighting | Drug | Acute, Aspirin, Acute, Placebo, Chronic, Aspirin, Chronic, Placebo |
Primary outcome
Vascular function
Time frame: Less than 60 minutes before initiating firefighting activity
Vascular function will be assessed via pulse wave analysis, pulse wave velocity, carotid artery compliance, beta stiffness index, forearm rsistance artery vasodilatory capacity, and brachial artery blood flow.
Hemostatic balance
Time frame: Less than 60 minutes before initiating firefighting activity
Blood samples will be collected by a trained phlebotomist from the antecubital vein directly into vacutainers with little or no stasis using a 21-gauge needle. Samples will be used to quantify platetlet number and function, fibrinogen, prothrombin and partial thromboplastin time, t-PA and PAI-1 activities and antigen
Inflammatory and Oxidative Stress markers
Time frame: Less than 60 minutes before initiating firefighting activity
CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin
Vascular function
Time frame: Less than 60 minutes after completing 20 minutes of firefighting activity
Vascular function will be assessed via pulse wave analysis, pulse wave velocity, carotid artery compliance, beta stiffness index, forearm rsistance artery vasodilatory capacity, and brachial artery blood flow.
Hemostatic balance
Time frame: Less than 60 minutes after completing 20 minutes of firefighting activity
Blood samples will be collected by a trained phlebotomist from the antecubital vein directly into vacutainers with little or no stasis using a 21-gauge needle. Samples will be used to quantify platetlet number and function, fibrinogen, prothrombin and partial thromboplastin time, t-PA and PAI-1 activities and antigen
Inflammatory and Oxidative Stress markers
Time frame: Less than 60 minutes after completing 20 minutes of firefighting activity
CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin
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 21 Jul 2020.
- Derived from this study: PubMed 31090673Smith DL, Friedman NMG, Bloom SI, Armero WL, Pence BD, Cook MD, Fernhall B, Horn GP, Woods J. Firefighting Induces Acute Inflammatory Responses that are not Relieved by Aspirin in Older Firefighters. J Occup Environ Med. 2019 Jul;61(7):617-622. doi: 10.1097/JOM.0000000000001626.
- Derived from this study: PubMed 26057939Lane-Cordova AD, Ranadive SM, Yan H, Kappus RM, Sun P, Bunsawat K, Smith DL, Horn GP, Ploutz-Snyder R, Fernhall BO. Effect of Aspirin Supplementation on Hemodynamics in Older Firefighters. Med Sci Sports Exerc. 2015 Dec;47(12):2653-9. doi: 10.1249/MSS.0000000000000713.
- Illinois Fire Service Institute home pageLink provided by the sponsor.
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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.
Gavin P Horn, PhD principal investigator
University of Illinois Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 81 mg enteric coated aspirin in people with Cardiovascular Risk Factor and C.Medical Procedure; Vascular, Functional or Late, run by University of Illinois at Urbana-Champaign 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 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: finished, as of the sponsor's last update on 21 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vascular function (time frame: Less than 60 minutes before initiating firefighting activity). The study lists 6 primary outcomes in all. 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 NCT01276691, which also lists 2 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 21 Jul 2020.