NCT01276691

Brief Summary

The investigators hypothesize that

  1. 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 the placebo condition.
  2. 2.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.
  3. 3.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

January 10, 2011

Last Update Submit

July 17, 2020

Conditions

Cardiovascular Risk FactorC.Medical Procedure; Vascular, Functional or LateElectrolyte and Fluid Balance Conditions

Keywords

Vascular functionInflammationOxidative stressHemostatic balanceAspirinFirefighting

Outcome Measures

Primary Outcomes (6)

  • 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.

    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

    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

    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.

    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

    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

    Less than 60 minutes after completing 20 minutes of firefighting activity

Study Arms (4)

Acute, Aspirin

ACTIVE COMPARATOR

81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage

Drug: 81 mg enteric coated aspirin

Acute, Placebo

PLACEBO COMPARATOR

Acute single dosage of placebo provided 30 minutes prior to firefighting

Drug: 81 mg enteric coated aspirin

Chronic, Aspirin

ACTIVE COMPARATOR

81 mg asprin provided prior to firefighting- 14 day dosage

Drug: 81 mg enteric coated aspirin

Chronic, Placebo

PLACEBO COMPARATOR

14 day dosage of placebo provided prior to firefighting

Drug: 81 mg enteric coated aspirin

Interventions

81 mg enteric coated aspirinDRUG

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

Also known as: aspirin
Acute, AspirinAcute, PlaceboChronic, AspirinChronic, Placebo

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Fire Service Institute

Champaign, Illinois, 61820, United States

Location

Related Publications (2)

  • 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.

    PMID: 31090673DERIVED

  • Lane-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.

    PMID: 26057939DERIVED

Related Links

MeSH Terms

Conditions

Inflammation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gavin P Horn, PhD

    University of Illinois Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 13, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

July 21, 2020

Record last verified: 2020-07

Locations

US(1)