Trial Outcomes & Findings for Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation (NCT NCT01066923)
NCT ID: NCT01066923
Last Updated: 2017-11-13
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
0, 30, 60, and 90 minutes post exercise
Results posted on
2017-11-13
Participant Flow
Active Cooling Arm not completed - insufficient number of subjects were recruited to complete these arms of the trial, and the Passive Cooling arms were the only ones conducted.
Participant milestones
| Measure |
Daily ASA, Passive Cool, Acute ASA
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
|
Daily ASA, Passive Cool, Acute Placebo
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy
|
Daily Placebo, Passive Cool, Acute ASA
Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
|
Daily Placebo, Passive Cool, Acute Placebo
Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
32
|
33
|
31
|
|
Overall Study
Platelet Closure Time
|
25
|
29
|
25
|
23
|
|
Overall Study
Vascular Function
|
13
|
14
|
12
|
13
|
|
Overall Study
Activation of Coagulation
|
0
|
0
|
0
|
0
|
|
Overall Study
Retinal Imaging
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
25
|
29
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
8
|
8
|
Reasons for withdrawal
| Measure |
Daily ASA, Passive Cool, Acute ASA
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
|
Daily ASA, Passive Cool, Acute Placebo
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy
|
Daily Placebo, Passive Cool, Acute ASA
Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
|
Daily Placebo, Passive Cool, Acute Placebo
Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
8
|
8
|
Baseline Characteristics
Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation
Baseline characteristics by cohort
| Measure |
Daily ASA, Passive Cool, Acute ASA
n=25 Participants
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
|
Daily ASA, Passive Cool, Acute Placebo
n=29 Participants
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy
|
Daily Placebo, Passive Cool, Acute ASA
n=25 Participants
Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
|
Daily Placebo, Passive Cool, Acute Placebo
n=23 Participants
Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
29.3 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
30.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
31.8 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
29 participants
n=7 Participants
|
25 participants
n=5 Participants
|
23 participants
n=4 Participants
|
102 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0, 30, 60, and 90 minutes post exerciseOutcome measures
| Measure |
Daily ASA, Passive Cool, Acute ASA
n=25 Participants
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
|
Daily ASA, Passive Cool, Acute Placebo
n=29 Participants
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy
|
Daily Placebo, Passive Cool, Acute ASA
n=25 Participants
Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
|
Daily Placebo, Passive Cool, Acute Placebo
n=23 Participants
Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy
|
|---|---|---|---|---|
|
Platelet Closure Time
Immediate post exercise
|
275.5 seconds
Interval 62.0 to 300.0
|
207 seconds
Interval 55.0 to 300.0
|
95 seconds
Interval 71.0 to 182.0
|
90 seconds
Interval 58.0 to 201.0
|
|
Platelet Closure Time
30 minutes post
|
300 seconds
Interval 300.0 to 300.0
|
300 seconds
Interval 150.0 to 300.0
|
300 seconds
Interval 110.0 to 300.0
|
105 seconds
Interval 80.0 to 120.0
|
|
Platelet Closure Time
60 minutes post
|
300 seconds
Interval 300.0 to 300.0
|
300 seconds
Interval 120.0 to 300.0
|
300 seconds
Interval 125.0 to 300.0
|
105 seconds
Interval 80.0 to 120.0
|
|
Platelet Closure Time
90 minutes post
|
300 seconds
Interval 300.0 to 300.0
|
275 seconds
Interval 120.0 to 300.0
|
300 seconds
Interval 150.0 to 300.0
|
105 seconds
Interval 80.0 to 120.0
|
PRIMARY outcome
Timeframe: Baseline, 30, 60, and 90 minutes post exerciseReactive Hyperemia Index
Outcome measures
| Measure |
Daily ASA, Passive Cool, Acute ASA
n=13 Participants
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
|
Daily ASA, Passive Cool, Acute Placebo
n=14 Participants
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling: Removing protective garments for passive cooling following exercise
Acute placebo: Placebo comparator for acute aspirin therapy
|
Daily Placebo, Passive Cool, Acute ASA
n=12 Participants
Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
|
Daily Placebo, Passive Cool, Acute Placebo
n=13 Participants
Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling: Removing protective garments for passive cooling following exercise
Daily placebo: Placebo comparator for daily aspirin therapy
Acute placebo: Placebo comparator for acute aspirin therapy
|
|---|---|---|---|---|
|
Vascular Function Measured by Peripheral Arterial Tonometry
Baseline
|
1.89 ratio (Reactive Hyperemia Index)
Standard Deviation 0.38
|
1.77 ratio (Reactive Hyperemia Index)
Standard Deviation 0.51
|
2.16 ratio (Reactive Hyperemia Index)
Standard Deviation 0.74
|
1.72 ratio (Reactive Hyperemia Index)
Standard Deviation 0.34
|
|
Vascular Function Measured by Peripheral Arterial Tonometry
30 minutes post
|
1.97 ratio (Reactive Hyperemia Index)
Standard Deviation 0.56
|
1.77 ratio (Reactive Hyperemia Index)
Standard Deviation 0.38
|
1.77 ratio (Reactive Hyperemia Index)
Standard Deviation 0.71
|
1.73 ratio (Reactive Hyperemia Index)
Standard Deviation 0.30
|
|
Vascular Function Measured by Peripheral Arterial Tonometry
60 minutes post
|
2.18 ratio (Reactive Hyperemia Index)
Standard Deviation 0.48
|
1.92 ratio (Reactive Hyperemia Index)
Standard Deviation 0.48
|
1.56 ratio (Reactive Hyperemia Index)
Standard Deviation 0.68
|
1.83 ratio (Reactive Hyperemia Index)
Standard Deviation 0.40
|
|
Vascular Function Measured by Peripheral Arterial Tonometry
90 minutes post
|
2.09 ratio (Reactive Hyperemia Index)
Standard Deviation 0.31
|
1.98 ratio (Reactive Hyperemia Index)
Standard Deviation 0.45
|
1.91 ratio (Reactive Hyperemia Index)
Standard Deviation 0.66
|
1.98 ratio (Reactive Hyperemia Index)
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 0, 30, 60, and 90 minutes post exercisePopulation: This measure was not collected. Equipment was not available.
This measure was not collected. Equipment was not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 30, 60, and 90 minutes post exercisePopulation: This measure was not collected. Equipment was not available.
This measure was not collected. Equipment was not available.
Outcome measures
Outcome data not reported
Adverse Events
Daily ASA, Passive Cool, Acute ASA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daily ASA, Passive Cool, Acute Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daily Placebo, Passive Cool, Acute ASA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daily Placebo, Passive Cool, Acute Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place