Trial Outcomes & Findings for NSAIDs vs. Coxibs in the Presence of Aspirin (NCT NCT03699293)
NCT ID: NCT03699293
Last Updated: 2026-05-14
Results Overview
Percent change in AA-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of 4-week aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study. Each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods in a randomized crossover design. The primary analysis was performed within-subject, comparing platelet aggregation during celecoxib exposure versus naproxen exposure.
TERMINATED
PHASE4
8 participants
End of 4-week aspirin run-in period and after completion of each 4-week treatment period
2026-05-14
Participant Flow
Eight participants (8) completed a 4-week aspirin 81 mg daily run-in period prior to randomization. All participants were then randomized to one of two treatment sequences.
Participant milestones
| Measure |
Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice daily for 4 weeks and then naproxen sodium 550 mg twice daily for 4 weeks in a crossover design.
|
Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium , 3) ASA + Celecoxib
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks and then celecoxib 200 mg twice daily for 4 weeks in a crossover design.
|
|---|---|---|
|
Aspirin run-in (Baseline)
STARTED
|
4
|
4
|
|
Aspirin run-in (Baseline)
COMPLETED
|
3
|
3
|
|
Aspirin run-in (Baseline)
NOT COMPLETED
|
1
|
1
|
|
Treatment Period 1 (Post Randomization )
STARTED
|
3
|
3
|
|
Treatment Period 1 (Post Randomization )
COMPLETED
|
3
|
3
|
|
Treatment Period 1 (Post Randomization )
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (Crossover)
STARTED
|
3
|
3
|
|
Treatment Period 2 (Crossover)
COMPLETED
|
3
|
2
|
|
Treatment Period 2 (Crossover)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice daily for 4 weeks and then naproxen sodium 550 mg twice daily for 4 weeks in a crossover design.
|
Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium , 3) ASA + Celecoxib
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks and then celecoxib 200 mg twice daily for 4 weeks in a crossover design.
|
|---|---|---|
|
Aspirin run-in (Baseline)
Withdrawal by Subject
|
1
|
1
|
|
Treatment Period 2 (Crossover)
Adverse Event
|
0
|
1
|
Baseline Characteristics
no major differences between the groups
Baseline characteristics by cohort
| Measure |
Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice daily for 4 weeks and then naproxen sodium 550 mg twice daily for 4 weeks in a crossover design.
|
Sequence 2: 1) Aspirin Run in Period, 2) ASA +Sodium , 3) ASA + Celecoxib
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks and then celecoxib 200 mg twice daily for 4 weeks in a crossover design.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants • no major differences between the groups
|
0 Participants
n=504 Participants • no major differences between the groups
|
0 Participants
n=2016 Participants • no major differences between the groups
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=1512 Participants • no major differences between the groups
|
3 Participants
n=504 Participants • no major differences between the groups
|
6 Participants
n=2016 Participants • no major differences between the groups
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1512 Participants • no major differences between the groups
|
0 Participants
n=504 Participants • no major differences between the groups
|
0 Participants
n=2016 Participants • no major differences between the groups
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 38 • n=1512 Participants
|
56.0 years
STANDARD_DEVIATION 1.4 • n=504 Participants
|
45.4 years
STANDARD_DEVIATION 15.0 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment periodPopulation: One subject who was randomized to the ASA+ Naproxen Arm in the treatment period 1 was withdrawn due to adverse event
Percent change in AA-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of 4-week aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study. Each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods in a randomized crossover design. The primary analysis was performed within-subject, comparing platelet aggregation during celecoxib exposure versus naproxen exposure.
Outcome measures
| Measure |
Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice daily for 4 weeks and then naproxen sodium 550 mg twice daily for 4 weeks in a crossover design.
|
Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium, 3) ASA + Celecoxib
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks and then celecoxib 200 mg twice daily for 4 weeks in a crossover design.
|
|---|---|---|
|
Change in Arachidonic Acid (AA)-Induced Platelet Aggregation
End of 4-week aspirin (run in period)
|
2.5 Percent Aggregation (%)
Standard Deviation 0.7
|
3.3 Percent Aggregation (%)
Standard Deviation 4.9
|
|
Change in Arachidonic Acid (AA)-Induced Platelet Aggregation
End of Treatment period 1 (post randomization)
|
1.4 Percent Aggregation (%)
Standard Deviation 1.6
|
3 Percent Aggregation (%)
Standard Deviation 0
|
|
Change in Arachidonic Acid (AA)-Induced Platelet Aggregation
End of Treatment period 2(Crossover)
|
6.5 Percent Aggregation (%)
Standard Deviation 7.8
|
31.5 Percent Aggregation (%)
Standard Deviation 34.6
|
PRIMARY outcome
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment periodPopulation: One subject who was randomized to the ASA+ Naproxen Arm in the treatment period 1 was withdrawn due to adverse event
Percent change in collagen-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was continued throughout the study. Each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods in a randomized crossover design. The primary analysis compared within-subject differences between celecoxib and naproxen exposure periods.
Outcome measures
| Measure |
Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice daily for 4 weeks and then naproxen sodium 550 mg twice daily for 4 weeks in a crossover design.
|
Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium, 3) ASA + Celecoxib
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks and then celecoxib 200 mg twice daily for 4 weeks in a crossover design.
|
|---|---|---|
|
Change in Collagen-induced Platelet Aggregation (%)
Aspirin run-in period
|
55.3 Percent Aggregation (%)
Standard Deviation 20.4
|
68.0 Percent Aggregation (%)
Standard Deviation 18.4
|
|
Change in Collagen-induced Platelet Aggregation (%)
End of Treatment Period 1( post randomization)
|
-0.3 Percent Aggregation (%)
Standard Deviation 3.7
|
-12.5 Percent Aggregation (%)
Standard Deviation 14.8
|
|
Change in Collagen-induced Platelet Aggregation (%)
End of Treatment Period 2 ( Crossover)
|
-10.7 Percent Aggregation (%)
Standard Deviation 8.2
|
-6 Percent Aggregation (%)
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.Population: One subject who was randomized to the ASA+ Naproxen Arm in the treatment period 1 was withdrawn due to adverse event
Percent change in ADP-induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of 4-week aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study. This was a randomized crossover study in which each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods. The primary analysis compared within-subject differences in platelet aggregation between celecoxib exposure and naproxen exposure periods.
Outcome measures
| Measure |
Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice daily for 4 weeks and then naproxen sodium 550 mg twice daily for 4 weeks in a crossover design.
|
Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium, 3) ASA + Celecoxib
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks and then celecoxib 200 mg twice daily for 4 weeks in a crossover design.
|
|---|---|---|
|
Change in Adenosine Diphosphate (ADP)-Induced Platelet Aggregation (%)
Aspirin Run in Period
|
60.3 Percent Aggregation (%)
Standard Deviation 11.0
|
64.0 Percent Aggregation (%)
Standard Deviation 14.4
|
|
Change in Adenosine Diphosphate (ADP)-Induced Platelet Aggregation (%)
End of Treatment period 1 (Post randomization)
|
-27 Percent Aggregation (%)
Standard Deviation 22
|
0.5 Percent Aggregation (%)
Standard Deviation 0.7
|
|
Change in Adenosine Diphosphate (ADP)-Induced Platelet Aggregation (%)
End of Treatment period 2 (Crossover)
|
-6.6 Percent Aggregation (%)
Standard Deviation 6.7
|
-3 Percent Aggregation (%)
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: End of 4-week aspirin run-in period and after completion of each 4-week treatment period.Population: One subject who was randomized to the ASA+ Naproxen Arm in the treatment period 1 was withdrawn due to adverse event
Percent change in epinephrine induced platelet aggregation measured by light transmission aggregometry in platelet-rich plasma. Measurements were obtained at: * End of 4-week aspirin 81 mg daily run-in period (baseline) * After completion of the first 4-week treatment period following randomization * After completion of the second 4-week treatment period (crossover period) Aspirin 81 mg daily was administered during the run-in period and continued throughout the study. This was a randomized crossover study in which each participant received celecoxib (200 mg twice daily) and naproxen sodium (550 mg twice daily) in two separate treatment periods. The primary analysis compared within-subject differences in platelet aggregation between celecoxib exposure and naproxen exposure periods.
Outcome measures
| Measure |
Sequence 1: 1) Aspirin Run in Period, 2) ASA + Celecoxib, 3) ASA + Naproxen Sodium
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice daily for 4 weeks and then naproxen sodium 550 mg twice daily for 4 weeks in a crossover design.
|
Sequence 2: 1) Aspirin Run in Period, 2) ASA + Naproxen Sodium, 3) ASA + Celecoxib
n=3 Participants
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and will continue aspirin throughout the study. Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks and then celecoxib 200 mg twice daily for 4 weeks in a crossover design.
|
|---|---|---|
|
Change in Epinephrine-induced Platelet Aggregation (%)
Aspirin run-in period
|
23.3 Percent Aggregation (%)
Standard Deviation 6.8
|
10.5 Percent Aggregation (%)
Standard Deviation 3.5
|
|
Change in Epinephrine-induced Platelet Aggregation (%)
End of Treatment 1 (Post randomization)
|
5.3 Percent Aggregation (%)
Standard Deviation 3.0
|
2.5 Percent Aggregation (%)
Standard Deviation 3.5
|
|
Change in Epinephrine-induced Platelet Aggregation (%)
End of Treatment 2 (Crossover)
|
36.0 Percent Aggregation (%)
Standard Deviation 21.2
|
19.5 Percent Aggregation (%)
Standard Deviation 20.0
|
Adverse Events
Aspirin Run in Period
ASA + Celecoxib Treatment Period
ASA + Naproxen Sodium Treatment Period
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aspirin Run in Period
n=8 participants at risk
All participants will receive aspirin 81 mg once daily during a 4-week run-in period and throughout the study
|
ASA + Celecoxib Treatment Period
n=6 participants at risk
Following randomization, participants assigned to this sequence will receive celecoxib 200 mg twice
|
ASA + Naproxen Sodium Treatment Period
n=6 participants at risk
Following randomization, participants assigned to this sequence will receive naproxen sodium 550 mg twice daily for 4 weeks, in addition to Aspirin
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal indigestion
|
0.00%
0/8 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
0.00%
0/6 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
16.7%
1/6 • Number of events 1 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
|
Gastrointestinal disorders
Acute Gastritis [1]
|
0.00%
0/8 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
0.00%
0/6 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
16.7%
1/6 • Number of events 1 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
|
Nervous system disorders
Carpal tunnel syndrome [1]
|
0.00%
0/8 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
0.00%
0/6 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
16.7%
1/6 • Number of events 1 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
|
Reproductive system and breast disorders
Vaginal pain [1]
|
0.00%
0/8 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
0.00%
0/6 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
16.7%
1/6 • Number of events 1 • 12 weeks from enrollment
Aspirin, naproxen, and celecoxib have been extensively studied and each drug's overall adverse event profile has been well described. For the purpose of this trial, All SAEs, AEs which are not serious but which lead to permanent discontinuation of study medication, and AEs necessitating subject withdrawal will be captured
|
Additional Information
Director of Clinical Trials
Sinai Center for Thrombosis Research and Drug Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place