Trial Outcomes & Findings for Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term (NCT NCT02697916)
NCT ID: NCT02697916
Last Updated: 2021-07-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15076 participants
Primary outcome timeframe
Time of randomization through study completion, approximately 4 years
Results posted on
2021-07-01
Participant Flow
Participant milestones
| Measure |
ASA 81mg
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Overall Study
STARTED
|
7540
|
7536
|
|
Overall Study
COMPLETED
|
6962
|
6828
|
|
Overall Study
NOT COMPLETED
|
578
|
708
|
Reasons for withdrawal
| Measure |
ASA 81mg
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Overall Study
Death
|
357
|
315
|
|
Overall Study
Withdrawal by Subject
|
221
|
393
|
Baseline Characteristics
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term
Baseline characteristics by cohort
| Measure |
ASA 81mg
n=7540 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7536 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
Total
n=15076 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
n=5 Participants
|
66.8 years
n=7 Participants
|
66.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2307 Participants
n=5 Participants
|
2417 Participants
n=7 Participants
|
4724 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5233 Participants
n=5 Participants
|
5119 Participants
n=7 Participants
|
10352 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
249 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6816 Participants
n=5 Participants
|
6737 Participants
n=7 Participants
|
13553 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
475 Participants
n=5 Participants
|
567 Participants
n=7 Participants
|
1042 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
69 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
82 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
664 Participants
n=5 Participants
|
647 Participants
n=7 Participants
|
1311 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6014 Participants
n=5 Participants
|
5976 Participants
n=7 Participants
|
11990 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
71 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
640 Participants
n=5 Participants
|
741 Participants
n=7 Participants
|
1381 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time of randomization through study completion, approximately 4 yearsOutcome measures
| Measure |
ASA 81mg
n=7434 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Number of Participants Experiencing All-cause Death, Hospitalization for Nonfatal MI, or Hospitalization for Nonfatal Stroke in High-risk Patients With a History of MI or Documented Atherosclerotic Cardiovascular Disease (ASCVD)
|
590 Participants
|
569 Participants
|
SECONDARY outcome
Timeframe: Time of randomization through study completion, approximately 4 yearsOutcome measures
| Measure |
ASA 81mg
n=7434 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Number of Participants Experiencing All-cause Death
|
315 Participants
|
357 Participants
|
SECONDARY outcome
Timeframe: Time of randomization through study completion, approximately 4 yearsOutcome measures
| Measure |
ASA 81mg
n=7434 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Number of Participants Experiencing Hospitalization for Nonfatal MI
|
228 Participants
|
213 Participants
|
SECONDARY outcome
Timeframe: Time of randomization through study completion, approximately 4 yearsOutcome measures
| Measure |
ASA 81mg
n=7434 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Number of Participants Experiencing Hospitalization for Nonfatal Stroke
|
102 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Time of randomization through study completion, approximately 4 yearsOutcome measures
| Measure |
ASA 81mg
n=7434 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG])
|
471 Participants
|
446 Participants
|
SECONDARY outcome
Timeframe: 2 yearsQuality of life measures are based on an ordinal scale from 1-5, where 1 corresponds to the best outcome and 5 to the worst. Model-based mean score estimates are obtained from mixed models of each quality of life measure.
Outcome measures
| Measure |
ASA 81mg
n=7540 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7536 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Quality of Life and Functional Status, as Measured on a 5-point Scale
Describe Current Health
|
2.77 score on a scale
Standard Error .011
|
2.8 score on a scale
Standard Error .011
|
|
Quality of Life and Functional Status, as Measured on a 5-point Scale
Able to Run Errands and Shop
|
1.65 score on a scale
Standard Error .011
|
1.66 score on a scale
Standard Error .012
|
|
Quality of Life and Functional Status, as Measured on a 5-point Scale
In the past 7 Days, Felt Depressed
|
1.69 score on a scale
Standard Error .010
|
1.7 score on a scale
Standard Error .011
|
|
Quality of Life and Functional Status, as Measured on a 5-point Scale
In the past 7 Days, Felt Fatigued
|
2.25 score on a scale
Standard Error .012
|
2.27 score on a scale
Standard Error .012
|
|
Quality of Life and Functional Status, as Measured on a 5-point Scale
In the past 7 Days, Problems with Sleep
|
2.06 score on a scale
Standard Error .012
|
2.10 score on a scale
Standard Error .012
|
|
Quality of Life and Functional Status, as Measured on a 5-point Scale
Trouble doing Regular Activities
|
1.84 score on a scale
Standard Error .012
|
1.88 score on a scale
Standard Error .012
|
|
Quality of Life and Functional Status, as Measured on a 5-point Scale
In the past 7 Days, Pain interfered
|
2.06 score on a scale
Standard Error .013
|
2.02 score on a scale
Standard Error .013
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of randomization through study completion, approximately 4 yearsOutcome measures
| Measure |
ASA 81mg
n=7434 Participants
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 Participants
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Number of Participants Experiencing Hospitalization for Major Bleeding Complications With an Associated Blood Product Transfusion
|
53 Participants
|
44 Participants
|
Adverse Events
ASA 81mg
Serious events: 383 serious events
Other events: 491 other events
Deaths: 315 deaths
ASA 325mg
Serious events: 349 serious events
Other events: 471 other events
Deaths: 357 deaths
Serious adverse events
| Measure |
ASA 81mg
n=7434 participants at risk
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 participants at risk
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Cardiac disorders
Non-Fatal MI
|
3.1%
228/7434 • Number of events 228 • Up to 50 months
|
2.9%
213/7330 • Number of events 213 • Up to 50 months
|
|
Vascular disorders
Non-Fatal Stroke
|
1.4%
102/7434 • Number of events 102 • Up to 50 months
|
1.3%
92/7330 • Number of events 92 • Up to 50 months
|
|
Cardiac disorders
Major Bleeding
|
0.71%
53/7434 • Number of events 53 • Up to 50 months
|
0.60%
44/7330 • Number of events 44 • Up to 50 months
|
Other adverse events
| Measure |
ASA 81mg
n=7434 participants at risk
aspirin 81mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
ASA 325mg
n=7330 participants at risk
aspirin 325mg
aspirin: 81mg of aspirin daily vs. 325mg of aspirin daily
|
|---|---|---|
|
Cardiac disorders
PCI or CABG
|
6.3%
471/7434 • Number of events 471 • Up to 50 months
|
6.1%
446/7330 • Number of events 446 • Up to 50 months
|
|
Cardiac disorders
Transient ischemia attack (TIA)
|
0.27%
20/7434 • Number of events 20 • Up to 50 months
|
0.34%
25/7330 • Number of events 25 • Up to 50 months
|
Additional Information
W. Schuyler Jones, MD
Duke University; Duke Clinical Research Institute
Phone: 919-668-8917
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place