Trial Outcomes & Findings for Aspirin Resistance and Stroke Risk: Platelet Function Analysis in Patients With Ischemic Events (NCT NCT01586975)
NCT ID: NCT01586975
Last Updated: 2015-12-31
Results Overview
Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as \<172 seconds."
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
93 participants
Primary outcome timeframe
3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)
Results posted on
2015-12-31
Participant Flow
Patients with cerebrovascular disease and taking one or more antiplatelet medication were consented for study participation from 2007 though 2010. Patients were recruiting on the inpatient stroke unit at Northwestern Memorial Hospital and seen in the outpatient stroke clinic.
Participant milestones
| Measure |
Clopidogrel 75 mg
Clopidogrel 75 mg QD
|
Aspirin 81 mg
Aspirin 81 mg QD
|
Aspirin > 300 mg
Aspiring \> 300 mg QD
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
32
|
46
|
|
Overall Study
COMPLETED
|
15
|
32
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aspirin Resistance and Stroke Risk: Platelet Function Analysis in Patients With Ischemic Events
Baseline characteristics by cohort
| Measure |
Clopidogrel 75 mg
n=15 Participants
Clopidogrel 75 mg QD
|
Aspirin 81 mg
n=32 Participants
Aspirin 81 mg QD
|
Aspiring >300 mg
n=46 Participants
Aspirin \>300 mg QD
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
60.6 years
n=5 Participants
|
67.4 years
n=7 Participants
|
56.2 years
n=5 Participants
|
60.7 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
32 participants
n=7 Participants
|
46 participants
n=5 Participants
|
93 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as \<172 seconds."
Outcome measures
| Measure |
Clopidogrel 75 mg
n=15 Participants
Clopidogrel 75 mg QD
|
Aspirin 81 mg
n=32 Participants
open label Aspirin
|
Aspirin > 300 mg
n=46 Participants
open-label Aspirin
|
|---|---|---|---|
|
PFA1
|
202.0 seconds
Standard Error 27.1
|
271.1 seconds
Standard Error 14.9
|
234.7 seconds
Standard Error 13.4
|
Adverse Events
Clopidogrel 75 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Aspirin 81 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Aspirin >300 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clopidogrel 75 mg
n=15 participants at risk
Clopidogrel 75 mg QD
|
Aspirin 81 mg
n=32 participants at risk
Aspirin 81 mg QD
|
Aspirin >300 mg
n=46 participants at risk
Aspirin \>300 mg QD
|
|---|---|---|---|
|
Vascular disorders
Clinical Stroke
|
0.00%
0/15 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
3.1%
1/32 • Number of events 1 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
0.00%
0/46 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
|
Cardiac disorders
MI
|
0.00%
0/15 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
0.00%
0/32 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
2.2%
1/46 • Number of events 1 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
|
Vascular disorders
TIA
|
0.00%
0/15 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
0.00%
0/32 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
2.2%
1/46 • Number of events 1 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
Other adverse events
| Measure |
Clopidogrel 75 mg
n=15 participants at risk
Clopidogrel 75 mg QD
|
Aspirin 81 mg
n=32 participants at risk
Aspirin 81 mg QD
|
Aspirin >300 mg
n=46 participants at risk
Aspirin \>300 mg QD
|
|---|---|---|---|
|
Vascular disorders
Nose bleeds
|
0.00%
0/15 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
6.2%
2/32 • Number of events 2 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
4.3%
2/46 • Number of events 2 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
|
Immune system disorders
Bruising
|
6.7%
1/15 • Number of events 1 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
0.00%
0/32 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
0.00%
0/46 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
|
Gastrointestinal disorders
GI bleeding
|
6.7%
1/15 • Number of events 1 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
3.1%
1/32 • Number of events 1 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
0.00%
0/46 • Patients were monitored via routine clinic/office visits to determine if they had an ischemic vascular event or hemorrhagic event. These follow-up visits were scheduled every 3-6 months as per their regularly scheduled clinic follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place