Trial Outcomes & Findings for Platelet Activity in Vascular Surgery and Cardiovascular Events (NCT NCT02106429)
NCT ID: NCT02106429
Last Updated: 2024-08-20
Results Overview
To determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in Peripheral artery disease (PAD) patients undergoing open non-emergent lower extremity vascular intervention. We will characterize the platelet phenotype in 350 PAD patients before vascular surgery and use Cox proportional hazard models to determine the independent association of the platelet phenotype with risk of cardiovascular events in the first 30 days after surgery.
COMPLETED
246 participants
30-days
2024-08-20
Participant Flow
Participant milestones
| Measure |
Platelet Hyperactivity
Subjects with platelet hyperactivity undergoing non emergent lower extremity revascularization.
|
No Platelet Hyperactivity
Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
43
|
|
Overall Study
COMPLETED
|
203
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Platelet Activity in Vascular Surgery and Cardiovascular Events
Baseline characteristics by cohort
| Measure |
Platelet Hyperactivity
n=203 Participants
Subjects with platelet hyperactivity undergoing non emergent lower extremity revascularization.
|
No Platelet Hyperactivity
n=43 Participants
Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.04 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
69.79 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
69.89 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
203 participants
n=99 Participants
|
43 participants
n=107 Participants
|
246 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30-daysTo determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in Peripheral artery disease (PAD) patients undergoing open non-emergent lower extremity vascular intervention. We will characterize the platelet phenotype in 350 PAD patients before vascular surgery and use Cox proportional hazard models to determine the independent association of the platelet phenotype with risk of cardiovascular events in the first 30 days after surgery.
Outcome measures
| Measure |
Platelet Hyperactivity
n=203 Participants
Subjects with platelet hyperactivity undergoing non emergent lower extremity revascularization.
|
No Platelet Hyperactivity
n=43 Participants
Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization.
|
|---|---|---|
|
Number of Patients in Which Platelet Activity Measurements Were Associated With Short-term Cardiovascular Events
|
31 participants
|
16 participants
|
Adverse Events
Platelet Hyperactivity
No Platelet Hyperactivity
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