Trial Outcomes & Findings for Genetic Variation in Platelet Aggregation (NCT NCT01576536)
NCT ID: NCT01576536
Last Updated: 2019-06-05
Results Overview
EC50 represents the epinephrine concentration that produced 50% of maximal platelet aggregation (representing sensitivity to epinephrine) EC50 values were not normally distributed and were log-transformed for analyses.
COMPLETED
117 participants
at 6am and 930am
2019-06-05
Participant Flow
Healthy normotensive, non-smokers Caucasians and African-Americans aged 18-45 years were recruited via flyers and word of mouth from 2012-2015. No medications except oral contraceptives within two weeks and no antiplatelet medications within three weeks of the study. Women were studied in the first 14 days of their menstrual cycle.
Participant milestones
| Measure |
Healthy Volunteers
Normal healthy volunteers
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
117
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetic Variation in Platelet Aggregation
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=117 Participants
Normal healthy volunteers
|
|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6am and 930amPopulation: outcome data could not be collected on all subjects, since unable to draw enough blood at a particular timepoint
EC50 represents the epinephrine concentration that produced 50% of maximal platelet aggregation (representing sensitivity to epinephrine) EC50 values were not normally distributed and were log-transformed for analyses.
Outcome measures
| Measure |
Healthy Volunteers
n=108 Participants
Normal healthy volunteers
|
|---|---|
|
LogEC50 Platelet Aggregation
LogEC50 at 6am
|
2.65 nM
Standard Deviation 0.49
|
|
LogEC50 Platelet Aggregation
LogEC50 at 930am
|
2.62 nM
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: at 6am and 930amPopulation: some outcome data could not be collected for all subjects, unable to draw enough blood for a particular timepoint
Blood samples were taken from participants and centrifuged. Adenosine Diphosphate (ADP) at a fixed concentration of 2.5 uM was added. Agonist-induced platelet aggregation was expressed as the percentage aggregation after 6 minutes of stimulation.
Outcome measures
| Measure |
Healthy Volunteers
n=108 Participants
Normal healthy volunteers
|
|---|---|
|
Percentage, Adenosine Diphosphate (ADP) Induced Platelet Aggregation
% aggregation at 6am
|
72.8 percentage of aggregation
Standard Deviation 14.9
|
|
Percentage, Adenosine Diphosphate (ADP) Induced Platelet Aggregation
% aggregation at 930am
|
75.8 percentage of aggregation
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: at 6am and 930amPopulation: Some outcome date could not be collected for all subjects, unable to draw enough blood at a particular time point.
Blood samples were taken from participants and centrifuged. Collagen at a fixed concentration of 2.5 ug/ml was added. Agonist-induced platelet aggregation was expressed as the percentage aggregation after 6 minutes of stimulation.
Outcome measures
| Measure |
Healthy Volunteers
n=108 Participants
Normal healthy volunteers
|
|---|---|
|
Percentage, Collagen Induced Platelet Aggregation
% platelet aggregation at 930am
|
83.5 percentage of platelet aggregation
Standard Deviation 7.1
|
|
Percentage, Collagen Induced Platelet Aggregation
% platelet aggregation at 6am
|
84.3 percentage of platelet aggregation
Standard Deviation 7.9
|
Adverse Events
Healthy Volunteers
Serious adverse events
| Measure |
Healthy Volunteers
n=117 participants at risk
Normal healthy volunteers
|
|---|---|
|
General disorders
acute right groin pain
|
0.85%
1/117 • Number of events 1 • Adverse event data was collected from the time participant was admitted to the Clinical Research Center the evening before the study, to the end of the study, a 24 hour period.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place