Trial Outcomes & Findings for Novel Biomarkers of Thrombotic Risk (NCT NCT02505217)
NCT ID: NCT02505217
Last Updated: 2020-05-13
Results Overview
number of participants with myocardial infarction, stroke, and/or death
Recruitment status
COMPLETED
Target enrollment
200 participants
Primary outcome timeframe
average duration of follow-up 19 months
Results posted on
2020-05-13
Participant Flow
Participant milestones
| Measure |
Patients With MI and High FcGammaRIIa Expression
We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - high expression was \>11,000/platelet
|
Patients With MI and Low FcGammaRIIa Expression
We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - low expression was \<11,000/platelet
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
95
|
|
Overall Study
COMPLETED
|
104
|
93
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Patients With MI and High FcGammaRIIa Expression
We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - high expression was \>11,000/platelet
|
Patients With MI and Low FcGammaRIIa Expression
We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - low expression was \<11,000/platelet
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High FcγRIIa Expression
n=104 Participants
Patients with platelet expression of FcγRIIa \>11,000/platelet
|
Low FcγRIIa Expression
n=93 Participants
Patients with platelet expression of FcγRIIa \<11,000/platelet
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12 • n=104 Participants
|
61 years
STANDARD_DEVIATION 11 • n=93 Participants
|
63 years
STANDARD_DEVIATION 12 • n=197 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=104 Participants
|
27 Participants
n=93 Participants
|
58 Participants
n=197 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=104 Participants
|
66 Participants
n=93 Participants
|
139 Participants
n=197 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
104 participants
n=104 Participants
|
93 participants
n=93 Participants
|
197 participants
n=197 Participants
|
PRIMARY outcome
Timeframe: average duration of follow-up 19 monthsnumber of participants with myocardial infarction, stroke, and/or death
Outcome measures
| Measure |
High FcγRIIa Expression
n=104 Participants
Platelet FcγRIIa Expression \>11,000
|
Low FcγRIIa Expression
n=93 Participants
Platelet FcγRIIa Expression \<11,000
|
|---|---|---|
|
Cardiovascular Event - Myocardial Infarction, Stroke, Death
|
17 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearnumber of participants with the occurrence of a bleeding event leading the participant to seek medical attention
Outcome measures
| Measure |
High FcγRIIa Expression
n=104 Participants
Platelet FcγRIIa Expression \>11,000
|
Low FcγRIIa Expression
n=93 Participants
Platelet FcγRIIa Expression \<11,000
|
|---|---|---|
|
Bleeding
|
6 Participants
|
6 Participants
|
Adverse Events
Low Platelet Expression of FcGammaRIIa
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
High Platelet Expression of FcGammaRIIa
Serious events: 17 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Low Platelet Expression of FcGammaRIIa
n=93 participants at risk
Patients whose platelet expression of FcGammaRIIa was below 11,000
|
High Platelet Expression of FcGammaRIIa
n=104 participants at risk
Patients whose platelet expression of FcGammaRIIa was \> 11,000
|
|---|---|---|
|
Cardiac disorders
MI
|
3.2%
3/93 • average duration of follow-up 19 months
|
6.7%
7/104 • average duration of follow-up 19 months
|
|
Vascular disorders
stroke
|
0.00%
0/93 • average duration of follow-up 19 months
|
2.9%
3/104 • average duration of follow-up 19 months
|
|
Investigations
mortality
|
0.00%
0/93 • average duration of follow-up 19 months
|
2.9%
3/104 • average duration of follow-up 19 months
|
|
Cardiac disorders
revascularization
|
3.2%
3/93 • average duration of follow-up 19 months
|
3.8%
4/104 • average duration of follow-up 19 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place