Trial Outcomes & Findings for Platelet Inhibition in Patients With Systolic Heart Failure (NCT NCT01765400)
NCT ID: NCT01765400
Last Updated: 2023-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel, Change From Baseline at Week 2 Reported
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
Prasugrel
Prasugrel 10 mg once daily first for 14 days, then Clopidogrel 75 mg once daily for 14 days
|
Clopidogrel
Clopidogrel 75 mg once daily first for 14 days, then Prasugrel 10 mg once daily for 14 days
|
|---|---|---|
|
First Intervention (14 Days)
STARTED
|
15
|
15
|
|
First Intervention (14 Days)
COMPLETED
|
15
|
15
|
|
First Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (14 Days)
STARTED
|
15
|
15
|
|
Second Intervention (14 Days)
COMPLETED
|
15
|
15
|
|
Second Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Platelet Inhibition in Patients With Systolic Heart Failure
Baseline characteristics by cohort
| Measure |
Prasugrel
n=15 Participants
Prasugrel 10 mg once daily for 2 weeks
Prasugrel 10 mg daily x 2 weeks
|
Clopidogrel
n=15 Participants
Clopidogrel 75 mg once daily for 2 weeks
Clopidogrel 75 mg daily x 2 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
58.5 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
58.5 years
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrel, Change From Baseline at Week 2 ReportedOutcome measures
| Measure |
Prasugrel
n=30 Participants
Prasugrel 10 mg once daily for 2 weeks
Prasugrel 10 mg daily x 2 weeks
|
Clopidogrel
n=30 Participants
Clopidogrel 75 mg once daily for 2 weeks
Clopidogrel 75 mg daily x 2 weeks
|
|---|---|---|
|
The Change in Platelet Aggregation Measured by the Accumetrics (VerifyNow P2Y12) Assay Between Baseline and Each Antiplatelet Medication
|
66.4 PRU (P2Y12 reactivity units)
Standard Deviation 51.5
|
156.2 PRU (P2Y12 reactivity units)
Standard Deviation 51.5
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrelOutcome measures
| Measure |
Prasugrel
n=26 Participants
Prasugrel 10 mg once daily for 2 weeks
Prasugrel 10 mg daily x 2 weeks
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg once daily for 2 weeks
Clopidogrel 75 mg daily x 2 weeks
|
|---|---|---|
|
The Change in Light Transmission Aggregometry (LTA)Between Baseline and Each Antiplatelet Medication
5 umol/L ADP
|
32 percentage of platelt inhibition
Standard Deviation 18
|
47 percentage of platelt inhibition
Standard Deviation 19
|
|
The Change in Light Transmission Aggregometry (LTA)Between Baseline and Each Antiplatelet Medication
20 umol/L ADP
|
38 percentage of platelt inhibition
Standard Deviation 19
|
54 percentage of platelt inhibition
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks post clopidogrel, and 2 weeks post prasugrelOutcome measures
| Measure |
Prasugrel
n=26 Participants
Prasugrel 10 mg once daily for 2 weeks
Prasugrel 10 mg daily x 2 weeks
|
Clopidogrel
n=26 Participants
Clopidogrel 75 mg once daily for 2 weeks
Clopidogrel 75 mg daily x 2 weeks
|
|---|---|---|
|
The Change in Platelet Activation Assay (VASP)Between Baseline and Each Antiplatelet Medication
|
25 PRI (platelt reactivity index)
Standard Deviation 20
|
49 PRI (platelt reactivity index)
Standard Deviation 16
|
Adverse Events
Prasugrel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Clopidogrel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prasugrel
n=30 participants at risk
Prasugrel 10 mg once daily for 2 weeks
Prasugrel 10 mg daily x 2 weeks
|
Clopidogrel
n=30 participants at risk
Clopidogrel 75 mg once daily for 2 weeks
Clopidogrel 75 mg daily x 2 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Brusing
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place