Trial Outcomes & Findings for Reversing Ticagrelor's Effects With Fresh Platelets (NCT NCT02201394)
NCT ID: NCT02201394
Last Updated: 2017-12-05
Results Overview
Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose
Results posted on
2017-12-05
Participant Flow
Participant milestones
| Measure |
Patients With Stable CVD
DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
|
|---|---|
|
Loading Dose
STARTED
|
20
|
|
Loading Dose
COMPLETED
|
20
|
|
Loading Dose
NOT COMPLETED
|
0
|
|
Maintenance Dose
STARTED
|
20
|
|
Maintenance Dose
COMPLETED
|
20
|
|
Maintenance Dose
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reversing Ticagrelor's Effects With Fresh Platelets
Baseline characteristics by cohort
| Measure |
Patients With Stable CVD
n=20 Participants
DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
|
|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Diabetic
|
15 Participants
n=99 Participants
|
|
BMI
|
30.7 kg/m^2
STANDARD_DEVIATION 4.5 • n=99 Participants
|
|
Hypertension
|
16 Participants
n=99 Participants
|
|
Systolic blood pressure
|
127.2 mm Hg
STANDARD_DEVIATION 17.5 • n=99 Participants
|
|
Diastolic blood pressure
|
70.6 mm Hg
STANDARD_DEVIATION 9.0 • n=99 Participants
|
|
Hypercholesterolemia
|
19 Participants
n=99 Participants
|
|
Cholesterol level
|
158.7 mg/dL
STANDARD_DEVIATION 62.0 • n=99 Participants
|
|
Triglycerides level
|
165.4 mg/dL
STANDARD_DEVIATION 91.4 • n=99 Participants
|
|
LDL level
|
85.6 mg/dL
STANDARD_DEVIATION 51.7 • n=99 Participants
|
|
HDL
|
42.5 mg/dL
STANDARD_DEVIATION 12.6 • n=99 Participants
|
|
Smoking History
Current
|
2 Participants
n=99 Participants
|
|
Smoking History
Past
|
8 Participants
n=99 Participants
|
|
Smoking History
Never
|
10 Participants
n=99 Participants
|
|
Alcohol Use
Current
|
9 Participants
n=99 Participants
|
|
Alcohol Use
Past
|
3 Participants
n=99 Participants
|
|
Alcohol Use
Never
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dosePopulation: Patients with stable CVD
Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.
Outcome measures
| Measure |
Maintenance Dose
n=20 Participants
Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week
|
Loading Dose
n=20 Participants
Ticagrelor (180 mg) + ASA (325 mg).
|
|---|---|---|
|
P2Y12 Reaction Unit (PRU)
Baseline
|
284.1 PRU
Standard Deviation 42.2
|
284.1 PRU
Standard Deviation 42.2
|
|
P2Y12 Reaction Unit (PRU)
Post-dose 4 hours 0%
|
37.5 PRU
Standard Deviation 32.4
|
39.1 PRU
Standard Deviation 25.9
|
|
P2Y12 Reaction Unit (PRU)
4 hours 25%
|
72.2 PRU
Standard Deviation 38.5
|
69.6 PRU
Standard Deviation 35.6
|
|
P2Y12 Reaction Unit (PRU)
4 hours 50%
|
88.4 PRU
Standard Deviation 42.9
|
100.3 PRU
Standard Deviation 49.6
|
|
P2Y12 Reaction Unit (PRU)
4 hours 75%
|
85.9 PRU
Standard Deviation 49.4
|
98.6 PRU
Standard Deviation 54.4
|
|
P2Y12 Reaction Unit (PRU)
Post-dose 6 hours 0%
|
24.0 PRU
Standard Deviation 30.3
|
25.9 PRU
Standard Deviation 28.9
|
|
P2Y12 Reaction Unit (PRU)
6 hours 25%
|
46.0 PRU
Standard Deviation 37.3
|
55.3 PRU
Standard Deviation 50.2
|
|
P2Y12 Reaction Unit (PRU)
6 hours 50%
|
55.4 PRU
Standard Deviation 41.8
|
67.8 PRU
Standard Deviation 53.8
|
|
P2Y12 Reaction Unit (PRU)
6 hours 75%
|
67.7 PRU
Standard Deviation 45.3
|
71.2 PRU
Standard Deviation 42.8
|
|
P2Y12 Reaction Unit (PRU)
Post-dose 24 hours 0%
|
119.0 PRU
Standard Deviation 78.0
|
127.6 PRU
Standard Deviation 58.8
|
|
P2Y12 Reaction Unit (PRU)
24 hours 25%
|
147.6 PRU
Standard Deviation 65.2
|
157.3 PRU
Standard Deviation 52.5
|
|
P2Y12 Reaction Unit (PRU)
24 hours 50%
|
158.0 PRU
Standard Deviation 43.5
|
165.9 PRU
Standard Deviation 40.5
|
|
P2Y12 Reaction Unit (PRU)
24 hours 75%
|
154.0 PRU
Standard Deviation 51.0
|
162.5 PRU
Standard Deviation 29.4
|
|
P2Y12 Reaction Unit (PRU)
Post-dose 48 hours 0%
|
214.8 PRU
Standard Deviation 74.0
|
250.6 PRU
Standard Deviation 45.8
|
|
P2Y12 Reaction Unit (PRU)
48 hours 25%
|
219.7 PRU
Standard Deviation 52.2
|
249.5 PRU
Standard Deviation 35.1
|
|
P2Y12 Reaction Unit (PRU)
48 hours 50%
|
221.2 PRU
Standard Deviation 44.2
|
226.2 PRU
Standard Deviation 51.6
|
|
P2Y12 Reaction Unit (PRU)
48 hours 75%
|
203.9 PRU
Standard Deviation 41.5
|
204.2 PRU
Standard Deviation 45.9
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dosePopulation: Patients with stable CVD
Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU \* min.
Outcome measures
| Measure |
Maintenance Dose
n=20 Participants
Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week
|
Loading Dose
n=20 Participants
Ticagrelor (180 mg) + ASA (325 mg).
|
|---|---|---|
|
Platelet Aggregation Using Multiplate Analyzer
Baseline (pre-dose
|
67.0 10 AU * min
Standard Deviation 14.3
|
67.0 10 AU * min
Standard Deviation 14.3
|
|
Platelet Aggregation Using Multiplate Analyzer
Post-dose 4 hours 0%
|
15.7 10 AU * min
Standard Deviation 6.7
|
13.6 10 AU * min
Standard Deviation 4.6
|
|
Platelet Aggregation Using Multiplate Analyzer
4 hours 25%
|
20.9 10 AU * min
Standard Deviation 6.1
|
18.7 10 AU * min
Standard Deviation 5.2
|
|
Platelet Aggregation Using Multiplate Analyzer
4 hours 50%
|
22.1 10 AU * min
Standard Deviation 5.9
|
21.4 10 AU * min
Standard Deviation 7.7
|
|
Platelet Aggregation Using Multiplate Analyzer
4 hours 75%
|
24.2 10 AU * min
Standard Deviation 6.3
|
23.6 10 AU * min
Standard Deviation 8.4
|
|
Platelet Aggregation Using Multiplate Analyzer
Post-dose 6 hours 0%
|
13.4 10 AU * min
Standard Deviation 6.0
|
12.3 10 AU * min
Standard Deviation 5.9
|
|
Platelet Aggregation Using Multiplate Analyzer
6 hours 25%
|
16.5 10 AU * min
Standard Deviation 5.5
|
17.3 10 AU * min
Standard Deviation 6.1
|
|
Platelet Aggregation Using Multiplate Analyzer
6 hours 50%
|
18.9 10 AU * min
Standard Deviation 6.3
|
20.7 10 AU * min
Standard Deviation 6.5
|
|
Platelet Aggregation Using Multiplate Analyzer
6 hours 75%
|
20.4 10 AU * min
Standard Deviation 6.2
|
22.3 10 AU * min
Standard Deviation 7.5
|
|
Platelet Aggregation Using Multiplate Analyzer
Post dose 24 hours 0%
|
25.6 10 AU * min
Standard Deviation 15.6
|
24.9 10 AU * min
Standard Deviation 14.0
|
|
Platelet Aggregation Using Multiplate Analyzer
24 hours 25%
|
35.5 10 AU * min
Standard Deviation 15.1
|
39.7 10 AU * min
Standard Deviation 18.1
|
|
Platelet Aggregation Using Multiplate Analyzer
24 hours 50%
|
43.3 10 AU * min
Standard Deviation 16.7
|
49.3 10 AU * min
Standard Deviation 17.9
|
|
Platelet Aggregation Using Multiplate Analyzer
24 hours 75%
|
47.5 10 AU * min
Standard Deviation 18.2
|
52.8 10 AU * min
Standard Deviation 22.7
|
|
Platelet Aggregation Using Multiplate Analyzer
Post-dose 48 hours 0%
|
39.1 10 AU * min
Standard Deviation 21.3
|
41.3 10 AU * min
Standard Deviation 17.7
|
|
Platelet Aggregation Using Multiplate Analyzer
48 hours 25%
|
56.8 10 AU * min
Standard Deviation 19.5
|
57.7 10 AU * min
Standard Deviation 17.6
|
|
Platelet Aggregation Using Multiplate Analyzer
48 hours 50%
|
63.8 10 AU * min
Standard Deviation 19.1
|
68.6 10 AU * min
Standard Deviation 20.4
|
|
Platelet Aggregation Using Multiplate Analyzer
48 hours 75%
|
70.3 10 AU * min
Standard Deviation 23.0
|
72.8 10 AU * min
Standard Deviation 18.4
|
Adverse Events
Patients With Stable CVD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Juan J. Badimon
Atherothrombosis Research Unit, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place