Trial Outcomes & Findings for Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI (NCT NCT01962428)
NCT ID: NCT01962428
Last Updated: 2016-11-09
Results Overview
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
250 participants
Primary outcome timeframe
2 hours after the loading dose of ticagrelor
Results posted on
2016-11-09
Participant Flow
A total of 278 patients were recruited at 8 centers in Beijing and allocated into two groups using block randomization: a high LD group (360 mg) and a conventional LD group (180 mg).
Patients excluded(n=564)
Participant milestones
| Measure |
High Loading Dose of Ticagrelor
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
Conventional Loading Dose of Ticagrelor
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
139
|
|
Overall Study
COMPLETED
|
129
|
133
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
Baseline characteristics by cohort
| Measure |
High Loading Dose of Ticagrelor
n=129 Participants
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
Conventional Loading Dose of Ticagrelor
n=133 Participants
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 9.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
129 participants
n=5 Participants
|
133 participants
n=7 Participants
|
262 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours after the loading dose of ticagrelorVasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).
Outcome measures
| Measure |
Conventional Loading Dose of Ticagrelor
n=133 Participants
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
High Loading Dose of Ticagrelor
n=129 Participants
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
|---|---|---|
|
Platelet Reactivity Index(PRI) Measured by VASP-P
|
16.7 percentage of 100
Interval 4.3 to 21.3
|
12.2 percentage of 100
Interval 9.3 to 32.3
|
SECONDARY outcome
Timeframe: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelorOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: follow-up for 28 days after the loading dose of ticagrelorOutcome measures
Outcome data not reported
Adverse Events
Conventional Loading Dose of Ticagrelor
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
High Loading Dose of Ticagrelor
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional Loading Dose of Ticagrelor
n=139 participants at risk
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
High Loading Dose of Ticagrelor
n=139 participants at risk
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
|---|---|---|
|
Cardiac disorders
aortic dissection
|
0.72%
1/139 • Number of events 1 • 30 days
|
0.00%
0/129 • 30 days
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/139 • 30 days
|
0.72%
1/139 • Number of events 1 • 30 days
|
|
Cardiac disorders
death
|
0.72%
1/139 • Number of events 1 • 30 days
|
0.72%
1/139 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
AMI
|
0.72%
1/139 • Number of events 1 • 30 days
|
0.00%
0/139 • 30 days
|
|
Gastrointestinal disorders
gastrorrhagia
|
0.00%
0/139 • 30 days
|
0.72%
1/139 • Number of events 1 • 30 days
|
|
Cardiac disorders
failure of PCI
|
0.00%
0/139 • 30 days
|
1.4%
2/139 • Number of events 2 • 30 days
|
Other adverse events
| Measure |
Conventional Loading Dose of Ticagrelor
n=139 participants at risk
Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
High Loading Dose of Ticagrelor
n=139 participants at risk
Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.
ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
10.8%
15/139 • Number of events 15 • 30 days
|
13.7%
19/139 • Number of events 19 • 30 days
|
Additional Information
huiliang Liu
General Hospital of Chinese People's Armed Police Forces
Phone: +8601057976707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60