Trial Outcomes & Findings for Antithrombotic Effects of Ticagrelor Versus Clopidogrel (NCT NCT01642238)
NCT ID: NCT01642238
Last Updated: 2016-07-11
Results Overview
Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Pre-treatment baseline and 1 hour
Results posted on
2016-07-11
Participant Flow
15 healthy volunteers recruited between July 2012 and March 2013
Participant milestones
| Measure |
Ticagrelor, Then Clopidogrel
Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
|
Clopidogrel, Then Ticagrelor
Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
7
|
8
|
|
First Intervention (1 Day)
COMPLETED
|
7
|
8
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (1-2 Weeks)
STARTED
|
7
|
8
|
|
Washout (1-2 Weeks)
COMPLETED
|
7
|
8
|
|
Washout (1-2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
7
|
8
|
|
Second Intervention (1 Day)
COMPLETED
|
7
|
8
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antithrombotic Effects of Ticagrelor Versus Clopidogrel
Baseline characteristics by cohort
| Measure |
Antithrombotic Effects
n=15 Participants
Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.
|
|---|---|
|
Age, Continuous
|
31.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Body mass index
|
27.0 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment baseline and 1 hourChange in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Platelet-thrombus Formation in an ex Vivo Model of Thrombosis
|
56.3 percent change
Interval 43.5 to 69.0
|
35.2 percent change
Interval 23.9 to 46.5
|
PRIMARY outcome
Timeframe: Pre-treatment baseline and 24 hrs post treatmentChange in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Platelet-thrombus Formation in an ex Vivo Model of Thrombosis
|
34.1 percent change
Interval 24.3 to 43.9
|
18.5 percent change
Interval 4.2 to 32.7
|
SECONDARY outcome
Timeframe: Pre-treatment baselinePlatelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Platelet Reactivity
|
2.9 percent inhibition
Interval 0.5 to 5.3
|
3.7 percent inhibition
Interval 0.9 to 6.6
|
SECONDARY outcome
Timeframe: 1 hr post-treatmentPlatelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Platelet Reactivity
|
69.4 percent inhibition
Interval 52.9 to 85.9
|
20.1 percent inhibition
Interval 14.5 to 25.8
|
SECONDARY outcome
Timeframe: 24-hours post-treatmentPlatelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Platelet Reactivity
|
67.4 percent inhibition
Interval 54.7 to 80.1
|
53.4 percent inhibition
Interval 38.7 to 68.1
|
SECONDARY outcome
Timeframe: Pre-treatment baselineCoagulation times, assessed using the ROTEM thromboelastometry
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Blood Thrombogenicity
|
53.1 seconds
Interval 48.8 to 57.5
|
51.1 seconds
Interval 45.0 to 57.2
|
SECONDARY outcome
Timeframe: 1 hr post-treatmentCoagulation times, assessed using the ROTEM thromboelastometry
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Blood Thrombogenicity
|
163.1 seconds
Interval 145.8 to 180.5
|
174.0 seconds
Interval 155.5 to 192.5
|
SECONDARY outcome
Timeframe: 24-hours post-treatmentCoagulation times, assessed using the ROTEM thromboelastometry
Outcome measures
| Measure |
Ticagrelor + ASA + Bivalirudin
n=15 Participants
Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
Clopidogrel + ASA + Bivalirudin
n=15 Participants
Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
|
|---|---|---|
|
Blood Thrombogenicity
|
56.1 seconds
Interval 50.8 to 61.4
|
54.3 seconds
Interval 49.6 to 59.1
|
Adverse Events
Ticagrelor, Then Clopidogrel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidogrel, Then Ticagrelor
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
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-8484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place