Trial Outcomes & Findings for Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients (NCT NCT01823510)
NCT ID: NCT01823510
Last Updated: 2017-12-08
Results Overview
Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
up to 7 days
Results posted on
2017-12-08
Participant Flow
Participant milestones
| Measure |
Tica-Clop
Participants received Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days).
|
Clop-Tica
Participants received Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days).
|
|---|---|---|
|
Days 1-7
STARTED
|
10
|
10
|
|
Days 1-7
COMPLETED
|
10
|
10
|
|
Days 1-7
NOT COMPLETED
|
0
|
0
|
|
Days 8-21
STARTED
|
10
|
10
|
|
Days 8-21
COMPLETED
|
10
|
10
|
|
Days 8-21
NOT COMPLETED
|
0
|
0
|
|
Days 22-28
STARTED
|
10
|
10
|
|
Days 22-28
COMPLETED
|
10
|
10
|
|
Days 22-28
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Type 2 Diabetic Patients
n=20 Participants
All participants receive both Ticagrelor and Clopidogrel (each with aspirin) in a cross-over design. Treatment sequence (Tica-Clop OR Clop-Tica) was randomly assigned and with a 2-week washout period in between (i.e., "Tica/Clop (5-7 days)", "Washout (14 days)", and "Clop/Tica (5-7 days)").
|
|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.9 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Diabetes, type-2
|
20 Participants
n=5 Participants
|
|
Hypertension
|
17 Participants
n=5 Participants
|
|
Hypercholesterolemia
|
19 Participants
n=5 Participants
|
|
Smoking
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 7 daysThrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).
Outcome measures
| Measure |
Ticagrelor + Aspirin
n=20 Participants
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
|
Clopidogrel + Aspirin
n=20 Participants
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
|
|---|---|---|
|
Thrombus Formation
2 hour post loading dose
|
66.9 percentage of baseline size
Standard Error 8.0
|
84.4 percentage of baseline size
Standard Error 6.4
|
|
Thrombus Formation
6 hours post loading dose
|
59.9 percentage of baseline size
Standard Error 8.0
|
79.8 percentage of baseline size
Standard Error 6.4
|
|
Thrombus Formation
5-7 days of maintenance dose
|
68.9 percentage of baseline size
Standard Error 8.3
|
82.6 percentage of baseline size
Standard Error 6.5
|
SECONDARY outcome
Timeframe: up to 7 daysPlatelet reactivity by Multiplate Analyzer
Outcome measures
| Measure |
Ticagrelor + Aspirin
n=20 Participants
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
|
Clopidogrel + Aspirin
n=20 Participants
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
|
|---|---|---|
|
Platelet Reactivity
2 hour post-loading dose
|
20.5 percentage of baseline Unit
Standard Error 7.4
|
54.5 percentage of baseline Unit
Standard Error 14.4
|
|
Platelet Reactivity
6 hour post-loading dose
|
20.6 percentage of baseline Unit
Standard Error 7.5
|
43.6 percentage of baseline Unit
Standard Error 14.6
|
|
Platelet Reactivity
5-7 days of maintenance dosing
|
24.2 percentage of baseline Unit
Standard Error 7.7
|
45.5 percentage of baseline Unit
Standard Error 14.4
|
SECONDARY outcome
Timeframe: up to 7 daysPlatelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow
Outcome measures
| Measure |
Ticagrelor + Aspirin
n=20 Participants
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
|
Clopidogrel + Aspirin
n=20 Participants
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
|
|---|---|---|
|
P2Y12 Reaction Unit (PRU)
2 hour post-loading dose
|
14.8 percentage of baseline PRU
Standard Error 7.2
|
77.8 percentage of baseline PRU
Standard Error 11.8
|
|
P2Y12 Reaction Unit (PRU)
6 hour post-loading dose
|
8.2 percentage of baseline PRU
Standard Error 7.5
|
66.8 percentage of baseline PRU
Standard Error 11.9
|
|
P2Y12 Reaction Unit (PRU)
5-7 days of maintenance dosing
|
14.5 percentage of baseline PRU
Standard Error 7.5
|
62.7 percentage of baseline PRU
Standard Error 11.8
|
SECONDARY outcome
Timeframe: up to 7 daysPlatelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay.
Outcome measures
| Measure |
Ticagrelor + Aspirin
n=20 Participants
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
|
Clopidogrel + Aspirin
n=20 Participants
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
|
|---|---|---|
|
Platelet Reactivity Index (PRI)
2 hour post-loading dose
|
21.8 percentage of baseline PRI
Standard Error 2.5
|
85.8 percentage of baseline PRI
Standard Error 3.3
|
|
Platelet Reactivity Index (PRI)
6 hour post-loading dose
|
17.8 percentage of baseline PRI
Standard Error 2.5
|
82.5 percentage of baseline PRI
Standard Error 3.4
|
|
Platelet Reactivity Index (PRI)
5-7 days of maintenance dosing
|
17.2 percentage of baseline PRI
Standard Error 2.5
|
68.4 percentage of baseline PRI
Standard Error 3.4
|
Adverse Events
Ticagrelor + Aspirin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clopidrogel + Aspirin
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 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