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Trial Outcomes & Findings for Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes (NCT NCT01852214)

NCT ID: NCT01852214

Last Updated: 2016-10-17

Results Overview

The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

1 week

Results posted on

2016-10-17

Participant Flow

Between February 2013 and July 2015, a total of 61 subjects agreed to participate in the study; 11 subjects were excluded and thus a total of 50 subjects were randomized (prasugrel first n=26; ticagrelor first n=24).

11 subjects were excluded before randomization: withdrawn of consent (n=4), screen failure (n=4), unable to draw blood (n=3).

Participant milestones

Participant milestones
Measure
Prasugrel First, Then Ticagrelor
Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose
Ticagrelor First, Then Prasugrel
Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose
Period 1
STARTED
26
24
Period 1
COMPLETED
25
21
Period 1
NOT COMPLETED
1
3
Washout Period
STARTED
25
21
Washout Period
COMPLETED
25
20
Washout Period
NOT COMPLETED
0
1
Period 2
STARTED
25
20
Period 2
COMPLETED
25
20
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Prasugrel First, Then Ticagrelor
Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose
Ticagrelor First, Then Prasugrel
Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose
Period 1
Adverse Event
1
2
Period 1
Withdrawal by Subject
0
1
Washout Period
Withdrawal by Subject
0
1

Baseline Characteristics

Pharmacodynamic Effect of Prasugrel vs. Ticagrelor in Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Population
n=46 Participants
Subjects with type 2 diabetes mellitus and coronary artery disease
Age, Continuous
59 years
STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
Sex: Female, Male
Male
33 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
16 Participants
n=5 Participants
Race (NIH/OMB)
White
30 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Type of diabetes
Insulin-dependent
26 participants
n=5 Participants
Type of diabetes
Non-insulin-dependent
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: All analyses of platelet function conducted on all randomized subjects who received study drug, successfully completed at least one treatment period of the study and had valid data for the primary end point.

The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence.

Outcome measures

Outcome measures
Measure
Prasugrel
n=45 Participants
Patients received 60mg loading dose and 10mg maintenance dose
Ticagrelor
n=46 Participants
Patients received a 180mg loading dose and 90mg bid maintenance dose
P2Y12 Reaction Units
83 PRU
Interval 63.0 to 103.0
52 PRU
Interval 32.0 to 72.0

SECONDARY outcome

Timeframe: 2 hours

Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel)

Outcome measures

Outcome measures
Measure
Prasugrel
n=45 Participants
Patients received 60mg loading dose and 10mg maintenance dose
Ticagrelor
n=46 Participants
Patients received a 180mg loading dose and 90mg bid maintenance dose
P2Y12 Reaction Units
97 PRU
Interval 78.0 to 117.0
75 PRU
Interval 56.0 to 95.0

SECONDARY outcome

Timeframe: 1 week

The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.

Outcome measures

Outcome measures
Measure
Prasugrel
n=45 Participants
Patients received 60mg loading dose and 10mg maintenance dose
Ticagrelor
n=46 Participants
Patients received a 180mg loading dose and 90mg bid maintenance dose
Platelet Reactivity Index
36 PRI
Interval 30.0 to 41.0
36 PRI
Interval 30.0 to 42.0

SECONDARY outcome

Timeframe: 2 hours

The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.

Outcome measures

Outcome measures
Measure
Prasugrel
n=45 Participants
Patients received 60mg loading dose and 10mg maintenance dose
Ticagrelor
n=46 Participants
Patients received a 180mg loading dose and 90mg bid maintenance dose
Platelet Reactivity Index
35 PRI
Interval 25.0 to 45.0
37 PRI
Interval 29.0 to 46.0

Adverse Events

Safety Population: Patients Receiving Prasugrel

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Safety Population: Patients Receiving Ticagrelor

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Safety Population: Patients Receiving Prasugrel
n=46 participants at risk
Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
Safety Population: Patients Receiving Ticagrelor
n=49 participants at risk
Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
Blood and lymphatic system disorders
BARC type 1 bleeding
2.2%
1/46 • Through study completion, up to 46 days.
2.0%
1/49 • Through study completion, up to 46 days.
Respiratory, thoracic and mediastinal disorders
Dyspnea
6.5%
3/46 • Through study completion, up to 46 days.
18.4%
9/49 • Through study completion, up to 46 days.

Additional Information

Dominick J. Angiolillo, MD, PhD

University of Florida College of Medicine-Jacksonville

Phone: +1-904-244-3933

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place