Trial Outcomes & Findings for Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease (NCT NCT01852175)

Results Overview

The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

1 week

Results posted on

2015-06-10

Participant Flow

Between December 2011 to June 2014 patients were screened at the outpatient cardiology clinics, UF Health, University of Florida, Jacksonville.

Participant milestones

Participant milestones
Measure	Prasugrel Prasugrel 60mg loading dose and 10 mg maintenance dose	Ticagrelor Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Overall Study STARTED	55	55
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prasugrel n=55 Participants Prasugrel 60mg loading dose and 10 mg maintenance dose	Ticagrelor n=55 Participants Ticagrelor 180mg loading dose and 90mg bid maintenance dose	Total n=110 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	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	55 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.

Outcome measures

Outcome measures
Measure	Prasugrel n=55 Participants Prasugrel 60mg loading dose and 10 mg maintenance dose	Ticagrelor n=55 Participants Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)	32.1 PRI% Standard Error 2.5	32.6 PRI% Standard Error 2.7

SECONDARY outcome

Timeframe: 2 hours

A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.

Outcome measures

Outcome measures
Measure	Prasugrel n=55 Participants Prasugrel 60mg loading dose and 10 mg maintenance dose	Ticagrelor n=55 Participants Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)	13.4 PRI% Standard Error 2.7	15.6 PRI% Standard Error 3

SECONDARY outcome

Timeframe: 24 hours

A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.

Outcome measures

Outcome measures
Measure	Prasugrel n=55 Participants Prasugrel 60mg loading dose and 10 mg maintenance dose	Ticagrelor n=55 Participants Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)	14.2 PRI% Standard Error 2.2	26.4 PRI% Standard Error 2.2

Adverse Events

Prasugrel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ticagrelor

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prasugrel n=55 participants at risk Prasugrel 60mg loading dose and 10 mg maintenance dose	Ticagrelor n=55 participants at risk Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/55 • 1 week Adverse events, including bleeding, bradyarrhythmias, and dyspnea, defined according to previously reported criteria were recorded	9.1% 5/55 • Number of events 5 • 1 week Adverse events, including bleeding, bradyarrhythmias, and dyspnea, defined according to previously reported criteria were recorded

Additional Information

Dominick J. Angiolillo, MD, PhD-Associate Professor of Medicine Director, Cardiovascular Research

University of Florida College of Medicine-Jacksonville

Phone: +1-904-244-3005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place