Trial Outcomes & Findings for Pharmacological Effects of Crushing Prasugrel in STEMI Patients (NCT NCT02212028)

NCT ID: NCT02212028

Last Updated: 2016-12-28

Results Overview

The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: 2 hrs
• Results posted on: 2016-12-28

Participant Flow

Between October 15, 2014, and August 12, 2015, there were a total of 123 patients presenting with a STEMI at the University of Florida Health-Jacksonville, that were screened.

45 patients did not meet study entry criteria, while 78 provided their written informed consent to participate in the study and, of these, 52 were randomized. the remaining subjects were not randomized because of exclusion criteria emerged after consenting.

Participant milestones

Measure	Prasugrel Crush Prasugrel 60mg loading dose as crushed tablets	Prasugrel Tablets Prasugrel 60 mg loading dose whole tablets
Overall Study STARTED	26	26
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacological Effects of Crushing Prasugrel in STEMI Patients

Baseline characteristics by cohort

Measure	Prasugrel Crush n=26 Participants Prasugrel 60mg loading dose as crushed tablets	Prasugrel Tablets n=24 Participants Prasugrel 60 mg loading dose whole tablets	Total n=50 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 9 • n=5 Participants	58 years STANDARD_DEVIATION 10 • n=7 Participants	58 years STANDARD_DEVIATION 10 • n=5 Participants
Gender Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Gender Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hrs

Population: The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.

The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration

Outcome measures

Measure	Prasugrel Crush n=26 Participants Prasugrel 60mg loading dose as crushed tablets	Prasugrel Tablets n=24 Participants Prasugrel 60 mg loading dose whole tablets
P2Y12 Reaction Units (PRU)	95 PRU Interval 55.0 to 135.0	164 PRU Interval 122.0 to 206.0

SECONDARY outcome

Timeframe: 2 hrs

Population: The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.

The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration

Outcome measures

Measure	Prasugrel Crush n=26 Participants Prasugrel 60mg loading dose as crushed tablets	Prasugrel Tablets n=24 Participants Prasugrel 60 mg loading dose whole tablets
Platelet Reactivity Index (PRI)	33 PRI Interval 20.0 to 46.0	61 PRI Interval 47.0 to 75.0

Adverse Events

Prasugrel Crush

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Prasugrel Tablets

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prasugrel Crush n=26 participants at risk Prasugrel 60mg loading dose as crushed tablets	Prasugrel Tablets n=26 participants at risk Prasugrel 60 mg loading dose whole tablets
Renal and urinary disorders Minor bleeding	3.8% 1/26 • Number of events 1 • 3 days In-hospital adverse events, including ischemic and bleeding complications were recorded.	0.00% 0/26 • 3 days In-hospital adverse events, including ischemic and bleeding complications were recorded.

Additional Information

Dominick J. Angiolillo, MD, PhD

University of Florida College of Medicine-Jacksonville

Phone: +1-904-244-3933

Email: dominick.angiolillo@jax.ufl.edu

Results disclosure agreements

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