Trial Outcomes & Findings for Prasugrel Re-load Strategies (NCT NCT01201772)

NCT ID: NCT01201772

Last Updated: 2013-01-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

4 hours after treatment

Results posted on

2013-01-18

Participant Flow

Patients recuited at outpatient cardiology clinics

Seventy-seven patients on maintenance prasugrel therapy were screened. Of these, 11 patients refused to participate in the study and one patient was excluded due to a positive pregnancy test. Thus, a total of 65 patients were randomized.

Participant milestones

Participant milestones
Measure	Prasugrel 10mg Prasugrel was administered as one 10 mg tablet	Prasugrel 30mg Prasugrel was administered as three 10 mg tablet	Prasugrel 60mg Prasugrel was administered as six 10 mg tablet
Overall Study STARTED	23	21	21
Overall Study COMPLETED	22	21	21
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prasugrel Re-load Strategies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prasugrel 10mg n=23 Participants Prasugrel was administered as one 10 mg tablet	Prasugrel 30mg n=21 Participants Prasugrel was administered as three 10 mg tablets	Prasugrel 60mg n=21 Participants Prasugrel was administered as six 10 mg tablets	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=99 Participants	21 Participants n=107 Participants	21 Participants n=206 Participants	65 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age Continuous	56 years STANDARD_DEVIATION 7 • n=99 Participants	54 years STANDARD_DEVIATION 7 • n=107 Participants	52 years STANDARD_DEVIATION 9 • n=206 Participants	54 years STANDARD_DEVIATION 7 • n=7 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	8 Participants n=107 Participants	3 Participants n=206 Participants	18 Participants n=7 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	13 Participants n=107 Participants	18 Participants n=206 Participants	47 Participants n=7 Participants
Region of Enrollment United States	23 participants n=99 Participants	21 participants n=107 Participants	21 participants n=206 Participants	65 participants n=7 Participants

PRIMARY outcome

Timeframe: 4 hours after treatment

Population: A total of 65 patients were randomized. One patient assigned to the 10mg prasugrel group was withdrawn after randomization due to anemia identified after baseline blood sampling. Finally, 64 patients \[10 mg (n=22), 30 mg (n=21) and 60 mg (n=21)\] completed all time periods of the study.

Outcome measures

Outcome measures
Measure	Prasugrel 10mg n=22 Participants Prasugrel was administered as one 10 mg tablet	Prasugrel 30mg n=21 Participants Prasugrel was administered as three 10 mg tablets	Prasugrel 60mg n=21 Participants Prasugrel was administered as six 10 mg tablets
PRI Levels at 4 Hours	28.8 percentage of platelet reactivity Standard Error 2.8	11 percentage of platelet reactivity Standard Error 2.9	2.8 percentage of platelet reactivity Standard Error 2.7

Adverse Events

All Study Participants

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

Dominick Angiolillo

University of Florida

Phone: 904-244-3933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place