Trial Outcomes & Findings for Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction (NCT NCT02075125)

Results Overview

Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) \>235 and platelet reactivity index (PRI) \>50%.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

39 participants

Primary outcome timeframe

48 hours after loading dose of study drug

Results posted on

2017-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Prasugrel Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor Patient administer Ticagrelor 180 mg as loading dose followed by 90 mg twice a day as maintenance dose.
Overall Study STARTED	19	20
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prasugrel n=19 Participants Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.	Total n=39 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 10 • n=5 Participants	55 years STANDARD_DEVIATION 11 • n=7 Participants	55 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment Korea, Republic of	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants
Body Mass Index (BMI)	25.3 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants	24.4 kg/m^2 STANDARD_DEVIATION 2.4 • n=7 Participants	24.9 kg/m^2 STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: 48 hours after loading dose of study drug

Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.

Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) \>235 and platelet reactivity index (PRI) \>50%.

Outcome measures

Outcome measures
Measure	Prasugrel n=19 Participants Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Number of Participants With High Platelet Reactivity PRU>235	0 participants	0 participants
Number of Participants With High Platelet Reactivity VASP-PRI>50%	0 participants	0 participants

SECONDARY outcome

Timeframe: 30 days

Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.

Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.

Outcome measures

Outcome measures
Measure	Prasugrel n=19 Participants Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Major Adverse Cardiac and Cerebrovascular Events	0 participants	0 participants

SECONDARY outcome

Timeframe: 30 days

Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.

Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.

Outcome measures

Outcome measures
Measure	Prasugrel n=19 Participants Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Bleeding Event	0 participants	0 participants

SECONDARY outcome

Timeframe: 30 days

Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number, compared with chi-square statistics or Fisher's exact test, as appropriate.

Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.

Outcome measures

Outcome measures
Measure	Prasugrel n=19 Participants Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Adverse Drug Reaction	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline

Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).

Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).

Outcome measures

Outcome measures
Measure	Prasugrel n=19 Participants Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Pre-procedure P2Y12 Reaction Units (PRU)	259 PRU units Interval 230.0 to 281.0	261 PRU units Interval 196.0 to 286.0

SECONDARY outcome

Timeframe: 48 hours after loading dose of study drug

Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.

Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) \<85 and platelet reactivity index (PRI)\<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.

Outcome measures

Outcome measures
Measure	Prasugrel n=19 Participants Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Number of Participants With Low Platelet Reactivity PRU<85	18 participants	19 participants
Number of Participants With Low Platelet Reactivity VASP-PRI<16%	16 participants	16 participants

SECONDARY outcome

Timeframe: Baseline

Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).

Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).

Outcome measures

Outcome measures
Measure	Prasugrel n=19 Participants Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.	Ticagrelor n=20 Participants Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Pre-procedure Platelet Reactivity Index (PRI)	51.2 percentage Interval 39.3 to 61.3	47.5 percentage Interval 38.4 to 50.4

Adverse Events

Prasugrel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ticagrelor

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. Moo Hyun Kim; Director of Global Clinical Trial Center Dong-A University Hospital.

Department of Cardiology, College of Medicine, Dong-A University.

Phone: +82 (51) 240-2976

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place