Trial Outcomes & Findings for Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI (NCT NCT03247738)

NCT ID: NCT03247738

Last Updated: 2020-09-09

Results Overview

Platelet reactivity at 30 minutes after starting cangrelor or placebo assessed by VerifyNow PRU and reported as P2Y12 Reaction Units (PRU)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2020-09-09

Participant Flow

Between December 10, 2017 and July 17, 2018, there were a total of 99 STEMI patients with intent to undergo P-PCI that presented to our Institution, of whom 69 provided their written informed consent to participate in the study.

19 patients were not randomized because PCI was not performed or had newly identified exclusion criteria

Participant milestones

Measure	Cangrelor Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.	Placebo Normal saline bolus and infusion for 2 hours Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI

Baseline characteristics by cohort

Measure	Cangrelor n=25 Participants Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.	Placebo n=25 Participants Normal saline bolus and infusion for 2 hours Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.	Total n=50 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=5 Participants	60 years STANDARD_DEVIATION 10 • n=7 Participants	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 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	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	16 Participants n=7 Participants	36 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
Radial access	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Use of glycoprotein IIb/IIIa inhibitors	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: The analyzed patients included all patients with pharmacodynamic data and without a major protocol deviation thought to affect the pharmacodynamic effects of ticagrelor or cangrelor.

Platelet reactivity at 30 minutes after starting cangrelor or placebo assessed by VerifyNow PRU and reported as P2Y12 Reaction Units (PRU)

Outcome measures

Measure	Cangrelor n=22 Participants Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.	Placebo n=22 Participants Normal saline bolus and infusion for 2 hours Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
Platelet Reactivity Measured by VerifyNow PRU	63 P2Y12 reaction units (PRU) Interval 32.0 to 93.0	214 P2Y12 reaction units (PRU) Interval 183.0 to 245.0

SECONDARY outcome

Timeframe: 30 minutes

Platelet reactivity at 30 minutes after starting cangrelor or placebo measured by VASP and reported as platelet reactivity index (PRI%). Higher PRI% means higher platelet reactivity.

Outcome measures

Measure	Cangrelor n=22 Participants Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.	Placebo n=22 Participants Normal saline bolus and infusion for 2 hours Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)	29 platelet reactivity index (PRI) Interval 18.0 to 39.0	72 platelet reactivity index (PRI) Interval 61.0 to 82.0

Adverse Events

Cangrelor

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Cangrelor n=25 participants at risk Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.	Placebo n=25 participants at risk Normal saline bolus and infusion for 2 hours Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
Cardiac disorders Acute stent thrombosis	0.00% 0/25 • Until time of discharge The safety population was composed of all patients exposed to at least one dose of study medication (any time from randomization until completion of the study). Any adverse event until time of discharge was recorded.	4.0% 1/25 • Number of events 1 • Until time of discharge The safety population was composed of all patients exposed to at least one dose of study medication (any time from randomization until completion of the study). Any adverse event until time of discharge was recorded.

Other adverse events

Measure	Cangrelor n=25 participants at risk Cangrelor will be administered as 30 μg/kg bolus followed by 4 μg/kg/min infusion for 2 hours Cangrelor: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.	Placebo n=25 participants at risk Normal saline bolus and infusion for 2 hours Placebo: Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
Vascular disorders minor bleeding	12.0% 3/25 • Number of events 3 • Until time of discharge The safety population was composed of all patients exposed to at least one dose of study medication (any time from randomization until completion of the study). Any adverse event until time of discharge was recorded.	12.0% 3/25 • Number of events 3 • Until time of discharge The safety population was composed of all patients exposed to at least one dose of study medication (any time from randomization until completion of the study). Any adverse event until time of discharge was recorded.

Additional Information

Dominick J. Angiolillo

University of Florida College of Medicine, Jacksonville

Phone: 9042443933

Email: dominick.angiolillo@jax.ufl.edu

Results disclosure agreements

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