Trial Outcomes & Findings for Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI (NCT NCT04668144)
NCT ID: NCT04668144
Last Updated: 2024-03-20
Results Overview
The primary end point of the study will be the non-inferiority in P2Y12 reaction units (PRU) of cangrelor plus prasugrel concomitantly administered at the start of PCI versus prasugrel only administered at the start of PCI.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
359 participants
Primary outcome timeframe
4 hours
Results posted on
2024-03-20
Participant Flow
Between February 18, 2021 and February 2, 2023, 359 patients provided written informed consent to participate in the study
282 patients were excluded because they had at least one exclusion criteria.
Participant milestones
| Measure |
Prasugrel
Prasugrel only administered at the start of PCI
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Prasugrel + Cangrelor
Cangrelor plus prasugrel concomitantly administered at the start of PCI
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Cangrelor Followed by Prasugrel
Cangrelor administered at the start of PCI plus prasugrel administered at the end of the cangrelor infusion
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
27
|
|
Overall Study
COMPLETED
|
25
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Prasugrel
Prasugrel only administered at the start of PCI
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Prasugrel + Cangrelor
Cangrelor plus prasugrel concomitantly administered at the start of PCI
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Cangrelor Followed by Prasugrel
Cangrelor administered at the start of PCI plus prasugrel administered at the end of the cangrelor infusion
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
Baseline Characteristics
Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI
Baseline characteristics by cohort
| Measure |
Prasugrel
n=25 Participants
Prasugrel only administered at the start of PCI
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Prasugrel + Cangrelor
n=25 Participants
Cangrelor plus prasugrel concomitantly administered at the start of PCI
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Cangrelor Followed by Prasugrel
n=27 Participants
Cangrelor administered at the start of PCI plus prasugrel administered at the end of the cangrelor infusion
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 9 • n=5 Participants
|
64 years
STANDARD_DEVIATION 8 • n=7 Participants
|
63 years
STANDARD_DEVIATION 8 • n=5 Participants
|
63 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Acute coronary syndrome
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Patient with valid primary end point data
The primary end point of the study will be the non-inferiority in P2Y12 reaction units (PRU) of cangrelor plus prasugrel concomitantly administered at the start of PCI versus prasugrel only administered at the start of PCI.
Outcome measures
| Measure |
Prasugrel
n=24 Participants
Prasugrel only administered at the start of PCI
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Prasugrel + Cangrelor
n=24 Participants
Cangrelor plus prasugrel concomitantly administered at the start of PCI
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Cangrelor Followed by Prasugrel
n=24 Participants
Cangrelor administered at the start of PCI plus prasugrel administered at the end of the cangrelor infusion
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
|---|---|---|---|
|
Platelet Reactivity Measured by VerifyNow
|
23 PRU
Standard Deviation 31
|
153 PRU
Standard Deviation 104
|
65 PRU
Standard Deviation 84
|
Adverse Events
Prasugrel
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Prasugrel + Cangrelor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cangrelor Followed by Prasugrel
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel
n=25 participants at risk
Prasugrel only administered at the start of PCI
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Prasugrel + Cangrelor
n=25 participants at risk
Cangrelor plus prasugrel concomitantly administered at the start of PCI
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Cangrelor Followed by Prasugrel
n=27 participants at risk
Cangrelor administered at the start of PCI plus prasugrel administered at the end of the cangrelor infusion
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
|---|---|---|---|
|
Cardiac disorders
Asystole
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
3.7%
1/27 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/25 • 7 days
|
0.00%
0/25 • 7 days
|
3.7%
1/27 • Number of events 1 • 7 days
|
Other adverse events
| Measure |
Prasugrel
n=25 participants at risk
Prasugrel only administered at the start of PCI
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Prasugrel + Cangrelor
n=25 participants at risk
Cangrelor plus prasugrel concomitantly administered at the start of PCI
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
Cangrelor Followed by Prasugrel
n=27 participants at risk
Cangrelor administered at the start of PCI plus prasugrel administered at the end of the cangrelor infusion
Cangrelor: Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Minor bleeding
|
32.0%
8/25 • Number of events 8 • 7 days
|
8.0%
2/25 • Number of events 2 • 7 days
|
14.8%
4/27 • Number of events 4 • 7 days
|
Additional Information
Francesco Franchi, MD
University of Florida College of Medicine Jacksonville
Phone: 904244206
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place