Trial Outcomes & Findings for Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size (NCT NCT03043274)

Last Updated: 2020-06-30

Results Overview

Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

48 hours and 3 months

Results posted on

2020-06-30

Participant Flow

Patients were recruited in the cardiac catheterization laboratory.

Patients were randomized upon recruitment to the standard of care alone or standard of care in addition to cangrelor

Participant milestones

Participant milestones
Measure	Cangrelor Patients received standard of care in addition to cangrelor with a dose of 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion, started prior to PPCI, and continued for 2 hours or for the duration of the procedure, whichever is longer.	No Cangrelor This arm received standard of care alone
Overall Study STARTED	13	10
Overall Study COMPLETED	13	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cangrelor n=13 Participants The final subject count in this arm is 13.	No Cangrelor n=9 Participants The final subject number in this arm is 9.	Total n=22 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 10.7 • n=5 Participants	57.4 years STANDARD_DEVIATION 7.7 • n=7 Participants	58.2 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
BMI	28.8 kg/m2 STANDARD_DEVIATION 2 • n=5 Participants	31.6 kg/m2 STANDARD_DEVIATION 8.1 • n=7 Participants	29.96 kg/m2 STANDARD_DEVIATION 7.24 • n=5 Participants
Diabetes	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Hypertension	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Hyperlipidemia	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Peripehral vascular disease	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
No prior platelet therapy	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours and 3 months

Population: standard of care alone vs. Standard of care in addition to cangrelor

Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group.

Outcome measures

Outcome measures
Measure	Cangrelor n=13 Participants The final subject count in this arm is 13.	No Cangrelor n=9 Participants The final subject number in this arm is 9.
Change in Myocardial Infarction Size 3 months	6.7 percent of left ventricular mass Standard Error 1.5	6.98 percent of left ventricular mass Standard Error 2.1
Change in Myocardial Infarction Size 48 hours	8.6 percent of left ventricular mass Standard Error 1.6	11.1 percent of left ventricular mass Standard Error 2.1

SECONDARY outcome

Timeframe: 10 minutes

Population: standard of care alone vs. Standard of care in addition to cangrelor

Platelet reactivity testing will be performed 10 minutes after infusion has started.

Outcome measures

Outcome measures
Measure	Cangrelor n=13 Participants The final subject count in this arm is 13.	No Cangrelor n=9 Participants The final subject number in this arm is 9.
Platelet Reactivity ADP-induced aggregation	102.2 seconds Standard Error 24.88	333.4 seconds Standard Error 63.3
Platelet Reactivity TRAP-induced aggregation	285.8 seconds Standard Error 86.1	624.8 seconds Standard Error 106

SECONDARY outcome

Timeframe: 6 hours

Population: standard of care alone vs. Standard of care in addition to cangrelor

Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.

Outcome measures

Outcome measures
Measure	Cangrelor n=13 Participants The final subject count in this arm is 13.	No Cangrelor n=9 Participants The final subject number in this arm is 9.
Peripheral Blood Count Quantification granulocyte platelet aggregates	1166.7 cells per microliter Standard Error 190.7	2550.4 cells per microliter Standard Error 533.7
Peripheral Blood Count Quantification Monocyte-platelet aggregate	139.8 cells per microliter Standard Error 31.1	333.9 cells per microliter Standard Error 44.9

SECONDARY outcome

Timeframe: 6 hours

Population: Plasma level

ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.

Outcome measures

Outcome measures
Measure	Cangrelor n=13 Participants The final subject count in this arm is 13.	No Cangrelor n=9 Participants The final subject number in this arm is 9.
Interferon (IFN)-α2	33.2 pg/mL Standard Error 5.9	57.8 pg/mL Standard Error 4.6

SECONDARY outcome

Timeframe: 6 hours

Population: Plasma levels

ELISA assay.

Outcome measures

Outcome measures
Measure	Cangrelor n=13 Participants The final subject count in this arm is 13.	No Cangrelor n=9 Participants The final subject number in this arm is 9.
IFN-γ	41.4 pg/mL Standard Error 8.5	103.3 pg/mL Standard Error 19.6

SECONDARY outcome

Timeframe: 6 hours

Population: plasma levels

ELISA assay macrophage-derived chemokine

Outcome measures

Outcome measures
Measure	Cangrelor n=13 Participants The final subject count in this arm is 13.	No Cangrelor n=9 Participants The final subject number in this arm is 9.
Macrophage-derived Chemokine	593.3 pg/mL Standard Error 44	873.8 pg/mL Standard Error 63.8

Adverse Events

Cangrelor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Cangrelor

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. Khaled M. Ziada

University of Kentucky

Phone: 8593236036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place