Trial Outcomes & Findings for Short-Term Application of Tocilizumab Following Myocardial Infarction (NCT NCT02419937)

NCT ID: NCT02419937

Last Updated: 2017-11-17

Results Overview

30 day rate of major adverse cardiac events (MACE) following administration of Tocilizumab subcutaneously single dose within 24 hours of NSTEMI or STEMI as compared to administration of placebo

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: 30 days after one time injection
• Results posted on: 2017-11-17

Participant Flow

Participant milestones

Measure	Tocilizumab Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once. Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)	Placebo Blinded subjects will be randomized to placebo Placebo: Saline injection
Overall Study STARTED	12	16
Overall Study COMPLETED	11	16
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Tocilizumab Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once. Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)	Placebo Blinded subjects will be randomized to placebo Placebo: Saline injection
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Short-Term Application of Tocilizumab Following Myocardial Infarction

Baseline characteristics by cohort

Measure	Tocilizumab n=12 Participants Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once. Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)	Placebo n=16 Participants Blinded subjects will be randomized to placebo Placebo: Saline injection	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	70.7 years STANDARD_DEVIATION 10.0 • n=5 Participants	67.7 years STANDARD_DEVIATION 9.5 • n=7 Participants	69.2 years STANDARD_DEVIATION 9.8 • 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	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized African American (Black)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian (White)	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after one time injection

Population: Major Adverse Cardiac Events (MACE) for those gathered 30 days after receiving medication or placebo

30 day rate of major adverse cardiac events (MACE) following administration of Tocilizumab subcutaneously single dose within 24 hours of NSTEMI or STEMI as compared to administration of placebo

Outcome measures

Measure	Tocilizumab n=9 Participants Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once. Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)	Placebo n=3 Participants Blinded subjects will be randomized to placebo Placebo: Saline injection
Number of Participants With Major Adverse Cardiovascular Events (MACE) Death	0 Participants	0 Participants
Number of Participants With Major Adverse Cardiovascular Events (MACE) Recurrent Myocardial Infarction	2 Participants	1 Participants
Number of Participants With Major Adverse Cardiovascular Events (MACE) Dysrhythmia	2 Participants	1 Participants
Number of Participants With Major Adverse Cardiovascular Events (MACE) Septal/Valve Rupture	1 Participants	1 Participants
Number of Participants With Major Adverse Cardiovascular Events (MACE) Pericarditis	2 Participants	0 Participants
Number of Participants With Major Adverse Cardiovascular Events (MACE) Cardiac Tamponade	2 Participants	0 Participants

Adverse Events

Tocilizumab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tocilizumab n=11 participants at risk Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once. Tocilizumab: 162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)	Placebo n=16 participants at risk Blinded subjects will be randomized to placebo Placebo: Saline injection
Cardiac disorders Symptomatic bradycardia	0.00% 0/11 • Major adverse cardiac event (MACE) rate consisting of several outcomes reported herein were collected 30 days after enrollment Information was collected from direct assessment, follow-up phone interview, and record review.	6.2% 1/16 • Number of events 1 • Major adverse cardiac event (MACE) rate consisting of several outcomes reported herein were collected 30 days after enrollment Information was collected from direct assessment, follow-up phone interview, and record review.
Cardiac disorders Symptomatic Hypotension	0.00% 0/11 • Major adverse cardiac event (MACE) rate consisting of several outcomes reported herein were collected 30 days after enrollment Information was collected from direct assessment, follow-up phone interview, and record review.	6.2% 1/16 • Number of events 1 • Major adverse cardiac event (MACE) rate consisting of several outcomes reported herein were collected 30 days after enrollment Information was collected from direct assessment, follow-up phone interview, and record review.
General disorders Gross Hematuria	9.1% 1/11 • Number of events 1 • Major adverse cardiac event (MACE) rate consisting of several outcomes reported herein were collected 30 days after enrollment Information was collected from direct assessment, follow-up phone interview, and record review.	0.00% 0/16 • Major adverse cardiac event (MACE) rate consisting of several outcomes reported herein were collected 30 days after enrollment Information was collected from direct assessment, follow-up phone interview, and record review.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew B. Carroll

United States Air Force

Phone: 228-376-3829

Email: mcar100210@yahoo.com

Results disclosure agreements

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