Trial Outcomes & Findings for Anakinra to Prevent Post-infarction Remodeling (NCT NCT00789724)

NCT ID: NCT00789724

Last Updated: 2017-11-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: 10-14 weeks
• Results posted on: 2017-11-30

Participant Flow

Enrollment started in November 2008. During the first 4 months, 33 patients admitted with STEMI were screened and 10 patients were enrolled. One patient withdrew consent to the study on day 2 prior to all assessment and was excluded. The Institutional Review Board then approved enrollment of an additional patient who was enrolled in May 2009.

Participant milestones

Measure	Anakinra Anakinra 100 mg given daily by subcutaneous injection for 14 days	Placebo 0.67 ml of NaCl 0.9% solution
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anakinra to Prevent Post-infarction Remodeling

Baseline characteristics by cohort

Measure	Anakinra n=5 Participants Anakinra 100 mg given daily by subcutaneous injection for 14 days	Placebo n=5 Participants 0.67 ml of NaCl 0.9% solution	Total n=10 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 13 • n=5 Participants	52 years STANDARD_DEVIATION 15 • n=7 Participants	48 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 10-14 weeks

Outcome measures

Measure	Anakinra n=5 Participants Anakinra 100 mg given daily by subcutaneous injection for 14 days	Placebo n=5 Participants 0.67 ml of NaCl 0.9% solution
Difference Between the Anakinra Arm and Placebo Arm in Change in End-systolic Volume Indices From Baseline to Follow up Exam 10-14 Weeks Later at Cardiac Magnetic Resonance Imaging.	-3.2 mL/m2 Interval -4.5 to -1.2	2.0 mL/m2 Interval 1.0 to 11.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 10-14 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10-14 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10-14 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10-14 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10-14 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10-14 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10-14 weeks

Outcome measures

Outcome data not reported

Adverse Events

Anakinra

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anakinra n=5 participants at risk Anakinra 100 mg given daily by subcutaneous injection for 14 days	Placebo n=5 participants at risk 0.67 ml of NaCl 0.9% solution
Cardiac disorders Recurrent acute coronary syndrome	40.0% 2/5 • Number of events 2 • 3 months	40.0% 2/5 • Number of events 2 • 3 months
Cardiac disorders Congestive Heart Failure	0.00% 0/5 • 3 months	40.0% 2/5 • Number of events 2 • 3 months

Other adverse events

Measure	Anakinra n=5 participants at risk Anakinra 100 mg given daily by subcutaneous injection for 14 days	Placebo n=5 participants at risk 0.67 ml of NaCl 0.9% solution
Skin and subcutaneous tissue disorders Injection site pain	40.0% 2/5 • Number of events 2 • 3 months	0.00% 0/5 • 3 months

Additional Information

Antonio Abbate, MD, PhD

VCU Pauley Heart Center

Phone: 8048280513

Email: aabbate@mcvh-vcu.edu

Results disclosure agreements

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