Trial Outcomes & Findings for Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction (NCT NCT01936896)

Results Overview

A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

14 days

Results posted on

2016-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Alpha-1 Anti-trypsin (AAT) Plasma derived Alpha 1-Antitrypsin (AAT) 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alpha-1 Anti-trypsin (AAT) n=10 Participants Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	52.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.

Outcome measures

Outcome measures
Measure	Alpha-1 Anti-trypsin (AAT) n=10 Participants Plasma derived AAT 60 mg/Kg, single infusion
C Reactive Protein (Area Under the Curve)	75.9 mg/L Interval 31.4 to 147.8

SECONDARY outcome

Timeframe: 3 months

Population: Only 5 patients had paired (i.e. baseline and 3 months) echocardiograms for evaluation

We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography

Outcome measures

Outcome measures
Measure	Alpha-1 Anti-trypsin (AAT) n=5 Participants Plasma derived AAT 60 mg/Kg, single infusion
Left Ventricular End-systolic Volume Change	2 mL Interval -6.0 to 19.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.

Outcome measures

Outcome data not reported

Adverse Events

Alpha-1 Anti-trypsin (AAT)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alpha-1 Anti-trypsin (AAT) n=10 participants at risk Plasma derived AAT 60 mg/Kg, single infusion
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	10.0% 1/10 • Number of events 1
Cardiac disorders Sudden death	10.0% 1/10 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Antonio Abbate

Virginia Commonwealth University

Phone: 8048280513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place