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

NCT ID: NCT01936896

Last Updated: 2016-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-07-31

Brief Summary

Acute myocardial infarction is characterized by an intense inflammatory response.

The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alpha-1 anti-trypsin (AAT)

We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)

Group Type: EXPERIMENTAL

Alpha 1-Antitrypsin

Intervention Type: DRUG

Interventions

Alpha 1-Antitrypsin

Intervention Type: DRUG

Other Intervention Names

Prolastin C; Aralast NP

Eligibility Criteria

Inclusion Criteria

• Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new
• Planned or completed coronary angiogram for potential intervention
• Age>21

Exclusion Criteria

• Inability to give informed consent
• Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)
• Pregnancy
• Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
• Preexisting severe left ventricular dysfunction (EF<20%)
• Preexisting severe valvular heart disease
• Known active infections (acute or chronic)
• Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)
• Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
• Known active malignancy of any type, or prior diagnosis in the past 10 years
• Anticipated need for cardiac or major surgery
• Known active cancer (or prior diagnosis of cancer within the past 10 years)
• Known Immunoglobulin A (IgA) deficiency

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Abbate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Benjamin Van Tassell, PharmD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

Abouzaki NA, Christopher S, Trankle C, Van Tassell BW, Carbone S, Mauro AG, Buckley L, Toldo S, Abbate A. Inhibiting the Inflammatory Injury After Myocardial Ischemia Reperfusion With Plasma-Derived Alpha-1 Antitrypsin: A Post Hoc Analysis of the VCU-alpha1RT Study. J Cardiovasc Pharmacol. 2018 Jun;71(6):375-379. doi: 10.1097/FJC.0000000000000583.

Reference Type: DERIVED

PMID: 29634656 (View on PubMed)

Other Identifiers

HM15342

Identifier Type: -

Identifier Source: org_study_id