A Study of the Safety and Efficacy of Nitric Oxide Reduction in Patients With Cardiogenic Shock After a Heart Attack

NCT00112281 | Terminated Phase 3

• 1 other identifier: ARG-CS3-001
• Study Type: interventional
• Target: 658
• Locations: 2 countries
• Sites: 102

Brief Summary

Tilarginine Acetate Injection is a new type of drug that temporarily stops the body from making a bodily substance called nitric oxide. The body may produce excess nitric oxide following severe heart damage leading to shock. During a heart attack, and especially after a blocked artery causing the heart attack is reopened, a large amount of nitric oxide is released into the heart muscle and into the blood. Normally small amounts of nitric oxide are good for the heart and blood vessels. However, when released in large amounts, such as during a heart attack, it may be harmful, by adding to the damage of the heart attack and lowering the heart's ability to pump blood to the body. It may cause blood pressure to be lowered and reduce the amount of blood flow to the body's vital organs. This may interfere with the body's organs being able to do their work. If Tilarginine Acetate Injection can stop extra nitric oxide from being made, the performance of the heart and blood flow to the organs may get better, which may result in the improvement of symptoms. The purpose of this study (TRIUMPH) is to investigate the safety and effectiveness of Tilarginine Acetate Injection compared to placebo (an inactive fluid that has no effect on the body but looks exactly like the medication being studied). The study will help determine whether Tilarginine Acetate Injection, by temporarily lowering the amount of nitric oxide released into the vital organs can improve blood pressure and the blood flow to the body's organs.

Conditions

Shock, Cardiogenic

Keywords

shock, cardiogenic, "myocardial infarction"

Outcome Measures

Primary Outcomes (1)

• All cause mortality at 30 days post randomization

Secondary Outcomes (2)

• Number of patients demonstrating resolution of cardiogenic shock compared to placebo

• The duration of cardiogenic shock compared to placebo

Interventions

Tilarginine Acetate Injection intravenous infusion DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed myocardial infarction (heart attack)
• Confirmed persistent cardiogenic shock
• Confirmed patency of the infarct related artery (heart attack artery has been opened through the use of a blood clot dissolving drug or a balloon or angioplasty heart procedure)
• Less than 24 hour duration of cardiogenic shock (the time since the heart attack occurred and the artery was opened must be less than 24 hours)

You may not qualify if:

• Infection
• Other cause of shock (not heart attack)
• Shock due to heart valve disease
• Severe heart valve disease
• Right sided heart failure
• Shock due to arrhythmia (irregular heart rhythm)
• Severe kidney disease
• Aortic dissection (tear in aorta)
• Adult respiratory distress syndrome (ARDS) (severe lung inflammation)
• Severe brain damage
• Severe irreversible multi-system failure (failure of multiple body organs)
• Major chest or abdominal surgical procedure within 30 days except if prior CABG and reocclusion occurs
• Primary pulmonary hypertension (high blood pressure in the arteries of the lungs)
• Age younger than 18 years
• Requirement for emergency coronary artery bypass grafting (CABG) or infarct-related artery occlusion (heart attack artery completely blocked)

Sponsors & Collaborators

• Arginox Pharmaceuticals: lead

Study Sites (102)

The Heart Group, PC

Mobile, Alabama, 36608, United States

Location

Sparks Regional Medical Center

Fort Smith, Arizona, 72901, United States

Location

Banner Baywood Heart Hospital

Mesa, Arizona, 85206, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85043, United States

Location

Central Arkansas Cardiovascular Research Group (CACRG)

Little Rock, Arkansas, 72205, United States

Location

Los Angeles Cardiology Associates

Los Angeles, California, 90017, United States

Location

University of Southern California, LAC + USC Medical Center

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University School of Medicine

Palo Alto, California, 94305-5406, United States

Location

Desert Cardiology

Rancho Mirage, California, 92270, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

South Denver Cardiology Associates, PC

Littleton, Colorado, 80120, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010-2975, United States

Location

Florida Cardiovascular Research Center

Atlantis, Florida, 33462, United States

Location

Watson Clinic, LLP

Lakeland, Florida, 33805, United States

Location

Health First Clinical Research Institute

Melbourne, Florida, 32901, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Mt. Sinai Medical Center

Miami, Florida, 33140, United States

Location

Mediquest Research Group

Ocala, Florida, 34471, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Cardiovascular Center of Sarasota

Sarasota, Florida, 34239, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Heart Care Midwest

Peoria, Illinois, 61603, United States

Location

Trinity Medical Center

Rock Island, Illinois, 61201, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46805, United States

Location

Iowa Health, Des Moines

Des Moines, Iowa, 50309, United States

Location

Iowa Heart Centre

Des Moines, Iowa, 50314, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40536-0200, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Northeast Cardiology Associates

Bangor, Maine, 04401, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Interventional Cardiovascular Research - Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Fallon Cardiology - St. Vincent Hospital

Worchester, Massachusetts, 01608, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109-0311, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49525, United States

Location

Nisus Research at Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073-6769, United States

Location

St. Mary's Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

BryanLGH Heart Institute

Lincoln, Nebraska, 68516, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-2265, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Lenox Hill Heart and Vascular Institute of New York

New York, New York, 10021, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Rochester Cardio-Pulmonary Group, P.C.

Rochester, New York, 14621, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cardiology Associates of Schenectady

Schenectady, New York, 12309, United States

Location

Mission Hospitals

Asheville, North Carolina, 28801, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599-7075, United States

Location

Sanger Clinic

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

LeBauer Cardiovascular Research

Greensboro, North Carolina, 27401, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MidWest Cardiology Research Foundation

Columbus, Ohio, 43214, United States

Location

The Oregon Clinic

Portland, Oregon, 97213-2281, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

The Heart Care Group

Allentown, Pennsylvania, 18106, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17603, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Guthrie Clinic

Sayre, Pennsylvania, 18830, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

Johnson City Medical Center

Johnson City, Tennessee, 37601, United States

Location

St. Thomas Cardiology Consultants

Nashville, Tennessee, 37205, United States

Location

Ben Taub General Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas Medical School

Houston, Texas, 77030, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Fletcher Allen Healthcare

Burlington, Vermont, 05401, United States

Location

Calgary Heart Centre Alberta

Calgary, Alberta, T2N 2T9, Canada

Location

Royal Alexandria Hospital

Edmonton, Alberta, T5H3V9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver Hospital and Health Sciences Centre

Vancouver, British Columbia, V5Z 1L8, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Victoria Heart Institute Foundation

Victoria, British Columbia, V8R 4R2, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

NB Heart Centre

Saint John, New Brunswick, E2L 4L2, Canada

Location

Cardiology Research - QEII Health Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

QEII Health Science Centre - Cardiology Research

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences, General Site

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Trilium Health Centre

Mississauga, Ontario, L5B 2P7, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2R2, Canada

Location

University of Ottawa

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Quebec Heart Institute

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• TRIUMPH Investigators; Alexander JH, Reynolds HR, Stebbins AL, Dzavik V, Harrington RA, Van de Werf F, Hochman JS. Effect of tilarginine acetate in patients with acute myocardial infarction and cardiogenic shock: the TRIUMPH randomized controlled trial. JAMA. 2007 Apr 18;297(15):1657-66. doi: 10.1001/jama.297.15.joc70035. Epub 2007 Mar 26.

  PMID: 17387132 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic; Shock; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Judith S. Hochman, M.D.

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 1, 2005
• First Posted: June 2, 2005
• Study Start: May 1, 2005
• Study Completion: January 1, 2007
• Last Updated: August 4, 2006

Record last verified: 2005-05

Locations

CA (19); US (83)