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

August 2, 2006 updated by: Arginox Pharmaceuticals

A Phase III International, Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Nitric Oxide Synthase Inhibition With Tilarginine Acetate Injection in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction, or the TRIUMPH Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

An estimated 120,000 to 160,000 patients annually are diagnosed with cardiogenic shock (CS) in North America and Europe. CS complicates approximately 5-14% of all cases of acute myocardial infarction (AMI) and is the most common cause of death in patients hospitalized with AMI. Cardiogenic shock developing during the course of AMI is the end result of a pathophysiological cycle secondary to a sudden and significant decrease in cardiac contractility due to infarction, ischemia, and stunning of large myocardial segments. It is not anticipated that further advances in reperfusion or revascularization therapy will have a significant additional impact on survival in patients with CS. Modalities that protect the myocardium during ischemia and reperfusion are likely to be the next major advance in improving outcome in the setting of acute myocardial infarction (MI), especially in patients with large infarcts complicated by shock. Preliminary studies investigating nitric oxide synthase (NOS) inhibition suggest that improvements in cardiovascular function and survival are possible by limiting formation of toxic NO. The primary objective of the TRIUMPH study is to establish the efficacy of Tilarginine Acetate Injection compared to placebo in reducing all cause mortality at 30 days post randomization in patients with cardiogenic shock complicating acute myocardial infarction (MI). Safety objectives of this study include an evaluation of adverse events and serious adverse events, and key laboratory parameters.

Study Type

Interventional

Enrollment

658

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Quebec Heart Institute
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Calgary Heart Centre Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
      • Edmonton, Alberta, Canada, T5H3V9
        • Royal Alexandria Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada, V5Z 1L8
        • Vancouver Hospital and Health Sciences Centre
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Heart Institute Foundation
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • New Brunswick
      • St. John, New Brunswick, Canada, E2L 4L2
        • NB Heart Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Cardiology Research - QEII Health Science Centre
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Science Centre - Cardiology Research
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences, General Site
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • Mississauga, Ontario, Canada, L5B 2P7
        • Trilium Health Centre
      • Newmarket, Ontario, Canada, L3Y 2R2
        • Southlake Regional Health Centre
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network - Toronto General Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital Toronto
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • The Heart Group, PC
    • Arizona
      • Fort Smith, Arizona, United States, 72901
        • Sparks Regional Medical Center
      • Mesa, Arizona, United States, 85206
        • Banner Baywood Heart Hospital
      • Phoenix, Arizona, United States, 85043
        • Mayo Clinic Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Cardiovascular Research Group (CACRG)
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90017
        • Los Angeles Cardiology Associates
      • Los Angeles, California, United States, 90033
        • University of Southern California, LAC + USC Medical Center
      • Palo Alto, California, United States, 94305-5406
        • Stanford University School of Medicine
      • Rancho Mirage, California, United States, 92270
        • Desert Cardiology
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates, PC
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2975
        • Washington Hospital Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • Florida Cardiovascular Research Center
      • Lakeland, Florida, United States, 33805
        • Watson Clinic, LLP
      • Melbourne, Florida, United States, 32901
        • Health First Clinical Research Institute
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Miami, Florida, United States, 33140
        • Mt. Sinai Medical Center
      • Ocala, Florida, United States, 34471
        • Mediquest Research Group
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center of Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Crawford Long Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger Jr. Hospital of Cook County
      • Peoria, Illinois, United States, 61603
        • Heart Care Midwest
      • Rock Island, Illinois, United States, 61201
        • Trinity Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Research Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Iowa Health, Des Moines
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Centre
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University Of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0200
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maine
      • Bangor, Maine, United States, 04401
        • Northeast Cardiology Associates
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Burlington, Massachusetts, United States, 01805
        • Interventional Cardiovascular Research - Lahey Clinic
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
      • Worchester, Massachusetts, United States, 01608
        • Fallon Cardiology - St. Vincent Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0311
        • University of Michigan Health Systems
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49525
        • Spectrum Health Hospitals
      • Petoskey, Michigan, United States, 49770
        • Nisus Research at Northern Michigan Hospital
      • Royal Oak, Michigan, United States, 48073-6769
        • William Beaumont Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's Duluth Clinic Health System
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
      • St. Louis, Missouri, United States, 63110
        • Saint Louis University
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • BryanLGH Heart Institute
      • Omaha, Nebraska, United States, 68198-2265
        • University of Nebraska Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Health System
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10021
        • Lenox Hill Heart and Vascular Institute of New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14621
        • Rochester Cardio-Pulmonary Group, P.C.
      • Schenectady, New York, United States, 12309
        • Cardiology Associates of Schenectady
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospitals
      • Chapel Hill, North Carolina, United States, 27599-7075
        • UNC Chapel Hill
      • Charlotte, North Carolina, United States, 28203
        • Sanger Clinic
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27401
        • LeBauer Cardiovascular Research
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43214
        • MidWest Cardiology Research Foundation
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart & Vascular Institute
      • Portland, Oregon, United States, 97213-2281
        • The Oregon Clinic
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18106
        • The Heart Care Group
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17603
        • Lancaster General Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Sayre, Pennsylvania, United States, 18830
        • Guthrie Clinic
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Johnson City Medical Center
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Cardiology Consultants
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • University of Texas Medical School
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital, Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • Ongoing or recent participation in another clinical trial of an investigational drug
  • Prior enrollment in this study or rapid resolution of cardiogenic shock before treatment (shock gets better before study starts)
  • Positive pregnancy test in women who are of childbearing potential

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
All cause mortality at 30 days post randomization

Secondary Outcome Measures

Outcome Measure
Number of patients demonstrating resolution of cardiogenic shock compared to placebo
The duration of cardiogenic shock compared to placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arginox Pharmaceuticals

Investigators

  • Study Chair: Judith S. Hochman, M.D., NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

June 1, 2005

First Submitted That Met QC Criteria

June 1, 2005

First Posted (Estimate)

June 2, 2005

Study Record Updates

Last Update Posted (Estimate)

August 4, 2006

Last Update Submitted That Met QC Criteria

August 2, 2006

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARG-CS3-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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