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Shock, CardiogenicPhase 3NCT00112281

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

A Phase 3 study testing Tilarginine Acetate Injection intravenous infusion in people with Shock, Cardiogenic, run by Arginox Pharmaceuticals at 102 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Cardiogenic
What is being tested?
Tilarginine Acetate Injection intravenous infusion
Type of treatment
Injection or infusion
How many people
658 participants
Where
102 sitesin 2 countries
Study dates
May 2005to Jan 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 18Show fewer
  • 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

Trial locations and contacts

102 sites in 2 countries.

102 sites in 2 countries

United States83 sites

  • The Heart Care Group

    Allentown, Pennsylvania, 18106

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-0311

  • Mission Hospitals

    Asheville, North Carolina, 28801

  • Emory Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Florida Cardiovascular Research Center

    Atlantis, Florida, 33462

  • Northeast Cardiology Associates

    Bangor, Maine, 04401

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Interventional Cardiovascular Research - Lahey Clinic

    Burlington, Massachusetts, 01805

  • Fletcher Allen Healthcare

    Burlington, Vermont, 05401

  • Cooper Health System

    Camden, New Jersey, 08103

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599-7075

  • Sanger Clinic

    Charlotte, North Carolina, 28203

  • John H. Stroger Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • MidWest Cardiology Research Foundation

    Columbus, Ohio, 43214

  • Iowa Health, Des Moines

    Des Moines, Iowa, 50309

  • Iowa Heart Centre

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. Mary's Duluth Clinic Health System

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Sparks Regional Medical Center

    Fort Smith, Arizona, 72901

  • Parkview Research Center

    Fort Wayne, Indiana, 46805

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49525

  • LeBauer Cardiovascular Research

    Greensboro, North Carolina, 27401

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Ben Taub General Hospital, Baylor College of Medicine

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Medical School

    Houston, Texas, 77030

  • University of Iowa Hospital

    Iowa City, Iowa, 52242

  • Johnson City Medical Center

    Johnson City, Tennessee, 37601

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Watson Clinic, LLP

    Lakeland, Florida, 33805

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17603

  • University of Kentucky

    Lexington, Kentucky, 40536-0200

  • BryanLGH Heart Institute

    Lincoln, Nebraska, 68516

  • Central Arkansas Cardiovascular Research Group (CACRG)

    Little Rock, Arkansas, 72205

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • Los Angeles Cardiology Associates

    Los Angeles, California, 90017

  • University of Southern California, LAC + USC Medical Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Health First Clinical Research Institute

    Melbourne, Florida, 32901

  • Banner Baywood Heart Hospital

    Mesa, Arizona, 85206

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Mt. Sinai Medical Center

    Miami, Florida, 33140

  • The Heart Group, PC

    Mobile, Alabama, 36608

  • St. Thomas Cardiology Consultants

    Nashville, Tennessee, 37205

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Lenox Hill Heart and Vascular Institute of New York

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Mediquest Research Group

    Ocala, Florida, 34471

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2265

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

  • Stanford University School of Medicine

    Palo Alto, California, 94305-5406

  • Heart Care Midwest

    Peoria, Illinois, 61603

  • Nisus Research at Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85043

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Maine Medical Center

    Portland, Maine, 04102

  • The Oregon Clinic

    Portland, Oregon, 97213-2281

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Desert Cardiology

    Rancho Mirage, California, 92270

  • Mayo Clinic Minnesota

    Rochester, Minnesota, 55905

  • Rochester Cardio-Pulmonary Group, P.C.

    Rochester, New York, 14621

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Trinity Medical Center

    Rock Island, Illinois, 61201

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6769

  • Mercy General Hospital

    Sacramento, California, 95819

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Guthrie Clinic

    Sayre, Pennsylvania, 18830

  • Cardiology Associates of Schenectady

    Schenectady, New York, 12309

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University

    St Louis, Missouri, 63110

  • Washington Hospital Center

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

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • Fallon Cardiology - St. Vincent Hospital

    Worchester, Massachusetts, 01608

Other trials in United States

Canada19 sites

  • Calgary Heart Centre Alberta

    Calgary, Alberta, T2N 2T9

  • Royal Alexandria Hospital

    Edmonton, Alberta, T5H3V9

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • Cardiology Research - QEII Health Science Centre

    Halifax, Nova Scotia, B3H 3A7

  • QEII Health Science Centre - Cardiology Research

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton Health Sciences, General Site

    Hamilton, Ontario, L8L 2X2

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Trilium Health Centre

    Mississauga, Ontario, L5B 2P7

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2R2

  • University of Ottawa

    Ottawa, Ontario, K1Y 4W7

  • Quebec Heart Institute

    Québec, Quebec, G1V 4G5

  • NB Heart Centre

    Saint John, New Brunswick, E2L 4L2

  • St. Michael's Hospital Toronto

    Toronto, Ontario, M5B 1W8

  • University Health Network - Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Vancouver Hospital and Health Sciences Centre

    Vancouver, British Columbia, V5Z 1L8

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Tilarginine Acetate Injection intravenous infusion
Keywords
shock, cardiogenic, "myocardial infarction"
Medical subject headings
Shock, Cardiogenic, Shock, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tilarginine Acetate Injection intravenous infusionDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality at 30 days post randomization

Secondary outcomes (2)

  1. Number of patients demonstrating resolution of cardiogenic shock compared to placebo

  2. The duration of cardiogenic shock compared to placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2005 (estimated)
  2. Study startMay 2005
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
658 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112281
Sponsor's protocol ID
ARG-CS3-001
Status last verified
May 2005
First submitted
1 Jun 2005
Last updated
4 Aug 2006
Results posted
No

Publications

  • 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.

    PubMed 17387132

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tilarginine Acetate Injection intravenous infusion in people with Shock, Cardiogenic, run by Arginox Pharmaceuticals at 102 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality at 30 days post randomization. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00112281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2006.

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