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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00112281 |
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Date of registration:
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01/06/2005 |
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Primary sponsor: |
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Public title:
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A Study of the Safety and Efficacy of Nitric Oxide Reduction in Patients With Cardiogenic Shock After a Heart Attack
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Scientific title:
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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 |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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658 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00112281 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Judith S. Hochman, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York University School of Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Shock, Cardiogenic
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Intervention(s)
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Drug: Tilarginine Acetate Injection intravenous infusion
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Primary Outcome(s)
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All cause mortality at 30 days post randomization
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Secondary Outcome(s)
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Number of patients demonstrating resolution of cardiogenic shock compared to placebo
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The duration of cardiogenic shock compared to placebo
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Secondary ID(s)
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ARG-CS3-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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