Status:
TERMINATED
A Study of the Safety and Efficacy of Nitric Oxide Reduction in Patients With Cardiogenic Shock After a Heart Attack
Lead Sponsor:
Arginox Pharmaceuticals
Conditions:
Shock, Cardiogenic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT00112281
Start Date
May 1 2005
End Date
January 1 2007
Last Update
August 4 2006
Active Locations (102)
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1
The Heart Group, PC
Mobile, Alabama, United States, 36608
2
Sparks Regional Medical Center
Fort Smith, Arizona, United States, 72901
3
Banner Baywood Heart Hospital
Mesa, Arizona, United States, 85206
4
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85043