Study:
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
Rationale:
n/a
Purpose:
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 Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Shock, Cardiogenic |
Drug: Tilarginine Acetate Injection intravenous infusion |
Phase 3 |
Verified by
Arginox Pharmaceuticals
May, 2005
Sponsored by: Arginox Pharmaceuticals
Information provided by: Arginox Pharmaceuticals
ClinicalTrials.gov identifier: NCT00112281
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Judith S. Hochman, M.D.., Study Chair