Clinical Trials

Toll-Free: 866.320.4573

Call Us Toll Free:

866.223.2273 x1234

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

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

Cleveland Clinic Mobile Site