CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Sodium Nitritedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00924118
NCT00924118Phase 2Completed
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A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Prevention of Ischemia-Reperfusion Injury Associated With Acute Myocardial Infarction.

Johns Hopkins University·interventional·Posted Jun 18, 2009·Updated May 14, 2018

In Brief

A Phase 2 clinical trial evaluating Sodium Nitrite for Acute Myocardial Infarction. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

The purpose of this study is to determine whether the intravenous infusion of sodium nitrite safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction resulting in improved left ventricular function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocardial Infarction
CountriesUnited States
CollaboratorsHope Pharmaceuticals

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 18, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 17.0 years ago

Interventions

Sodium Nitritedrug

Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.