Trial Outcomes & Findings for Sodium Nitrite in Acute Myocardial Infarction (NCT NCT00924118)
NCT ID: NCT00924118
Last Updated: 2018-05-14
Results Overview
Measured as percentage of left ventricle
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
4-5 days from enrollment
Results posted on
2018-05-14
Participant Flow
Participant milestones
| Measure |
Sodium Nitrite
Dose escalation of sodium nitrite.
Sodium Nitrite: 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.
|
Open Control
Subjects randomized to open control will receive no experimental therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sodium Nitrite in Acute Myocardial Infarction
Baseline characteristics by cohort
| Measure |
Sodium Nitrite
n=15 Participants
Dose escalation of sodium nitrite.
Sodium Nitrite: 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.
|
Open Control
n=15 Participants
Subjects randomized to open control will receive no experimental therapy.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
59.6 years
n=5 Participants
|
59.2 years
n=7 Participants
|
59.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-5 days from enrollmentPopulation: Sestamibi imaging proved impossible to obtain emergently and therefore no data was collected.
Measured as percentage of left ventricle
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4-5 days following enrollmentPopulation: Only 2 participants from each arm underwent MRI imaging. Too few subjects underwent MRI imaging to make a statistical comparison. Only those where data was obtained has been reported.
Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.
Outcome measures
| Measure |
Sodium Nitrite
n=2 Participants
Dose escalation of sodium nitrite.
Sodium Nitrite: 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.
|
Open Control
n=2 Participants
Subjects randomized to open control will receive no experimental therapy.
|
|---|---|---|
|
Left Ventricular Infarct Size
|
15.5 infarct percentage of left ventricle
Interval 7.0 to 17.0
|
24 infarct percentage of left ventricle
Interval 17.0 to 31.0
|
Adverse Events
Sodium Nitrite
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sodium Nitrite
n=15 participants at risk
Dose escalation of sodium nitrite.
Sodium Nitrite: 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.
|
Open Control
n=15 participants at risk
Subjects randomized to open control will receive no experimental therapy.
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
26.7%
4/15 • Number of events 4 • 7 years
|
0.00%
0/15 • 7 years
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • 7 years
|
0.00%
0/15 • 7 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place