Trial Outcomes & Findings for A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function (NCT NCT03357731)
NCT ID: NCT03357731
Last Updated: 2020-07-27
Results Overview
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
at the end of the 5-hour infusion
Results posted on
2020-07-27
Participant Flow
49 participants assigned to treatment and 45 treated. Reasons not treated: 2 re-randomized; 1 randomized in error, screen failure; 1 no longer met study criteria. Note: Study designed for all participants to enter all 3 arms (reassignment of arms occurs every period change).
Participant milestones
| Measure |
Sequence 1
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: PBO-drug-NTG
|
Sequence 2
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: PBO-NTG-drug
|
Sequence 3
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: NTG-PBO-drug
|
Sequence 4
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: NTG-drug-PBO
|
Sequence 5
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: drug-PBO-NTG
|
Sequence 6
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: drug-NTG-PBO
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
7
|
7
|
8
|
8
|
|
Overall Study
Completed Period 1 (P1)
|
8
|
7
|
7
|
6
|
7
|
8
|
|
Overall Study
Completed Period 2 (P2)
|
8
|
7
|
7
|
4
|
7
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
6
|
4
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: PBO-drug-NTG
|
Sequence 2
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: PBO-NTG-drug
|
Sequence 3
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: NTG-PBO-drug
|
Sequence 4
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: NTG-drug-PBO
|
Sequence 5
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: drug-PBO-NTG
|
Sequence 6
Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period.
3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG)
Sequence of treatment for this group is as follows: drug-NTG-PBO
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrew consent due to personal reasons
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Acute bradycardia and hypotension
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Hypotension
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
Baseline characteristics by cohort
| Measure |
Overall Participants
n=45 Participants
Inclusive of all treatments, all periods. Note: Participants crossed-over from either placebo, drug or NTG arm to the next (in various sequence) following Day 1 treatment and a minimum 5-day washout period, per arm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=93 Participants
|
|
Age, Continuous
|
63.7 Years
STANDARD_DEVIATION 12.35 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: at the end of the 5-hour infusionPopulation: Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period.
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo.
Outcome measures
| Measure |
Placebo (PBO)
n=39 Participants
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=37 Participants
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Mean Stroke Volume Index (SVI) Derived From the Velocity Time Integral at the Left Ventricular Outflow Tract (LVOT VTI) at the End of the 5-hour Infusion of BMS-986231, Versus Placebo
|
29.545 mL/m^2
Standard Deviation 7.0243
|
28.721 mL/m^2
Standard Deviation 9.0174
|
—
|
SECONDARY outcome
Timeframe: at the end of the 5-hour infusionPopulation: Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period.
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to NTG.
Outcome measures
| Measure |
Placebo (PBO)
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=37 Participants
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=41 Participants
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Mean SVI Derived From LVOT VTI at the End of the 5-hour Infusion of BMS-986231, Versus NTG
|
—
|
28.721 mL/m^2
Standard Deviation 9.0174
|
27.811 mL/m^2
Standard Deviation 7.9712
|
SECONDARY outcome
Timeframe: at the end of the 5-hour infusionPopulation: Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period.
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: LV ejection fraction
Outcome measures
| Measure |
Placebo (PBO)
n=38 Participants
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=36 Participants
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=42 Participants
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Mean LVEF, Computed by Simpson's Method at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
|
31.9 Percentage of blood pumped from the LV
Standard Deviation 7.15
|
32.8 Percentage of blood pumped from the LV
Standard Deviation 8.24
|
33.5 Percentage of blood pumped from the LV
Standard Deviation 7.33
|
SECONDARY outcome
Timeframe: at the end of the 5-hour infusionPopulation: Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period.
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Mean LV power index
Outcome measures
| Measure |
Placebo (PBO)
n=35 Participants
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=36 Participants
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=39 Participants
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Mean Cardiac Power Index at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
|
0.4122 watts per square meter (W/m^2)
Standard Deviation 0.14404
|
0.3427 watts per square meter (W/m^2)
Standard Deviation 0.10463
|
0.3568 watts per square meter (W/m^2)
Standard Deviation 0.09184
|
SECONDARY outcome
Timeframe: at the end of the 5-hour infusionPopulation: Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period.
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Diastolic function
Outcome measures
| Measure |
Placebo (PBO)
n=37 Participants
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=34 Participants
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=40 Participants
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Mean Diastolic Indices: E/A and E/e' Ratio at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
E/A ratio
|
0.80 Ratio
Standard Deviation 0.278
|
0.73 Ratio
Standard Deviation 0.270
|
0.71 Ratio
Standard Deviation 0.310
|
|
Mean Diastolic Indices: E/A and E/e' Ratio at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
E/e' ratio
|
9.42 Ratio
Standard Deviation 4.102
|
7.00 Ratio
Standard Deviation 2.464
|
7.81 Ratio
Standard Deviation 2.652
|
SECONDARY outcome
Timeframe: at the end of the 5-hour infusionPopulation: Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period.
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Diastolic function
Outcome measures
| Measure |
Placebo (PBO)
n=37 Participants
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=34 Participants
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=40 Participants
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Mean Diastolic Indices: Annular e' Velocity at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
|
7.18 cm/sec
Standard Deviation 2.467
|
8.07 cm/sec
Standard Deviation 2.333
|
7.18 cm/sec
Standard Deviation 2.143
|
SECONDARY outcome
Timeframe: at the end of the 5-hour infusionPopulation: Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period.
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: LV global longitudinal strain
Outcome measures
| Measure |
Placebo (PBO)
n=38 Participants
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=36 Participants
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=43 Participants
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Mean LV Global Longitudinal Strain, Computed Using STE at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
|
-11.98 Percentage of blood pumped from the LV
Standard Deviation 2.860
|
-11.94 Percentage of blood pumped from the LV
Standard Deviation 3.458
|
-11.36 Percentage of blood pumped from the LV
Standard Deviation 3.067
|
Adverse Events
Placebo (PBO)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
BMS-986231
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Nitroglycerin (NTG)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (PBO)
n=40 participants at risk
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=42 participants at risk
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=44 participants at risk
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • From first dose to 30 days post last dose (approximately 3 months)
|
0.00%
0/42 • From first dose to 30 days post last dose (approximately 3 months)
|
0.00%
0/44 • From first dose to 30 days post last dose (approximately 3 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • From first dose to 30 days post last dose (approximately 3 months)
|
0.00%
0/42 • From first dose to 30 days post last dose (approximately 3 months)
|
2.3%
1/44 • From first dose to 30 days post last dose (approximately 3 months)
|
Other adverse events
| Measure |
Placebo (PBO)
n=40 participants at risk
Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
BMS-986231
n=42 participants at risk
BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion.
Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
Nitroglycerin (NTG)
n=44 participants at risk
NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm.
Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows:
PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.0%
2/40 • From first dose to 30 days post last dose (approximately 3 months)
|
23.8%
10/42 • From first dose to 30 days post last dose (approximately 3 months)
|
15.9%
7/44 • From first dose to 30 days post last dose (approximately 3 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • From first dose to 30 days post last dose (approximately 3 months)
|
11.9%
5/42 • From first dose to 30 days post last dose (approximately 3 months)
|
6.8%
3/44 • From first dose to 30 days post last dose (approximately 3 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60