Trial Outcomes & Findings for Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes" (NCT NCT02671461)

NCT ID: NCT02671461

Last Updated: 2018-12-14

Results Overview

The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

28 Days

Results posted on

2018-12-14

Participant Flow

16 participants were enrolled; 15 were randomized; 14 were treated. 1 participant was not randomized because the interactive voice response system did not work at the time of enrollment

Participant milestones

Participant milestones
Measure	Placebo Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141	BMS-986141 0.8 mg BMS-986141 0.8 mg QD for up to 28 days	BMS-986141 4.8 mg BMS-986141 4.8 mg QD for up to 28 days
Treatment STARTED	3	5	7
Treatment COMPLETED	1	2	2
Treatment NOT COMPLETED	2	3	5
Follow-up STARTED	2	5	7
Follow-up COMPLETED	1	4	6
Follow-up NOT COMPLETED	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141	BMS-986141 0.8 mg BMS-986141 0.8 mg QD for up to 28 days	BMS-986141 4.8 mg BMS-986141 4.8 mg QD for up to 28 days
Treatment Adverse Event	0	0	1
Treatment Administrative Reason by Sponsor	1	3	4
Treatment Randomized, not treated	1	0	0
Follow-up Withdrawal by Subject	1	0	0
Follow-up Lost to Follow-up	0	0	1
Follow-up Administrative Reason by Sponsor	0	1	0

Baseline Characteristics

All randomized participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=3 Participants Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141	BMS-986141 0.8 mg n=5 Participants BMS-986141 0.8 mg QD for up to 28 days	BMS-986141 4.8 mg n=7 Participants BMS-986141 4.8 mg QD for up to 28 days	Total n=15 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 9.2 • n=5 Participants • All randomized participants	64.8 years STANDARD_DEVIATION 12.2 • n=7 Participants • All randomized participants	66.7 years STANDARD_DEVIATION 7.6 • n=5 Participants • All randomized participants	65.4 years STANDARD_DEVIATION 9.0 • n=4 Participants • All randomized participants
Sex: Female, Male Female	1 Participants n=5 Participants • All randomized participants	1 Participants n=7 Participants • All randomized participants	3 Participants n=5 Participants • All randomized participants	5 Participants n=4 Participants • All randomized participants
Sex: Female, Male Male	2 Participants n=5 Participants • All randomized participants	4 Participants n=7 Participants • All randomized participants	4 Participants n=5 Participants • All randomized participants	10 Participants n=4 Participants • All randomized participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • All randomized participants	0 Participants n=7 Participants • All randomized participants	0 Participants n=5 Participants • All randomized participants	0 Participants n=4 Participants • All randomized participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants • All randomized participants	5 Participants n=7 Participants • All randomized participants	7 Participants n=5 Participants • All randomized participants	15 Participants n=4 Participants • All randomized participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All randomized participants	0 Participants n=7 Participants • All randomized participants	0 Participants n=5 Participants • All randomized participants	0 Participants n=4 Participants • All randomized participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • All randomized participants	0 Participants n=7 Participants • All randomized participants	0 Participants n=5 Participants • All randomized participants	0 Participants n=4 Participants • All randomized participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants • All randomized participants	0 Participants n=7 Participants • All randomized participants	1 Participants n=5 Participants • All randomized participants	1 Participants n=4 Participants • All randomized participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • All randomized participants	0 Participants n=7 Participants • All randomized participants	0 Participants n=5 Participants • All randomized participants	0 Participants n=4 Participants • All randomized participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • All randomized participants	2 Participants n=7 Participants • All randomized participants	1 Participants n=5 Participants • All randomized participants	3 Participants n=4 Participants • All randomized participants
Race (NIH/OMB) White	3 Participants n=5 Participants • All randomized participants	3 Participants n=7 Participants • All randomized participants	5 Participants n=5 Participants • All randomized participants	11 Participants n=4 Participants • All randomized participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • All randomized participants	0 Participants n=7 Participants • All randomized participants	0 Participants n=5 Participants • All randomized participants	0 Participants n=4 Participants • All randomized participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All randomized participants	0 Participants n=7 Participants • All randomized participants	0 Participants n=5 Participants • All randomized participants	0 Participants n=4 Participants • All randomized participants

PRIMARY outcome

Timeframe: 28 Days

Population: Insufficient data available to perform analysis due to study termination

The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 90 days

Population: Insufficient data available to perform analysis due to study termination

The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Insufficient data available to perform analysis due to study termination

MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated participants experiencing these events at Day 90 was to be reported by arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 28

Population: Insufficient data available to perform analysis due to study termination

The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 90

Population: Insufficient data available to perform analysis due to study termination

The percentage of participants with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 90

Population: Insufficient data available to perform analysis due to study termination

The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BMS-986141 0.8 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

BMS-986141 4.8 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=3 participants at risk Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141	BMS-986141 0.8 mg n=5 participants at risk BMS-986141 0.8 mg QD for up to 28 days	BMS-986141 4.8 mg n=7 participants at risk BMS-986141 4.8 mg QD for up to 28 days
Nervous system disorders Encephalopathy	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/5 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)

Other adverse events

Other adverse events
Measure	Placebo n=3 participants at risk Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141	BMS-986141 0.8 mg n=5 participants at risk BMS-986141 0.8 mg QD for up to 28 days	BMS-986141 4.8 mg n=7 participants at risk BMS-986141 4.8 mg QD for up to 28 days
Investigations Blood Potassium Increased	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	20.0% 1/5 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/7 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Infections and infestations Tinea Pedis	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/5 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/5 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Reproductive system and breast disorders Vulvovaginal Pruritis	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/5 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Infections and infestations Sinusitis	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/5 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/5 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Renal and urinary disorders Micturation Urgency	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	20.0% 1/5 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/7 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Gastrointestinal disorders Constipation	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	40.0% 2/5 • Number of events 2 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/7 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
General disorders Oedema Peripheral	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	20.0% 1/5 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/7 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	40.0% 2/5 • Number of events 2 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/7 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	20.0% 1/5 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/7 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	20.0% 1/5 • Number of events 1 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)	0.00% 0/7 • From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 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 Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER