A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2022-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the effectiveness, safety and tolerability of BMS-986141 added on to aspirin or ticagrelor or the combination on thrombus formation in both healthy participants and participants with stable coronary artery disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Healthy Participants

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Thrombosis Coronary Artery Disease Healthy Participants Aspirin Ticagrelor Brilinta BMS-986141

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Arm 1: Ticagrelor + BMS-986141

Group Type EXPERIMENTAL

Ticagrelor

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Brilinta Acetylsalicylic acid (ASA)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female between 18 to 75 years of age, inclusive, and body mass index (weight kg/m2) between 18 and 35 kg/m2 (inclusive), and body weight 50 kg and 120 kg (inclusive)
* Judged to be generally in good health based on medical history, physical examination, ECGs, vital signs and laboratory tests
* Signed an informed consent document indicating they understand the purpose of and procedures required for the experiment and are willing to participate in the experiment
* Willing/able to adhere to the visit schedule
* For treatment arms groups with stable CAD participants (not for healthy volunteers without CAD) one or more of: Prior angiographically proven CAD (\>50% stenosis of proximal coronary artery), prior coronary revascularization (PCI or CABG), prior myocardial infarction (MI)

Exclusion Criteria

* Participants who meet any of the following criteria will be excluded from participating in the experiment: Allergies or intolerance of aspirin, ticagrelor and BMS-986141, requirement for dual antiplatelet therapy, requirement for anticoagulant therapy
* Acute Coronary syndrome or coronary revascularization within 3 months
* Coagulation disorders (including any abnormal bleeding or blood dyscrasias), anemia, renal or hepatic insufficiency or any others illness that the investigator considers should exclude the participants/patients of that could interfere with the interpretation to the results
* Acute illness, including a common cold, within 7 days prior to visit or other significant acute or chronic medical illness
* Major or traumatic surgery within 12 weeks of screening
* History of, a reason to believe that, a blood donor subject has a history of drug or alcohol abuse within the past 5 years or has not abstained from alcohol for at least 24 hours prior to visit
* Positive serum or urine pregnancy test
* Not anatomically suitable for or unwilling to undergo venipunctures
* Participation in a study of an investigational medicinal product within the last 4 weeks
* Any condition that, in the opinion of the investigator, would compromise the wellbeing of the blood donor subject or the experiment or prevent the blood donor subject from meeting or performing experiment requirements

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0001

Edinburgh, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Nash J, Meah MN, Whittington B, Debono S, Raftis J, Miller MR, Sorbie A, Mills NL, Nespoux J, Bruce L, Duffin R, Dhaun N, Brittan M, Chao L, Merali S, Kim M, Wang Z, Zhang Y, Jin S, Wang B, Kozinn M, Newby DE. PAR4 Antagonism in Patients With Coronary Artery Disease Receiving Antiplatelet Therapies. Arterioscler Thromb Vasc Biol. 2024 Apr;44(4):987-996. doi: 10.1161/ATVBAHA.123.320448. Epub 2024 Feb 15.

Reference Type DERIVED

PMID: 38357820 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-005209-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV006-037

Identifier Type: -

Identifier Source: org_study_id

A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Treatment Arm 1: Ticagrelor + BMS-986141

Ticagrelor

BMS-986141

Treatment Arm 2: Aspirin + BMS-986141

BMS-986141

Aspirin

Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141

Ticagrelor

BMS-986141

Aspirin

Treatment Arm 4: BMS-986141

BMS-986141

Interventions

Ticagrelor

BMS-986141

Aspirin

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Bristol-Myers Squibb

Responsible Party

Principal Investigators

Bristol-Myers Squibb

Locations

Local Institution - 0001

Countries

References

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

Related Links

Other Identifiers

2020-005209-18

CV006-037