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

NCT05093790 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CV006-0372020-005209-18
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Healthy Participants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Thrombus Area

  The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication.

  Baseline, Day 1 hour 2, Day 2 hour 24

Secondary Outcomes (4)

• Number of Participants Experiencing Abnormal Vital Signs

  Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2

• Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values

  Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing

• Number of Participants Experiencing Clinical Lab Abnormalities

  From baseline up to 24 hours post dose

• Number of Participants Experiencing Adverse Events (AEs)

  From first dose up to 8 days post last dose

Study Arms (4)

Treatment Arm 1: Ticagrelor + BMS-986141

EXPERIMENTAL

Drug: Ticagrelor; Drug: BMS-986141

Treatment Arm 2: Aspirin + BMS-986141

EXPERIMENTAL

Drug: BMS-986141; Drug: Aspirin

Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141

EXPERIMENTAL

Drug: Ticagrelor; Drug: BMS-986141; Drug: Aspirin

Treatment Arm 4: BMS-986141

EXPERIMENTAL

Drug: BMS-986141

Interventions

Ticagrelor DRUG

Specified dose on specified days

Also known as: Brilinta

Treatment Arm 1: Ticagrelor + BMS-986141; Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141

BMS-986141 DRUG

Specified dose on specified days

Treatment Arm 1: Ticagrelor + BMS-986141; Treatment Arm 2: Aspirin + BMS-986141; Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141; Treatment Arm 4: BMS-986141

Aspirin DRUG

Specified dose on specified days

Also known as: Acetylsalicylic acid (ASA)

Treatment Arm 2: Aspirin + BMS-986141; Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38357820 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Coronary Artery Disease; Thrombosis

Interventions

Ticagrelor; BMS-986141; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 26, 2021
• Study Start: March 25, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-11

Locations

GB (1)