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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05093790

Collaborator

(none)

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Healthy Participants	Drug: Ticagrelor Drug: BMS-986141 Drug: Aspirin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2a Single Dose Study to Evaluate the Effect of BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Patients With Stable Coronary Artery Disease and Healthy Participants

Actual Study Start Date :

Mar 25, 2022

Anticipated Primary Completion Date :

Sep 8, 2022

Anticipated Study Completion Date :

Sep 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm 1: Ticagrelor + BMS-986141	Drug: Ticagrelor Specified dose on specified days Other Names: Brilinta Drug: BMS-986141 Specified dose on specified days
Experimental: Treatment Arm 2: Aspirin + BMS-986141	Drug: BMS-986141 Specified dose on specified days Drug: Aspirin Specified dose on specified days Other Names: Acetylsalicylic acid (ASA)
Experimental: Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141	Drug: Ticagrelor Specified dose on specified days Other Names: Brilinta Drug: BMS-986141 Specified dose on specified days Drug: Aspirin Specified dose on specified days Other Names: Acetylsalicylic acid (ASA)
Experimental: Treatment Arm 4: BMS-986141	Drug: BMS-986141 Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Change from baseline in thrombus area in participants receiving post-treatment BMS-986141 [Up to 2 days]

Secondary Outcome Measures

Number of participants with Adverse Events (AEs) [Up to 8 days]
Number of participants with clinical laboratory abnormalities [Up to 1 day]
Number of participants with vital sign abnormalities [Up to 2 days]
Number of participants with electrocardiogram (ECG) abnormalities [Up to 1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

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