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

Last updated: November 13, 2023
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

2

Condition

Chest Pain

Heart Disease

Vascular Diseases

Treatment

BMS-986141

Ticagrelor

Aspirin

Clinical Study ID

NCT05093790
CV006-037
2020-005209-18
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit: www.BMSStudyConnect.com Inclusion Criteria:

  • Male or female between 18 to 75 years of age, inclusive, and body mass index (weightkg/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 andprocedures required for the experiment and are willing to participate in theexperiment
  • Willing/able to adhere to the visit schedule
  • For treatment arms groups with stable CAD participants (not for healthy volunteerswithout CAD) one or more of: Prior angiographically proven CAD (>50% stenosis ofproximal coronary artery), prior coronary revascularization (PCI or CABG), priormyocardial infarction (MI)

Exclusion

Exclusion Criteria:

  • Participants who meet any of the following criteria will be excluded fromparticipating in the experiment: Allergies or intolerance of aspirin, ticagrelor andBMS-986141, requirement for dual antiplatelet therapy, requirement for anticoagulanttherapy
  • 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 considersshould exclude the participants/patients of that could interfere with theinterpretation to the results
  • Acute illness, including a common cold, within 7 days prior to visit or othersignificant 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 oralcohol 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 4weeks
  • Any condition that, in the opinion of the investigator, would compromise the wellbeingof the blood donor subject or the experiment or prevent the blood donor subject frommeeting or performing experiment requirements Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 58
Treatment Group(s): 3
Primary Treatment: BMS-986141
Phase: 2
Study Start date:
March 25, 2022
Estimated Completion Date:
November 14, 2022

Connect with a study center

  • Local Institution - 0001

    Edinburgh, EH16 4SA
    United Kingdom

    Site Not Available

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