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Completed

NCT Number: NCT05093790

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Embolism and Thrombosis Healthy Participants Heart Diseases Myocardial Ischemia Thrombosis Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0001

Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Ticagrelor

Drug

Specified dose on specified days

Other names: Brilinta

BMS-986141

Drug

Specified dose on specified days

Aspirin

Drug

Specified dose on specified days

Other names: Acetylsalicylic acid (ASA)

Primary outcomes

  1. Percent Change From Baseline in Thrombus Area

    Time frame: Baseline, Day 1 hour 2, Day 2 hour 24

    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.

Secondary outcomes

  1. Number of Participants Experiencing Abnormal Vital Signs

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

    The number of participants with abnormal vital sign values. The criteria used for classifying vital sign results as markedly abnormal is listed below. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. For Treatment Arms 1, 2, and 3, a baseline chamber run was performed approximately 2 hours after background therapy (ticagrelor, aspirin, or ticagrelor + aspirin) and prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. For Treatment Arm 4, a baseline chamber run was performed prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. Participants received background therapy before the final chamber run, and the final chamber run was performed on Day 2, approximately 24 hours after BMS-986141 dosing.

  2. Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values

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

    The number of participants with abnormal electrocardiogram values. The criteria used for classifying electrocardiogram results as markedly abnormal is listed below. The 2-hour and 24-hour ECGs should are performed prior to the Badimon Chamber run. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication.

  3. Number of Participants Experiencing Clinical Lab Abnormalities

    Time frame: From baseline up to 24 hours post dose

    The number of participants with abnormal clinical laboratory results. The criteria used for classifying laboratory test results as markedly abnormal is listed below.

  4. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: From first dose up to 8 days post last dose

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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