Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Healthy Participants
Keywords: Thrombosis
Coronary Artery Disease
Healthy Participants
Aspirin
Ticagrelor
Brilinta
BMS-986141
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Thrombus Area
timeFrame: Baseline, Day 1 hour 2, Day 2 hour 24
Secondary outcomes:
measure: Number of Participants Experiencing Abnormal Vital Signs
timeFrame: Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2
measure: Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
timeFrame: Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing
measure: Number of Participants Experiencing Clinical Lab Abnormalities
timeFrame: From baseline up to 24 hours post dose
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose up to 8 days post last dose
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: