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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093790
• Other study ID #: CV006-037
• Secondary ID: 2020-005209-18
• Status: Completed
• Phase: Phase 2
• Start date: March 25, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Healthy Participants
• Myocardial Ischemia
• Thrombosis

Intervention

Drug:
• Ticagrelor
Specified dose on specified days
• BMS-986141
Specified dose on specified days
• Aspirin
Specified dose on specified days

Locations

Country	Name	City	State
United Kingdom	Local Institution - 0001	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Experiencing Abnormal Vital Signs	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.	Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2
Secondary	Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values	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.	Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing
Secondary	Number of Participants Experiencing Clinical Lab Abnormalities	The number of participants with abnormal clinical laboratory results. The criteria used for classifying laboratory test results as markedly abnormal is listed below.	From baseline up to 24 hours post dose
Secondary	Number of Participants Experiencing Adverse Events (AEs)	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.	From first dose up to 8 days post last dose

External Links

•   BMS Clinical Trial Information
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•   FDA Safety Alerts and Recalls