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
Primary Purpose
Coronary Artery Disease, Healthy Participants
Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Ticagrelor
BMS-986141
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Thrombosis, Coronary Artery Disease, Healthy Participants, Aspirin, Ticagrelor, Brilinta, BMS-986141
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
Sites / Locations
- Local Institution - 0001Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment Arm 1: Ticagrelor + BMS-986141
Treatment Arm 2: Aspirin + BMS-986141
Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141
Treatment Arm 4: BMS-986141
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in thrombus area in participants receiving post-treatment BMS-986141
Secondary Outcome Measures
Number of participants with Adverse Events (AEs)
Number of participants with clinical laboratory abnormalities
Number of participants with vital sign abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05093790
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
September 8, 2022 (Anticipated)
Study Completion Date
September 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Healthy Participants
Keywords
Thrombosis, Coronary Artery Disease, Healthy Participants, Aspirin, Ticagrelor, Brilinta, BMS-986141
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm 1: Ticagrelor + BMS-986141
Arm Type
Experimental
Arm Title
Treatment Arm 2: Aspirin + BMS-986141
Arm Type
Experimental
Arm Title
Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141
Arm Type
Experimental
Arm Title
Treatment Arm 4: BMS-986141
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilinta
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986141
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetylsalicylic acid (ASA)
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Change from baseline in thrombus area in participants receiving post-treatment BMS-986141
Time Frame
Up to 2 days
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs)
Time Frame
Up to 8 days
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 1 day
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 2 days
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0001
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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
We'll reach out to this number within 24 hrs