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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005209-18 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1: Ticagrelor + BMS-986141 | Experimental |
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| Treatment Arm 2: Aspirin + BMS-986141 | Experimental |
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| Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141 | Experimental |
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| Treatment Arm 4: BMS-986141 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Edinburgh | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38357820 | Derived | Nash J, Meah MN, Whittington B, Debono S, Raftis J, Miller MR, Sorbie A, Mills NL, Nespoux J, Bruce L, Duffin R, Dhaun N, Brittan M, Chao L, Merali S, Kim M, Wang Z, Zhang Y, Jin S, Wang B, Kozinn M, Newby DE. PAR4 Antagonism in Patients With Coronary Artery Disease Receiving Antiplatelet Therapies. Arterioscler Thromb Vasc Biol. 2024 Apr;44(4):987-996. doi: 10.1161/ATVBAHA.123.320448. Epub 2024 Feb 15. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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58 participants received study treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2021 |
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| BMS-986141 | Drug | Specified dose on specified days |
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| Aspirin | Drug | Specified dose on specified days |
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| Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2 |
| 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 |
| 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 |
| 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 |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| Arm 2: 75 mg Aspirin + 4 mg BMS-986141 |
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2. |
| FG002 | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2. |
| FG003 | Arm 4: Heathy Participants | Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2. |
| BG001 | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2. |
| BG002 | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2. |
| BG003 | Arm 4: Heathy Participants | Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Biomarker population-all treated participants who had any available biomarker data | Posted | Mean | Standard Deviation | Percent Change | Baseline, Day 1 hour 2, Day 2 hour 24 |
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| 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. | All treated participants | Posted | Count of Participants | Participants | 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. | All treated participants | Posted | Count of Participants | Participants | 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. | All treated participants | Posted | Count of Participants | Participants | 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. | All treated participants | Posted | Count of Participants | Participants | From first dose up to 8 days post last dose |
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Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2. | 0 | 16 | 0 | 16 | 6 | 16 |
| EG001 | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2. | 0 | 16 | 0 | 16 | 4 | 16 |
| EG003 | Arm 4: Heathy Participants | Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1. | 0 | 11 | 0 | 11 | 1 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Nov 13, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| C000729678 | BMS-986141 |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| On-treatment Day 1, Hour 2, High Shear |
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| Post-treatment Day 2, Hour 24, Low Shear |
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| Post-treatment Day 2, Hour 24, High Shear |
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Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2. |
| OG002 | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2. |
| OG003 | Arm 4: Heathy Participants | Heathy Participants |
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Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2. |
| OG003 | Arm 4: Heathy Participants | Heathy Participants |
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| OG003 | Arm 4: Heathy Participants | Heathy Participants |
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| OG002 |
| Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 |
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2. |
| OG003 | Arm 4: Heathy Participants | Heathy Participants |
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