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
NCT05093790, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2023-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05093790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05093790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT05093790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Coronary Artery Disease, Healthy Participants
- Interventions
- Ticagrelor, BMS-986141, Aspirin
- First posted
- 2021-10-26
- Last updated
- 2023-12-05
- Other registries' IDs
- eudract:2020-005209-18
- Results first posted
- 2023-12-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Thrombus Area | 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 | Number of Participants Experiencing Abnormal Vital Signs | 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. |
| Secondary | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | 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. |
| Secondary | Number of Participants Experiencing Clinical Lab Abnormalities | 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. |
| Secondary | Number of Participants Experiencing Adverse Events (AEs) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Thrombus Area | Baseline, Day 1 hour 2, Day 2 hour 24 | Biomarker population-all treated participants who had any available biomarker data | Percent Change | MEAN |
| SECONDARY | Number of Participants Experiencing Abnormal Vital Signs | Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2 | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values | Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Clinical Lab Abnormalities | From baseline up to 24 hours post dose | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Adverse Events (AEs) | From first dose up to 8 days post last dose | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group280
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Thrombus Area | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | On-treatment Day 1, Hour 2, Low Shear | 10.0 | Standard Deviation 260.3 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | On-treatment Day 1, Hour 2, Low Shear | 538.6 | Standard Deviation 1803.3 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | On-treatment Day 1, Hour 2, Low Shear | 104.2 | Standard Deviation 383.5 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 4: Heathy Participants | On-treatment Day 1, Hour 2, Low Shear | -14.9 | Standard Deviation 50.2 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | On-treatment Day 1, Hour 2, High Shear | -23.0 | Standard Deviation 24.1 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | On-treatment Day 1, Hour 2, High Shear | -18.4 | Standard Deviation 27.5 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | On-treatment Day 1, Hour 2, High Shear | -24.2 | Standard Deviation 17.2 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 4: Heathy Participants | On-treatment Day 1, Hour 2, High Shear | -27.7 | Standard Deviation 24.4 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | Post-treatment Day 2, Hour 24, Low Shear | 20.7 | Standard Deviation 134.6 | Percent Change |
| Percent Change From Baseline in Thrombus Area | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | Post-treatment Day 2, Hour 24, Low Shear | 579.6 | Standard Deviation 2125.4 | Percent Change |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 16 | |
| Overall Study | STARTED | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 15 | |
| Overall Study | STARTED | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 16 | |
| Overall Study | STARTED | Arm 4: Heathy Participants | 11 | |
| Overall Study | COMPLETED | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 15 | |
| Overall Study | COMPLETED | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 15 | |
| Overall Study | COMPLETED | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 15 | |
| Overall Study | COMPLETED | Arm 4: Heathy Participants | 11 | |
| Overall Study | NOT COMPLETED | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 1 | |
| Overall Study | NOT COMPLETED | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 1 | 16 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 | 15 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 1 | 16 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Arm 4: Heathy Participants | 0 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 1 | 16 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 1 | 16 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 4: Heathy Participants | 0 | 11 | |
| other | COVID-19 | Infections and infestations | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 2 | 16 | |
| other | COVID-19 | Infections and infestations | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 | 15 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 0 | 16 |
| Total, all-cause mortality | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 | 15 |
| Total, all-cause mortality | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 0 | 16 |
| Total, all-cause mortality | Arm 4: Heathy Participants | 0 | 11 |
| Total, other adverse events | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 6 | 16 |
| Total, other adverse events | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 | 15 |
| Total, other adverse events | Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 4 | 16 |
| Total, other adverse events | Arm 4: Heathy Participants | 1 | 11 |
| Total, serious adverse events | Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 0 | 16 |
| Total, serious adverse events | Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38357820 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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