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Coronary Artery DiseasePhase 2NCT05093790

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

A Phase 2 study testing Ticagrelor, BMS-986141 and Aspirin in people with Coronary Artery Disease and Healthy Participants, run by Bristol-Myers Squibb at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease, Healthy Participants
What is being tested?
Ticagrelor, BMS-986141 and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited Kingdom
Study dates
25 Mar 2022to 14 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Local Institution - 0001

    Edinburgh, EH16 4SA

Other trials in United Kingdom

About this study

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

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.

Being tested
Ticagrelor, BMS-986141, Aspirin
Keywords
Thrombosis, Coronary Artery Disease, Healthy Participants, Aspirin, Ticagrelor, Brilinta, BMS-986141
Medical subject headings
Coronary Artery Disease, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called Brilinta

    Specified dose on specified days

  • BMS-986141Drug

    Specified dose on specified days

  • AspirinDrug

    Also called Acetylsalicylic acid (ASA)

    Specified dose on specified days

Study groups in NCT05093790
Study groupRoleWhat they receive
Treatment Arm 1: Ticagrelor + BMS-986141ExperimentalNot described
Receives: Drug: Ticagrelor; Drug: BMS-986141
Treatment Arm 2: Aspirin + BMS-986141ExperimentalNot described
Receives: Drug: BMS-986141; Drug: Aspirin
Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141ExperimentalNot described
Receives: Drug: Ticagrelor; Drug: BMS-986141; Drug: Aspirin
Treatment Arm 4: BMS-986141ExperimentalNot described
Receives: Drug: BMS-986141

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Day 1 hour 2, Day 2 hour 24

Secondary outcomes (4)

  1. 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.

    Measured: Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2

  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.

    Measured: Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing

  3. 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.

    Measured: From baseline up to 24 hours post dose

  4. 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.

    Measured: From first dose up to 8 days post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start25 Mar 2022
  3. Primary completion14 Nov 2022
  4. Study completion14 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093790
Sponsor's protocol ID
CV006-037
Other IDs
2020-005209-18
Status last verified
Nov 2023
First submitted
14 Oct 2021
Last updated
5 Dec 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 38357820

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ticagrelor, BMS-986141 and Aspirin in people with Coronary Artery Disease and Healthy Participants, run by Bristol-Myers Squibb at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Thrombus Area (time frame: Baseline, Day 1 hour 2, Day 2 hour 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093790, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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Clinical Trial NCT05093790 | AzTrials