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NCT02671461
Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
Phase 2 trial testing BMS-986141 in Thrombosis in 16 participants. Completed in 31 March 2017.
31 March 2017
Quick facts
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 25 April 2016 |
| Primary completion | 31 March 2017 |
| Estimated completion | 31 March 2017 |
| Sites | 33 locations across Japan, United States |
Drugs / interventions tested
- BMS-986141 — full drug profile →
- Aspirin — full drug profile →
- Placebo
Conditions studied
- Thrombosis — all drugs for Thrombosis →
Sponsor
Bristol-Myers Squibb — full company profile →
Who can join
18 and older, any sex, with Thrombosis. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (1 terms)
| Reaction | System | Placebo | BMS-986141 0.8 mg | BMS-986141 4.8 mg |
|---|---|---|---|---|
| Encephalopathy | Nervous system disorders | — | — | — |
Other adverse events (12 terms — click to expand)
| Reaction | System | Placebo | BMS-986141 0.8 mg | BMS-986141 4.8 mg |
|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | — | — | — |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | — | — | — |
| Blood Potassium Increased | Investigations | — | — | — |
| Tinea Pedis | Infections and infestations | — | — | — |
| Vaginal Discharge | Reproductive system and breast disorders | — | — | — |
| Vulvovaginal Pruritis | Reproductive system and breast disorders | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Viral Upper Respiratory Tract Infection | Infections and infestations | — | — | — |
| Micturation Urgency | Renal and urinary disorders | — | — | — |
| Oedema Peripheral | General disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
Most-reported serious reactions: Encephalopathy.
Data from ClinicalTrials.gov NCT02671461 adverse events section.
Sponsor's own description
The purpose of this study is to determine whether BMS-986141 is effective in reducing the recurrence of stroke in people who recently had a stroke, or a transient ischemic attack (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as aspirin or ASA) to treat the stroke or TIA.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Protease-activated receptors (PARs): mechanisms of action and potential therapeutic modulators in PAR-driven inflammatory diseases.
Heuberger DM, Schuepbach RA. · · 2019 · cited 274× · PMID 30976204 · DOI 10.1186/s12959-019-0194-8 -
Platelets as Mediators of Neuroinflammation and Thrombosis.
Rawish E, Nording H, Münte T, Langer HF. · · 2020 · cited 101× · PMID 33123127 · DOI 10.3389/fimmu.2020.548631 -
Platelets as Modulators of Cerebral Ischemia/Reperfusion Injury.
Stegner D, Klaus V, Nieswandt B. · · 2019 · cited 76× · PMID 31736950 · DOI 10.3389/fimmu.2019.02505 -
Novel Antiplatelet Therapies for Atherothrombotic Diseases.
Majithia A, Bhatt DL. · · 2019 · cited 53× · PMID 30760019 · DOI 10.1161/atvbaha.118.310955 -
The domino effect triggered by the tethered ligand of the protease activated receptors.
Han X, Nieman MT. · · 2020 · cited 34× · PMID 32853981 · DOI 10.1016/j.thromres.2020.08.004 -
A function-blocking PAR4 antibody is markedly antithrombotic in the face of a hyperreactive PAR4 variant.
French SL, Thalmann C, Bray PF, Macdonald LE, et al · · 2018 · cited 24× · PMID 29884748 · DOI 10.1182/bloodadvances.2017015552 -
PAR4 (Protease-Activated Receptor 4): PARticularly Important 4 Antiplatelet Therapy.
Han X, Nieman MT. · · 2018 · cited 24× · PMID 29367229 · DOI 10.1161/atvbaha.117.310550 -
Using PAR4 Inhibition as an Anti-Thrombotic Approach: Why, How, and When?
Li S, Tarlac V, Hamilton JR. · · 2019 · cited 19× · PMID 31717963 · DOI 10.3390/ijms20225629
Verify or expand the search:
- PubMed search for NCT02671461
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of BMS-986141
Trials testing the same drug.
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- NCT02985632 — A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Parti · Phase 1 · withdrawn
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- NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02671461 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
- Last refreshed: 14 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02671461.
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