Phase 2
Completed N=2,366
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Stroke · Transient Ischemic Attack (TIA)
Source: ClinicalTrials.gov NCT03766581 ↗
Enrolled (actual)
2,366
Serious AEs
13.5%
Results posted
Jun 2023
Primary outcomePrimary: Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90 — 16.8; 16.7; 16.6; 15.6 Percentage of participants
Summary
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90 |
16.8; 16.7; 16.6; 15.6; 15.4; 15.3 | — |
| SECONDARY Percent of Participants With Major Bleeding According to BARC Type 3 and 5 |
0.6; 0.6; 0.6; 1.5; 1.6; 1.5 | — |
| SECONDARY Number of Participants With Bleeding Based on BARC Types 1-5 |
41; 26; 16; 28; 25; 22 | — |
| SECONDARY Number of Participants With Bleeding Based on ISTH-Defined Criteria |
4; 2; 2; 5; 6; 5 | — |
| SECONDARY Number of Participants With Bleeding Based on PLATO-Defined Criteria |
2; 1; 1; 4; 3; 2 | — |
| SECONDARY Percent of Participants With Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90 |
16.6; 16.2; 18.5; 14.1; 14.8; 16.4 | — |
| SECONDARY Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death |
6.1; 5.2; 4.7; 4.9; 5.2; 9.4 | — |
| SECONDARY National Institutes of Health Stroke Scale (NIHSS) |
1.6; 1.7; 1.6; 1.6; 1.8; 1.6 | — |
| SECONDARY Modified Rankin Scale (mRS) |
0.5; 0.6; 0.6; 0.5; 0.5; 0.6 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
22.3; 21.6; 22.0; 22.5; 22.4; 22.1 | — |
| SECONDARY Digit Symbol Substitution Test (DSST) |
34.9; 31.2; 32.9; 37.2; 33.7; 31.7 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
399; 190; 186; 192; 193; 211 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Sign Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Physical Examination Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities - Liver |
4; 2; 0; 2; 3; 3 | — |
| SECONDARY Percent Change From Baseline in aPTT Activity |
2.47; 38.72; 58.30; 97.32; 140.76; 193.64 | — |
| SECONDARY Percent Change From Baseline in Factor XI Clotting Activity |
4.48; -8.88; -17.67; -37.20; -61.52; -70.25 | — |
| SECONDARY Pharmacokinetic Parameter - Estimated Clearance (CL) |
8.15; 8.01; 7.54; 7.08; 7.43 | — |
| SECONDARY Pharmacokinetic Parameter - Volume of the Central Compartment (VC) |
34.9; 31.4; 30.9; 28.9; 31.6 | — |
| SECONDARY Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI |
2.3492; 0.8976; 2.9902; 1.2682; 1.4727; 1.2711 | — |
| SECONDARY Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI |
82; 40; 49; 36; 35; 35 | — |
Eligibility Criteria
Inclusion Criteria
- Male and Female ≥40 years of age
- Acute Ischemic Stroke or Transient Ischemic Attack
- Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area
Exclusion Criteria
- Predicted inability to swallow study medication
- Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
- Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03766581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.