Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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" | PHASE2 | COMPLETED | 16 | — | — | Apr 25, 2016 | Mar 31, 2017 | Dec 14, 2018 | 33 | United States, Japan |
| NCT02341638 | Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects | PHASE1 | COMPLETED | 148 | — | — | Sep 1, 2014 | Sep 1, 2015 | Mar 31, 2017 | 2 | United States |
The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.
The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.
Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG)
| Arm | Type | Description |
|---|---|---|
| BMS-986141 0.8mg | EXPERIMENTAL | BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) |
| BMS-986141 4.8mg | EXPERIMENTAL | BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets) |
| Placebo | PLACEBO_COMPARATOR | Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets) |
| Part A Panel 1: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 2: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 3: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 4: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 5: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 6: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 7: BMS-986141 | EXPERIMENTAL | Single dose by mouth as specified |
| Part A Panel 8: BMS-986141 | EXPERIMENTAL | Single dose by mouth as specified |
| Part B Panel 1: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo by mouth as specified |
| Part B Panel 2: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo by mouth as specified |
| Part B Panel 3: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo by mouth as specified |
| Part C Panel 1: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo by mouth as specified |
| Part C Panel 2: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo by mouth as specified |
| Part C Panel 3: BMS-986141 or Placebo | EXPERIMENTAL | BMS-986141 or Placebo by mouth as specified |
| Part D Panel 1: BMS-986141 and Aspirin | EXPERIMENTAL | BMS-986141 and Aspirin by mouth as specified |
| Part D Panel 1: Placebo matching BMS-986141 and Aspirin | PLACEBO_COMPARATOR | BMS-986141 placebo and Aspirin by mouth as specified |
| Part E Panel 1: BMS-986141 and Itraconazole | EXPERIMENTAL | BMS-986141 and Itraconazole by mouth as specified |
| Name | Type | Description |
|---|---|---|
| BMS-986141 | DRUG | - |
| Aspirin | DRUG | - |
| Placebo | OTHER | - |
| Itraconazole | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male or female, age 18 or older * Must have had a very recent stroke or transient ischemic attack ("mini stroke") that can be confirmed by the study doctor * Able to be assig...