NCT03766581|CompletedPhase 2ResultsDMCFDA Drug

A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel

AXIOMATIC-SSP

A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

Bristol-Myers Squibb ClinicalTrials.gov

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1 other identifier

CV010-031

Study Type

interventional

Target

2,366

Locations

28 countries

Sites

416

Timeline

RegisteredDec 2018

StartedJan 2019

CompletionMar 2022

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

2,366

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2019

Typical duration for phase_2

Geographic Reach

28 countries

416 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

November 13, 2018

Completed

23 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

January 27, 2019

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

June 12, 2023

Completed

Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

3.2 years

First QC Date

November 13, 2018

Results QC Date

March 31, 2023

Last Update Submit

June 8, 2023

Conditions

Acute Ischemic Stroke Transient Ischemic Attack (TIA)

Outcome Measures

Primary Outcomes (1)

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
Model based assessment estimate for composite event is a customized statistical analysis called MCP-MOD (Multiple Comparison Procedures, MODel) estimation, which is used to check for dose-response relationship. 95% confidence interval (CI) for composite event based on bootstrap (10000 samples).
From randomization to up to 90 days after randomization

Secondary Outcomes (21)

Percent of Participants With Major Bleeding According to BARC Type 3 and 5
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on BARC Types 1-5
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on ISTH-Defined Criteria
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on PLATO-Defined Criteria
From first dose to up to 107 days after first dose
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
From randomization to up to 90 days after randomization
+16 more secondary outcomes

Other Outcomes (1)

Percent of Participants With Ischemic Stroke Events
From randomization to up to 90 days after randomization