A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03766581 Active, not recruiting December 6, 2018 April 5, 2022

study description
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.

Condition or Disease: Acute Ischemic Stroke
Transient Ischemic Attack (TIA)
Intervention/treatment: Drug: Aspirin
Drug: BMS-986177
Other: Placebo
Drug: Clopidogrel
Phase: Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 2366 participants
Allocation : Randomized
Intervention Model : Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Actual Study Start Date: January 2019
Estimated Primary Completion Date: April 2022
Estimated Study Completion Date: April 2022

Arms and interventions
Arm Intervention/treatment
Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
Placebo Comparator: BMS-986177 Placebo
Specified Dose on Specified Days
Other: Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration
outcome measures
Primary Outcome Measures: 1. Composite of new ischemic stroke during the treatment period and new covert brain infarction (FLAIR + DWI) detected by MRI [ Time Frame: Up to 90 days ]
Secondary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: First dose up to 97 days ]
2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: First dose up to 97 days ]
3. Change from Baseline in Heart Rate [ Time Frame: Up to 90 Days ]
4. Change from Baseline in Blood Pressure [ Time Frame: Up to 90 Days ]
5. Change from Baseline in Respiratory Rate [ Time Frame: Up to 90 Days ]
6. Change from Baseline in Body Temperature [ Time Frame: Up to 90 Days ]
7. Incidence of Abnormalities in Physical Examination [ Time Frame: Up to 90 days ]
8. Incidence of Electrocardiogram (ECG) abnormalities [ Time Frame: Up to 90 Days ]
9. Change from baseline in Clinical Laboratory Value of blood [ Time Frame: Up to 90 Days ]
10. Change from baseline in Clinical Laboratory Value of Urine [ Time Frame: Up to 90 Days ]
11. Change from Baseline in Volume of Distribution (Vd) [ Time Frame: Up to 90 days ]
12. Change from baseline in Clinical Laboratory Value of Blood Serum [ Time Frame: Up to 90 Days ]
13. Change from Baseline in Estimated Clearance (CL) [ Time Frame: Up to 90 Days ]
14. Assessment of Stroke Severity by the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Day 21 and Day 90 ]
15. Assessment of Neurological function by the modified Rankin Scale (mRS) [ Time Frame: Day 21 and Day 90 ]
16. Assessment of Cognitive function as by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Day 21 and Day 90 ]
17. Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: Up to 90 days ]
18. Event rate based on BARC, International Society on Thrombosis and Hemostasis (ISTH) and Platelet Inhibition and Patient Outcomes (PLATO)-defined criteria [ Time Frame: Up to 90 days ]
19. Rate of the composite of new ischemic stroke and new covert brain infarction during the treatment period [ Time Frame: Up to 90 days ]
20. Location of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
21. Number of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
22. Volume of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
23. Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction and all-cause death during the treatment period [ Time Frame: Up to 90 days ]
24. Percent change from baseline in aPTT clotting activity during treatment [ Time Frame: Up to 90 Days ]
25. Percent change from baseline in Factor XI clotting activity during treatment [ Time Frame: Up to 90 Days ]

Eligibility Criteria
Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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


Contacts and Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Janssen, LP
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT03766581     
Other Study ID Numbers : CV010-031
First Posted : December 6, 2018
Last Update Posted : April 5, 2022
Last Verified : April 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms :
Ischemic Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Stroke