Clinical trial NCT03766581: A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Transient Ischemic Attack (TIA)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Janssen, LP
First posted: 2018-12-06
Enrollment: 2366
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: From randomization to up to 90 days after randomization
Secondary outcomes:
measure: Percent of Participants With Major Bleeding According to BARC Type 3 and 5
timeFrame: From first dose to up to 107 days after first dose
measure: Number of Participants With Bleeding Based on BARC Types 1-5
timeFrame: From first dose to up to 107 days after first dose
measure: Number of Participants With Bleeding Based on ISTH-Defined Criteria
timeFrame: From first dose to up to 107 days after first dose
measure: Number of Participants With Bleeding Based on PLATO-Defined Criteria
timeFrame: From first dose to up to 107 days after first dose
measure: 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
timeFrame: From randomization to up to 90 days after randomization
measure: Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death
timeFrame: From randomization to up to 90 days after randomization
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At baseline, on Days 21 and 90, and at the time of a new stroke event
measure: Modified Rankin Scale (mRS)
timeFrame: At baseline, on Days 21 and 90, and at the time of a new stroke event
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At baseline, on Days 21 and 90, and at the time of a new stroke event
measure: Digit Symbol Substitution Test (DSST)
timeFrame: At baseline, on Days 21 and 90, and at the time of a new stroke event
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 2 days after last dose of study therapy (up to approximately 107 days)
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: From first dose to up to 90 days after first dose
measure: Number of Participants With Clinically Significant Physical Examination Abnormalities
timeFrame: From first dose to up to 90 days after first dose
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: From first dose to up to 90 days after first dose
measure: Number of Participants With Clinically Significant Laboratory Abnormalities - Liver
timeFrame: From first dose to up to approximately 38 months
measure: Percent Change From Baseline in aPTT Activity
timeFrame: Baseline and day 90
measure: Percent Change From Baseline in Factor XI Clotting Activity
timeFrame: Baseline and day 90
measure: Pharmacokinetic Parameter - Estimated Clearance (CL)
timeFrame: From first dose to up to 90 days after first dose
measure: Pharmacokinetic Parameter - Volume of the Central Compartment (VC)
timeFrame: From first dose to up to 90 days after first dose
measure: Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
timeFrame: At day 90
measure: Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
timeFrame: At day 90
Other outcomes:
measure: Percent of Participants With Ischemic Stroke Events
timeFrame: From randomization to up to 90 days after randomization
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0029
state: Alabama
city: Glendale
country: United States
facility: Local Institution - 0007
state: California
city: Long Beach
country: United States
facility: Local Institution - 0006
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
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state: California
city: Sacramento
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city: Isesaki-shi
country: Japan
facility: Local Institution - 0211
state: Gunma
city: Aki-gun
country: Japan
facility: Local Institution - 0337
state: Hiroshima
city: Higashihiroshima-shi
country: Japan
facility: Local Institution - 0240
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Local Institution - 0328
state: Hiroshima
city: Kobe-City
country: Japan
facility: Local Institution - 0226
state: Hyogo
city: Kanazawa
country: Japan
facility: Local Institution - 0323
state: Ishikawa
city: Komatsu
country: Japan
facility: Local Institution - 0446
state: Ishikawa
city: Kagoshima-shi
country: Japan
facility: Local Institution - 0299
state: Kagoshima
city: Kawasaki-city
country: Japan
facility: Local Institution - 0228
state: Kanagawa
city: Kawasaki
country: Japan
facility: Local Institution - 0310
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Local Institution - 0296
state: Miyagi
city: Sendai
country: Japan
facility: Local Institution - 0278
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Local Institution - 0261
state: Nagasaki
city: Izumisano-shi
country: Japan
facility: Local Institution - 0272
state: Osaka
city: Kishiwada
country: Japan
facility: Local Institution
state: Osaka
city: Matsubara
country: Japan
facility: Local Institution - 0279
state: Osaka
city: Sakai-shi
country: Japan
facility: Local Institution - 0322
state: Osaka
city: Suita-shi
country: Japan
facility: Local Institution - 0244
state: Osaka
city: Suita
country: Japan
facility: Local Institution - 0251
state: Osaka
city: Hidaka
country: Japan
facility: Local Institution - 0263
state: Saitama
city: Shimotsuke-shi
country: Japan
facility: Local Institution - 0334
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0232
state: Tokyo
city: Hachioji
country: Japan
facility: Local Institution - 0343
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution - 0255
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0338
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0342
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Local Institution - 0295
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Local Institution - 0298
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0316
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Local Institution - 0318
state: Tokyo
city: Shimonoseki-Shi
country: Japan
facility: Local Institution - 0319
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Local Institution - 0271
city: Fukuoka
country: Japan
facility: Local Institution - 0243
city: Kyoto
country: Japan
facility: Local Institution - 0312
city: Osaka
country: Japan
facility: Local Institution - 0327
city: Osaka
country: Japan
facility: Local Institution - 0239
city: Osaka
country: Japan
facility: Local Institution - 0313
city: Saga
country: Japan
facility: Local Institution - 0301
city: Goyang-si
country: Korea, Republic of
facility: Local Institution - 0094
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0088
state: Seoul Teugbyeolsi
city: Anyang
country: Korea, Republic of
facility: Local Institution - 0081
city: Busan
country: Korea, Republic of
facility: Local Institution - 0109
city: Busan
country: Korea, Republic of
facility: Local Institution - 0166
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0179
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0102
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Gwangju
country: Korea, Republic of
facility: Local Institution - 0105
city: Incheon
country: Korea, Republic of
facility: Local Institution - 0101
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0153
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0087
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0185
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0071
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0080
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0120
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0145
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0152
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0112
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0091
city: Ciudad de Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0398
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0396
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0404
state: Nuevo LEON
city: Culiacan
country: Mexico
facility: Local Institution - 0394
state: Sinaloa
city: Durango
country: Mexico
facility: Local Institution - 0366
city: Bergen
country: Norway
facility: Local Institution - 0368
city: Grålum
country: Norway
facility: Local Institution - 0383
city: Kristiansand
country: Norway
facility: Local Institution
city: Lørenskog
country: Norway
facility: Local Institution - 0130
city: Oslo
country: Norway
facility: Local Institution - 0408
city: Stavanger
country: Norway
facility: Local Institution - 0330
city: Warszawa
country: Poland
facility: Local Institution - 0265
state: Mazowieckie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0350
city: Chelm
country: Poland
facility: Local Institution - 0216
city: Gdansk
country: Poland
facility: Local Institution - 0206
city: Grodzisk Mazowieciki
country: Poland
facility: Local Institution - 0181
city: Katowice
country: Poland
facility: Local Institution - 0253
city: Konskie
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution - 0197
city: Olsztyn
country: Poland
facility: Local Institution - 0198
city: Sandomierz
country: Poland
facility: Local Institution - 0215
city: Skarzysko-Kamienna
country: Poland
facility: Local Institution - 0183
city: Walcz
country: Poland
facility: Local Institution - 0225
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution - 0214
city: Wejherowo
country: Poland
facility: Local Institution - 0212
city: Barnaul
country: Russian Federation
facility: Local Institution - 0277
city: Kemerovo
country: Russian Federation
facility: Local Institution - 0260
city: Moscow
country: Russian Federation
facility: Local Institution - 0306
city: Moscow
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 0268
city: Smolensk
country: Russian Federation
facility: Local Institution - 0202
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0356
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Sabadell
country: Spain
facility: Local Institution - 0159
state: Barcelona
city: Sant Joan Despi
country: Spain
facility: Local Institution - 0163
state: Barcelona
city: León
country: Spain
facility: Local Institution - 0372
state: Castilla Y León
city: A Coruna
country: Spain
facility: Local Institution - 0141
city: Albacete
country: Spain
facility: Local Institution - 0026
city: Badalona
country: Spain
facility: Local Institution - 0052
city: Barcelona
country: Spain
facility: Local Institution - 0012
city: Barcelona
country: Spain
facility: Local Institution - 0010
city: Barcelona
country: Spain
facility: Local Institution - 0027
city: Córdoba
country: Spain
facility: Local Institution - 0385
city: Girona
country: Spain
facility: Local Institution - 0426
city: L'Hospitalet de Llobregat
country: Spain
facility: Local Institution - 0176
city: Lleida
country: Spain
facility: Local Institution - 0249
city: Madrid
country: Spain
facility: Local Institution - 0238
city: Madrid
country: Spain
facility: Local Institution - 0025
city: Madrid
country: Spain
facility: Local Institution - 0413
city: Madrid
country: Spain
facility: Local Institution - 0384
city: San Sebastian
country: Spain
facility: Local Institution - 0400
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0425
city: Sevilla
country: Spain
facility: Local Institution - 0158
city: Sevilla
country: Spain
facility: Local Institution - 0177
city: Tarragona
country: Spain
facility: Local Institution - 0164
city: Terrassa
country: Spain
facility: Local Institution - 0150
city: Valencia
country: Spain
facility: Local Institution - 0147
city: Valladolid
country: Spain
facility: Local Institution - 0014
city: Vigo
country: Spain
facility: Local Institution - 0418
city: Malmö
country: Sweden
facility: Local Institution - 0128
state: Skane Lan
city: Göteborg
country: Sweden
facility: Local Institution - 0171
city: Hassleholm
country: Sweden
facility: Local Institution - 0191
city: Umea
country: Sweden
facility: Local Institution - 0224
city: Uppsala
country: Sweden
facility: Local Institution - 0132
city: Basel
country: Switzerland
facility: Local Institution - 0118
state: Basel-Stadt (de)
city: Bern
country: Switzerland
facility: Local Institution - 0115
state: Bern (de)
city: Aarau
country: Switzerland
facility: Local Institution - 0162
city: Geneve
country: Switzerland
facility: Local Institution - 0203
city: Lausanne
country: Switzerland
facility: Local Institution - 0201
city: Zurich
country: Switzerland
facility: Local Institution
city: Canterbury
country: United Kingdom
facility: Local Institution - 0222
state: Kent
city: Aberdeen
country: United Kingdom
facility: Local Institution - 0140
city: Ashford
country: United Kingdom
facility: Local Institution
city: Bath
country: United Kingdom
facility: Local Institution - 0157
city: Chester
country: United Kingdom
facility: Local Institution - 0089
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0221
city: Glasgow
country: United Kingdom
facility: Local Institution - 0096
city: Lancashire
country: United Kingdom
facility: Local Institution - 0361
city: London
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Luton
country: United Kingdom
facility: Local Institution - 0303
city: Nottingham
country: United Kingdom
facility: Local Institution
city: Salford
country: United Kingdom
facility: Local Institution - 0431
city: Sheffield
country: United Kingdom
facility: Local Institution - 0414
city: Staffordshire
country: United Kingdom
facility: Local Institution - 0307
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: