AzTrials
AzTrials

Acute Ischemic StrokePhase 2AXIOMATIC-SSPNCT03766581

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

A Phase 2 study testing BMS-986177, Clopidogrel and Aspirin in people with Acute Ischemic Stroke and Transient Ischemic Attack (TIA), run by Bristol-Myers Squibb at 424 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
BMS-986177, Clopidogrel and Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,366 participants
Where
424 sitesin 29 countries
Study dates
27 Jan 2019to 31 Mar 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

424 sites in 29 countries.

424 sites in 29 countries

United States66 sites

  • Local Institution - 0302

    Abington, Pennsylvania, 19001

  • Local Institution

    Allentown, Pennsylvania, 18103-6381

  • Local Institution - 0015

    Augusta, Georgia, 30912

  • Local Institution - 0008

    Austin, Texas, 78712

  • Local Institution - 0420

    Baltimore, Maryland, 21215

  • Local Institution - 0029

    Birmingham, Alabama, 35233

  • Local Institution

    Boston, Massachusetts, 02118

  • Local Institution - 0236

    Boston, Massachusetts, 02215

  • Local Institution - 0354

    Brooklyn, New York, 11203

  • Local Institution

    Buffalo, New York, 14202

  • Duke University Medical Center

    Butner, North Carolina, 27509-1626

  • Local Institution - 0276

    Camden, New Jersey, 08103

  • Local Institution

    Camp Hill, Pennsylvania, 17011

  • Local Institution - 0043

    Chapel Hill, North Carolina, 27599

  • Local Institution - 0293

    Chicago, Illinois, 60612

  • University of Illinois Hospital & Health Sciences System

    Chicago, Illinois, 60612

  • Local Institution - 0003

    Cleveland, Ohio, 44106

  • Local Institution - 0050

    Cleveland, Ohio, 44195

  • Local Institution - 0041

    Columbia, South Carolina, 29203

  • Local Institution - 0419

    Columbus, Ohio, 43210

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75321

  • Local Institution

    Dallas, Texas, 75390-88520

  • Local Institution

    Detroit, Michigan, 48201

  • Local Institution - 0434

    Detroit, Michigan, 48202

  • Local Institution

    Detroit, Michigan, 48235

  • University Medical center of El Paso

    El Paso, Texas, 79905

  • Local Institution - 0430

    Elk Grove Village, Illinois, 60007

  • Local Institution - 0018

    Erie, Pennsylvania, 16550-0001

  • Local Institution - 0375

    Farmington Hills, Michigan, 48334

  • Local Institution - 0075

    Gainesville, Florida, 32610

  • Local Institution - 0007

    Glendale, California, 91206

  • Advanced Neurology Specialists PLLC

    Great Falls, Montana, 59405

  • Local Institution - 0016

    Greensboro, North Carolina, 27405

  • Local Institution - 0428

    Honolulu, Hawaii, 96813

  • Local Institution - 0040

    Houston, Texas, 77030

  • Local Institution - 0093

    Houston, Texas, 77030

  • Local Institution

    Kansas City, Missouri, 64111

  • Local Institution - 0006

    Long Beach, California, 90806

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Local Institution - 0231

    Los Angeles, California, 90095

  • Local Institution - 0346

    Louisville, Kentucky, 40202

  • Local Institution

    Milwaukee, Wisconsin, 53226

  • Local Institution

    Minneapolis, Minnesota, 55415

  • Local Institution - 0009

    Nashville, Tennessee, 37232-6307

  • Local Institution - 0039

    New Brunswick, New Jersey, 08901

  • Local Institution - 0047

    New Orleans, Louisiana, 70121

  • Local Institution

    New York, New York, 10016

  • Local Institution - 0125

    New York, New York, 10032

  • Local Institution - 0340

    Newark, Delaware, 19713

  • Local Institution - 0218

    Oklahoma City, Oklahoma, 73112

  • Local Institution - 0020

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Local Institution - 0022

    Portland, Oregon, 97239-3011

  • Local Institution

    Richmond, Virginia, 23298

  • Local Institution - 0382

    Rockford, Illinois, 61114

  • Local Institution - 0376

    Sacramento, California, 95817

  • Local Institution - 0013

    Sarasota, Florida, 34239

  • Local Institution

    St Louis, Missouri, 63104

  • Local Institution - 0294

    St Louis, Missouri, 63110

  • Local Institution - 0352

    St Louis, Missouri, 63110

  • Local Institution - 0004

    Stanford, California, 94305

  • Local Institution - 0024

    Tampa, Florida, 33606

  • Local Institution - 0187

    Temple, Texas, 76508

  • Local Institution - 0042

    Torrance, California, 90502

  • Local Institution

    Winston-Salem, North Carolina, 27157

  • Local Institution - 0019

    York, Pennsylvania, 17403

Other trials in United States

Japan53 sites

  • Local Institution - 0257

    Aizuwakamatsu-shi, Fukushima, 9658585

  • Local Institution - 0337

    Aki-gun, Hiroshima, 735-8585

  • Local Institution - 0232

    Bunkyo-ku, Tokyo, 113-8603

  • Local Institution - 0320

    Chikushino-shi, Fukuoka, 818-8516

  • Local Institution - 0271

    Fukuoka, 810-0001

  • Local Institution - 0243

    Fukuoka, 810-8563

  • Local Institution - 0343

    Hachiōji, Tokyo, 192-0032

  • Local Institution - 0263

    Hidaka, Saitama, 858+6

  • Local Institution - 0240

    Higashihiroshima-shi, Hiroshima, 739-0041

  • Local Institution - 0328

    Hiroshima, Hiroshima, 731-0293

  • Local Institution - 0211

    Isesaki-shi, Gunma, 372-0006

  • Local Institution - 0272

    Izumisano, Osaka, 5988577

  • Local Institution - 0299

    Kagoshima, Kagoshima-ken, 890-8760

  • Local Institution - 0323

    Kanazawa, Ishikawa-ken, 920-8650

  • Local Institution - 0259

    Kasuga-shi, Fukuoka, 816-0864

  • Local Institution - 0335

    Kasugai, Aichi-ken, 487-0016

  • Local Institution - 0310

    Kawasaki, Kanagawa, 211-0063

  • Local Institution - 0228

    Kawasaki, Kanagawa, 216-8511

  • Local Institution

    Kishiwada, Osaka, 596-8522

  • Local Institution - 0311

    Kitakyushu, Fukuoka, 800-0296

  • Local Institution - 0229

    Kitakyushu-shi, Fukuoka, 802-8555

  • Local Institution - 0270

    Kitakyushu-shi, Fukuoka, 8058508

  • Local Institution - 0226

    Kobe, Hyōgo, 650-0047

  • Local Institution - 0230

    Koga-shi, Fukuoka, 811-3113

  • Local Institution - 0446

    Komatsu, Ishikawa-ken, 923-8560

  • Local Institution - 0324

    Kurume, Fukuoka, 830-8577

  • Local Institution - 0312

    Kyoto, 6008558

  • Local Institution - 0279

    Matsubara, Osaka, 580-0032

  • Local Institution - 0255

    Meguro-ku, Tokyo, 152-8902

  • Local Institution - 0338

    Minato-ku, Tokyo, 1058471

  • Local Institution - 0342

    Minato-ku, Tokyo, 108-0073

  • Local Institution - 0295

    Mitaka-shi, Tokyo, 181-8611

  • Local Institution - 0261

    Nagasaki, Nagasaki, 8528501

  • Local Institution - 0274

    Nagoya, Aichi-ken, 4600001

  • Local Institution - 0327

    Osaka, 533-0024

  • Local Institution - 0239

    Osaka, 540-0006

  • Local Institution - 0313

    Osaka, 558-8558

  • Local Institution - 0301

    Saga, 849-8501

  • Local Institution - 0322

    Sakai-shi, Osaka, 590-0064

  • Local Institution - 0336

    Sakura-shi, Chiba, 285-8741

  • Local Institution - 0296

    Sendai, Miyagi, 982-8523

  • Local Institution - 0278

    Sendai, Miyagi, 9838520

  • Local Institution - 0319

    Shimonoseki-Shi, Yamaguchi, 752-8510

  • Local Institution - 0334

    Shimotsuke-shi, Tochigi, 3290498

  • Local Institution - 0298

    Shinagawa-ku, Tokyo, 141-8625

  • Local Institution - 0316

    Shinjuku-ku, Tokyo, 160-8582

  • Local Institution - 0251

    Suita, Osaka, 5648565

  • Local Institution - 0244

    Suita-shi, Osaka, 565-0871

  • Local Institution - 0318

    Tachikawa-shi, Tokyo, 1900014

  • Local Institution - 0309

    Takayama-shi, Gifu, 506-8550

  • Local Institution - 0331

    Toyoake Shi, Aichi-ken, 4701192

  • Local Institution - 0325

    Toyohashi, Aichi-ken, 440-8510

  • Local Institution - 0317

    Toyota-shi, Aichi-ken, 471-8513

Other trials in Japan

Germany29 sites

  • Local Institution - 0011

    Altenburg, 04600

  • Local Institution - 0032

    Berlin, 12203

  • Local Institution

    Berlin, 12351

  • Local Institution

    Bielefeld, 33617

  • Local Institution - 0250

    Bonn, 53127

  • Local Institution - 0380

    Bremen, 28755

  • Local Institution - 0144

    Dresden, 01307

  • Local Institution - 0097

    Erlangen, 91054

  • Local Institution - 0053

    Essen, 45131

  • Local Institution - 0285

    Frankfurt am Main, Hesse, 65929

  • Local Institution - 0291

    Frankfurt am Main, 60528

  • Local Institution - 0254

    Giessen, 35392

  • Local Institution - 0056

    Hamburg, 20246

  • Local Institution - 0044

    Hamburg, 22043

  • Local Institution - 0034

    Hamburg, 22763

  • Local Institution

    Hanover, D30625

  • Local Institution - 0055

    Heidelberg, 69120

  • Local Institution - 0090

    Leipzig, Saxony, 04103

  • Local Institution - 0258

    Lübeck, Schleswig-Holstein, 23538

  • Local Institution

    Magdeburg, 39120

  • Local Institution - 0036

    Minden, 32429

  • Local Institution - 0256

    Münster, 48149

  • Local Institution - 0378

    Osnabrück, 49076

  • Local Institution - 0367

    Regensburg, 93053

  • Local Institution - 0387

    Sande, 26452

  • Local Institution

    Siegen, 57076

  • Local Institution - 0391

    Sindelfingen, Baden-Wurttemberg, 71065

  • Local Institution - 0045

    Tübingen, Baden-Wurttemberg, 72076

  • Local Institution - 0241

    Ulm, 89081

Other trials in Germany

Spain26 sites

  • Local Institution - 0141

    A Coruña, 15006

  • Local Institution - 0026

    Albacete, 02006

  • Local Institution - 0052

    Badalona, 08916

  • Local Institution - 0012

    Barcelona, 08003

  • Local Institution - 0010

    Barcelona, 08035

  • Local Institution - 0027

    Barcelona, 08036

  • Local Institution - 0385

    Córdoba, 14004

  • Local Institution - 0400

    Donostia / San Sebastian, 20014

  • Local Institution - 0426

    Girona, 17007

  • Local Institution - 0176

    L'Hospitalet de Llobregat, 08907

  • Local Institution - 0372

    León, Castille and León, 24071

  • Local Institution - 0249

    Lleida, 25008

  • Local Institution - 0238

    Madrid, 28007

  • Local Institution - 0025

    Madrid, 28034

  • Local Institution - 0413

    Madrid, 28041

  • Local Institution - 0384

    Madrid, 28046

  • Local Institution - 0159

    Sabadell, Barcelona, 08208

  • Local Institution - 0163

    Sant Joan Despí, Barcelona, 08970

  • Local Institution - 0425

    Santiago de Compostela, 15706

  • Local Institution - 0158

    Seville, 41009

  • Local Institution - 0177

    Seville, 41013

  • Local Institution - 0164

    Tarragona, 43005

  • Local Institution - 0150

    Terrassa, 08222

  • Local Institution - 0147

    Valencia, 46026

  • Local Institution - 0014

    Valladolid, 47005

  • Local Institution - 0418

    Vigo, 36312

Other trials in Spain

Greece25 sites

  • Local Institution - 0438

    Athens, Attica, 115 21

  • Local Institution - 0370

    Athens, 106 76

  • Local Institution - 0436

    Athens, 11525

  • Local Institution - 0440

    Athens, 11526

  • Local Institution - 0373

    Athens, 11527

  • Local Institution

    Athens, 11527

  • Local Institution - 0209

    Athens, 11528

  • Local Institution - 0283

    Athens, 11528

  • Local Institution - 0351

    Athens, 12461

  • Local Institution - 0407

    Crete, 71110

  • Local Institution

    Ioannina, 45445

  • Local Institution - 0357

    Larissa, Larisa, 41110

  • Local Institution - 0161

    Larissa, 41110

  • Local Institution - 0441

    Larissa, 41221

  • Local Institution - 0333

    Loanniana, 45500

  • Local Institution - 0365

    Loanniana, 45500

  • Local Institution - 0439

    Neo Faliro, 18547

  • Local Institution - 0371

    Pátrai, 26500

  • Local Institution - 0208

    Pireaus, 18536

  • Local Institution - 0405

    Thessaloniki, 54621

  • Local Institution - 0269

    Thessaloniki, 54636

  • Local Institution - 0389

    Thessaloniki, 54636

  • Local Institution - 0444

    Thessaloniki, 54642

  • Local Institution - 0210

    Thessaloniki, 56403

  • Local Institution - 0445

    Thessaloniki, 57010

Other trials in Greece

South Korea20 sites

  • Local Institution - 0081

    Anyang, 431-070

  • Local Institution - 0109

    Busan, 49201

  • Local Institution - 0166

    Busan, 49241

  • Local Institution - 0179

    Daegu, 41944

  • Local Institution - 0102

    Daegu, 42415

  • Local Institution

    Daegu, 700-712

  • Local Institution - 0094

    Goyang-si, Gyeonggido, 10380

  • Local Institution - 0105

    Gwangju, 61469

  • Local Institution - 0101

    Incheon, 22332

  • Local Institution - 0153

    Seongnam-si, 13620

  • Local Institution - 0088

    Seoul, Seoul Teugbyeolsi, 05505

  • Local Institution - 0087

    Seoul, 01830

  • Local Institution - 0185

    Seoul, 02447

  • Local Institution - 0071

    Seoul, 03080

  • Local Institution - 0080

    Seoul, 03722

  • Local Institution - 0120

    Seoul, 04763

  • Local Institution - 0145

    Seoul, 06273

  • Local Institution - 0152

    Seoul, 07061

  • Local Institution - 0112

    Seoul, 08308

  • Local Institution - 0091

    Seoul, 130-710

Other trials in South Korea

France17 sites

  • Local Institution - 0051

    Bordeaux, 33000

  • Local Institution

    Bourg-en-Bresse, 01012

  • Local Institution - 0165

    Brest, 29200

  • Local Institution - 0174

    Caen, 14033

  • Local Institution

    Créteil, 94010

  • Local Institution - 0048

    Lille, Nord, 59037

  • Local Institution

    Limoges, 87042

  • Local Institution - 0168

    Marseille, 13385

  • Local Institution - 0442

    Montpellier, Hérault, 34295

  • Local Institution - 0297

    Nancy, 54035

  • Local Institution - 0205

    Nîmes, 30029

  • Local Institution - 0049

    Paris, 75010

  • Local Institution

    Paris, 75013

  • Local Institution - 0126

    Paris, 75019

  • Local Institution - 0028

    Paris, 75877

  • Local Institution - 0107

    Rouen, 76031

  • Local Institution - 0355

    Toulouse, 31059

Other trials in France

Poland15 sites

  • Local Institution - 0350

    Bydgoszcz, 85-094

  • Local Institution - 0216

    Chełm, 22-100

  • Local Institution - 0206

    Gdansk, 80-803

  • Local Institution

    Gmina Końskie, 26-200

  • Local Institution - 0181

    Grodzisk Mazowieciki, 05-825

  • Local Institution - 0253

    Katowice, 40-635

  • Local Institution - 0197

    Lodz, 93-113

  • Local Institution - 0198

    Olsztyn, 10-561

  • Local Institution - 0215

    Sandomierz, 27-600

  • Local Institution - 0183

    Skarżysko-Kamienna, 26-110

  • Local Institution - 0225

    Wałcz, 78-600

  • Local Institution - 0265

    Warsaw, Masovian Voivodeship, 04-141

  • Local Institution

    Warsaw, 02-097

  • Local Institution - 0214

    Warsaw, 02-957

  • Local Institution - 0212

    Wejherowo, 84-200

Other trials in Poland

United Kingdom15 sites

  • Local Institution - 0140

    Aberdeen, AB25 2ZD

  • Local Institution

    Ashford, TN24 0LZ

  • Local Institution - 0157

    Bath, BA1 3NG

  • Local Institution - 0222

    Canterbury, Kent, CT1 3NG

  • Local Institution - 0089

    Chester, CH2 1UL

  • Local Institution - 0221

    Edinburgh, EH16 4SA

  • Local Institution - 0096

    Glasgow, G51 4TF

  • Local Institution - 0361

    Lancashire, BL9 7TD

  • Local Institution

    London, SE5 9RF

  • Local Institution

    London, W1T 7HA

  • Local Institution - 0303

    Luton, LU4 0DZ

  • Local Institution

    Nottingham, NG5 1PB

  • Local Institution - 0431

    Salford, M6 8HD

  • Local Institution - 0414

    Sheffield, S10 2JF

  • Local Institution - 0307

    Staffordshire, ST4 6QG

Other trials in United Kingdom

Canada14 sites

  • Local Institution - 0057

    Calgary, Alberta, T2N 2T9

  • Local Institution - 0326

    Chicoutimi, Quebec, G7H 5H6

  • Local Institution - 0061

    Edmonton, Alberta, T6G 2G3

  • Local Institution - 0155

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution - 0054

    Hamilton, Ontario, L8L 2X2

  • Local Institution

    Kingston, Ontario, K7L 2V7

  • Local Institution - 0059

    Lethbridge, Alberta, T1J 0N9

  • Local Institution - 0227

    London, Ontario, N6A 5A5

  • Local Institution - 0066

    Montreal, Quebec, H4A3J1

  • Local Institution - 0369

    New Westminster, British Columbia, V3L 0E3

  • Local Institution - 0064

    Québec, Quebec, G1J 1Z4

  • Local Institution - 0124

    Toronto, Ontario, M4N 3M5

  • Local Institution

    Toronto, Ontario, M5B 1W8

  • Local Institution - 0121

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy14 sites

  • Local Institution - 0151

    Ancona, The Marches, 60020

  • Local Institution - 0156

    Bologna, 40133

  • Local Institution - 0290

    Cagliari, 09134

  • Local Institution - 0359

    Genoa, Liguria, 16132

  • Local Institution - 0095

    Milan, 20132

  • Local Institution - 0104

    Modena, 1355-41126

  • Local Institution - 0149

    Negrar, Veneto, 37024

  • Local Institution - 0084

    Pavia, Lombardy, 27100

  • Local Institution - 0085

    Perugia, 06012

  • Local Institution - 0114

    Perugia, 06129

  • Local Institution - 0108

    Roma, 00152

  • Local Institution - 0129

    Roma, 00161

  • Local Institution - 0083

    Verona, 37126

  • Local Institution - 0123

    Vibo Valentia, 89900

Other trials in Italy

Hungary13 sites

  • Local Institution - 0134

    Budapest, 1083

  • Local Institution - 0077

    Budapest, 1106

  • Local Institution - 0119

    Budapest, 1134

  • Local Institution - 0136

    Budapest, 1145

  • Local Institution - 0154

    Debrecen, 4032

  • Local Institution - 0079

    Győr, 9024

  • Local Institution - 0175

    Kistarcsa, 02143

  • Local Institution - 0437

    Kisvárda, 4600

  • Local Institution - 0070

    Miskolc, BZ, 3526

  • Local Institution - 0220

    Nyíregyháza, 4400

  • Local Institution - 0138

    Pécs, 7624

  • Local Institution - 0133

    Szeged, 6725

  • Local Institution - 0137

    Zalaegerszeg, 8900

Other trials in Hungary

Belgium12 sites

  • Local Institution

    Brasschaat, 2930

  • Local Institution - 0284

    Bruges, 8000

  • Local Institution - 0196

    Brussels, Brussels Capital, 1090

  • Local Institution - 0427

    Brussels, 1020

  • Local Institution - 0305

    Brussels, 1070

  • Local Institution - 0190

    Brussels, 1200

  • Local Institution - 0122

    Edegem, Antwerpen, 2650

  • Local Institution - 0199

    Ghent, 9000

  • Local Institution - 0103

    Kortrijk, 8500

  • Local Institution - 0098

    Leuven, 3000

  • Local Institution - 0178

    Liège, 4000

  • Local Institution - 0192

    Yvoir, Namur, 5530

Other trials in Belgium

China12 sites

  • Local Institution

    Beijing, Beijing Municipality, 100070

  • Local Institution

    Changchun, Jilin, 130021

  • Local Institution

    Daqing, Heilongjiang, 163001

  • Local Institution

    Guangzhou, Guangdong, 510080

  • Local Institution

    Haikou, Hainan, 570311

  • Local Institution

    Nantong, Jiangsu, 226001

  • Local Institution

    Qingdao, Shandong, 266000

  • Local Institution

    Shenyang, Liaoning, 110016

  • Local Institution

    Wenzhou, Zhejiang, 325000

  • Local Institution

    Yangzhou, Jiangsu, 225001

  • Local Institution

    Yantai, Shandong, 264000

  • Local Institution

    Zhengzhou, Henan, 450052

Other trials in China

Brazil11 sites

  • Local Institution - 0245

    Botucatu, São Paulo, 18618-686

  • Local Institution - 0065

    Campinas, São Paulo, 13083-970

  • Local Institution - 0314

    Curitiba, Paraná, 80060-900

  • Local Institution - 0072

    Fortaleza, Ceará, 60175-295

  • Local Institution - 0219

    Joinville, Santa Catarina, 89202 165

  • Local Institution - 0200

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution

    Ribeirão Preto, São Paulo, 14051-140

  • Local Institution - 0113

    Santo André, São Paulo, 09030-010

  • Local Institution - 0234

    São Paulo, São Paulo, 01221-020

  • Local Institution - 0248

    São Paulo, São Paulo, 04024-002

  • Local Institution - 0275

    Uberaba, Minas Gerais, 38025-260

Other trials in Brazil

Argentina10 sites

  • Local Institution - 0100

    Adrogué, Buenos Aires, B1846DSK

  • Local Institution

    Buenos Aires, 1437

  • Local Institution - 0068

    Buenos Aires, C1425DND

  • Local Institution

    Buenos Aires, C1425

  • Local Institution - 0063

    CABA, Buenos Aires, C1199ABB

  • Local Institution - 0076

    CABA, Buenos Aires, C1428AQK

  • Local Institution - 0067

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1180AAX

  • Local Institution - 0237

    Lomas de Zamora, Buenos Aires, 1832

  • Local Institution - 0435

    Recoleta, Buenos Aires, C1115AAB

  • Local Institution

    Santa Fe, 3000

Other trials in Argentina

Israel10 sites

  • Local Institution

    Beersheba, 85025

  • Local Institution - 0139

    Haifa, 3109601

  • Local Institution - 0349

    Haifa, 34362

  • Local Institution - 0193

    Jerusalem, 9103102

  • Local Institution

    Jerusalem, 91031

  • Local Institution - 0078

    Jerusalem, 91120

  • Local Institution - 0308

    Nahariya, 22100

  • Local Institution - 0247

    Petah Tikva, 49100

  • Local Institution - 0204

    Ramat Gan, 52621

  • Local Institution - 0086

    Tel Aviv, 64239

Other trials in Israel

Australia8 sites

  • Local Institution - 0399

    Adelaide, South Australia, 5000

  • Local Institution - 0358

    Clayton, Victoria, 3168

  • Local Institution - 0281

    Heidelberg, Victoria, 3084

  • Local Institution - 0397

    Launceston, Tasmania, 7250

  • Local Institution - 0315

    Murdoch, Western Australia, 6150

  • Local Institution - 0329

    Randwick, New South Wales, 2031

  • Local Institution - 0287

    Southport, Queensland, 4215

  • Local Institution - 0360

    Sydney, New South Wales, 2170

Other trials in Australia

Russia8 sites

  • Local Institution - 0277

    Barnaul, 656038

  • Local Institution - 0260

    Kemerovo, 650002

  • Local Institution - 0306

    Moscow, 117593

  • Local Institution

    Moscow, 125367

  • Local Institution - 0268

    Novosibirsk, 630087

  • Local Institution - 0356

    Saint Petersburg, 194354

  • Local Institution - 0202

    Smolensk, 214018

  • Local Institution

    Yaroslavl, 150030

Other trials in Russia

Czechia6 sites

  • Local Institution

    Brno, 656 91

  • Local Institution

    České Budějovice, 370 87

  • Local Institution - 0348

    Jihlava, Vysocina, 586 01

  • Local Institution - 0401

    Olomouc, Olomouc Region, 779 00

  • Local Institution - 0023

    Ostrava, 703 00

  • Local Institution - 0339

    Prague, 128 08

Other trials in Czechia

Mexico6 sites

  • Local Institution - 0394

    Culiacán, Sinaloa, 80020

  • Local Institution - 0366

    Durango, 34217

  • Local Institution - 0396

    Guadalajara, Jalisco, 44670

  • Local Institution

    Mexico City, Mexico City, 14080

  • Local Institution - 0398

    Mexico City, Mexico City, 14269

  • Local Institution - 0404

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Norway6 sites

  • Local Institution - 0368

    Bergen, 5021

  • Local Institution - 0383

    Grålum, 1714

  • Local Institution

    Kristiansand, 4604

  • Local Institution - 0130

    Lørenskog, 1478

  • Local Institution - 0408

    Oslo, 0424

  • Local Institution - 0330

    Stavanger, 4068

Other trials in Norway

Switzerland6 sites

  • Local Institution - 0162

    Aarau, 5001

  • Local Institution - 0118

    Basel, Basel-Stadt (de), 4031

  • Local Institution - 0115

    Bern, Bern (de), 3010

  • Local Institution - 0203

    Geneva, 1205

  • Local Institution - 0201

    Lausanne, 1011

  • Local Institution

    Zurich, 8032

Other trials in Switzerland

Denmark5 sites

  • Local Institution - 0217

    Aalborg, 9000

  • Local Institution - 0127

    Aarhus N, 8200

  • Local Institution - 0142

    Copenhagen, 2400

  • Local Institution - 0110

    Glostrup Municipality, 2600

  • Local Institution - 0117

    Herlev, Capital, 2730

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Sweden5 sites

  • Local Institution - 0171

    Gothenburg, SE-43146

  • Local Institution - 0191

    Hässleholm, 28125

  • Local Institution - 0128

    Malmö, Skåne County, SE-205 02

  • Local Institution - 0224

    Umeå, 901 87

  • Local Institution - 0132

    Uppsala, SE-752 37

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Austria4 sites

  • Local Institution - 0184

    Klagenfurt, 9020

  • Local Institution

    Sankt Pölten, 3100

  • Local Institution - 0273

    Vienna, 1160

  • Local Institution - 0106

    Vöcklabruck, 4840

Other trials in Austria

Chile4 sites

  • Local Institution

    Los Ángeles, 441055

  • Local Institution - 0131

    Valdivia, 5090145

  • Local Institution - 0172

    Viña del Mar, Valparaiso, 2520612

  • Local Institution - 0167

    Viña del Mar, 0

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Finland3 sites

  • Local Institution - 0111

    Helsinki, 290

  • Local Institution - 0341

    Lappeenranta, 53130

  • Local Institution - 0143

    Turku, FI-20520

Other trials in Finland

Hong Kong1 site

  • Local Institution

    Hong Kong

Other trials in Hong Kong

About this study

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)

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.

Being tested
BMS-986177, Placebo, Clopidogrel, Aspirin
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986177Drug

    Oral administration

  • PlaceboOther

    Oral Administration

  • ClopidogrelDrug

    Oral administration

  • AspirinDrug

    Oral administration

Study groups in NCT03766581
Study groupRoleWhat they receive
BMS-986177 PlaceboPlacebo comparatorSpecified Dose on Specified Days
Receives: Other: Placebo; Drug: Clopidogrel; Drug: Aspirin
Dose 1: BMS-986177 + Aspirin + ClopidogrelExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin
Dose 2: BMS-986177 + Aspirin + ClopidogrelExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin
Dose 3: BMS-986177 + Aspirin + ClopidogrelExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin
Dose 4: BMS-986177 + Aspirin + ClopidogrelExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin
Dose 5: BMS-986177 + Aspirin + ClopidogrelExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin
Dose 6: BMS-986177 + Aspirin + ClopidogrelExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin
Dose 7: BMS-986177 + Aspirin + ClopidogrelExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From randomization to up to 90 days after randomization

Secondary outcomes (21)

  1. Percent of Participants With Major Bleeding According to BARC Type 3 and 5

    Percent of participants with major bleeding based on the Bleeding Academic Research Consortium (BARC) Types 3 and 5 definitions. BARC bleeding types:

    3a = Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL transfusion with overt bleeding 3b = Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3c = Intracranial hemorrhage, 5a = Probable fatal bleeding 5b = Definite fatal bleeding

    Measured: From first dose to up to 107 days after first dose

  2. Number of Participants With Bleeding Based on BARC Types 1-5

    Number of participants with bleeding based on Bleeding Academic Research Consortium (BARC) Type 1 to 5. BARC bleeding types: 0=No bleeding. 1=Not actionable bleeding. 2=Overt, actionable sign of hemorrhage requiring nonsurgical, medical intervention by a health-care professional, leading to hospitalization or increased level of care, or prompting evaluation. 3a=Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL. 3b=Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring IV vasoactive agents. 3c=Intracranial hemorrhage; intraocular bleed compromising vision. 4=CABG-related bleeding, perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy to control bleeding, transfusion of ≥5 U whole blood or packed red blood cells within a 48-hour period, chest tube output more than or equal to 2L within a 24-hour period. 5a=Probable fatal bleeding. 5b=Definite fatal bleeding.

    Measured: From first dose to up to 107 days after first dose

  3. Number of Participants With Bleeding Based on ISTH-Defined Criteria

    Number of participants with bleeding based on International Society on Thrombosis and Hemostasis (ISTH). ISTH Bleeding Types: 1) Fatal bleeding and/or 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome and/or 3) Bleeding causing a fall in hemoglobin level of ≥2 g/dL, or leading to transfusion of ≥2 units of whole blood or red cells.

    Measured: From first dose to up to 107 days after first dose

  4. Number of Participants With Bleeding Based on PLATO-Defined Criteria

    Number of participants with bleeding based on Platelet Inhibition and Patient Outcomes (PLATO) defined criteria. PLATO bleeding definitions:

    1. Major Life-threatening: Fatal, Intracranial, Intrapericardial with cardiac tamponade, Resulting in hypovolemic shock or severe hypotension that requires pressors or surgery, Clinically overt or apparent bleeding associated with decrease in hemoglobin >5 g/dL, Requiring transfusion of ≥4 U whole blood or packed red blood cells (PRBCs)
    2. Other Major: Significantly disabling (eg, intraocular with permanent vision loss), Associated drop in hemoglobin of 3 to 5 g/dL, Requiring transfusion of 2 to 3 U whole blood or PRBCs
    3. Any Major: Any one of the above criteria
    4. Minor: Bleeding that does not meet criteria for PLATO Major bleeding, and requiring medical intervention

    Measured: From first dose to up to 107 days after first dose

  5. 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

    Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90.

    Measured: From randomization to up to 90 days after randomization

  6. Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death

    Composite of percent of participants of new ischemic stroke, (Myocardial Infarction) MI and all cause death.

    Measured: From randomization to up to 90 days after randomization

  7. National Institutes of Health Stroke Scale (NIHSS)

    The NIHSS is an 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke participant is.

    Measured: At baseline, on Days 21 and 90, and at the time of a new stroke event

  8. Modified Rankin Scale (mRS)

    The Modified Rankin Score (mRS) is a 6-point disability scale with possible scores ranging from 0 to 6.

    0 = No symptoms at all

    1. = No significant disability despite symptoms; able to carry out all usual duties and activities
    2. = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. = Moderate disability; requiring some help, but able to walk without assistance
    4. = Moderately severe disability; unable to walk and attend to bodily needs without assistance
    5. = Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. = Dead

    Measured: At baseline, on Days 21 and 90, and at the time of a new stroke event

  9. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a survey with a summed score. MoCA score ranges between a lowest score of 0 to a highest score of 30. A score of:

    • ≥26 points: indicates normal cognitive function
    • 18-25 points: Mild cognitive impairment
    • 10-17 points: Moderate cognitive impairment
    • fewer than 10 points: Severe cognitive impairment

    Measured: At baseline, on Days 21 and 90, and at the time of a new stroke event

  10. Digit Symbol Substitution Test (DSST)

    The Descriptive Summary of the Digit Symbol Substitution Test (DSST) is a scale item, with a lowest score of 0 and highest total score of 135. Higher score indicates better cognitive functioning.

    Measured: At baseline, on Days 21 and 90, and at the time of a new stroke event

  11. Number of Participants With Adverse Events (AEs)

    AE: include all non-serious adverse events with onset on or after first dose date and within 2 days after the last dose of study treatment.

    Measured: From first dose to 2 days after last dose of study therapy (up to approximately 107 days)

  12. Number of Participants With Clinically Significant Vital Sign Abnormalities

    Number of participants with clinically significant vital sign abnormalities. Vital signs included heart rate and diastolic and systolic blood pressure.

    Measured: From first dose to up to 90 days after first dose

  13. Number of Participants With Clinically Significant Physical Examination Abnormalities

    Number of participants with clinically significant physical examination abnormalities.

    Measured: From first dose to up to 90 days after first dose

  14. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

    Number of participants with clinically significant ECG abnormalities.

    Measured: From first dose to up to 90 days after first dose

  15. Number of Participants With Clinically Significant Laboratory Abnormalities - Liver

    The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.

    Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)

    Measured: From first dose to up to approximately 38 months

  16. Percent Change From Baseline in aPTT Activity

    Percent change from baseline in activated partial thromboplastin time (aPTT) activity via exposure response.

    Measured: Baseline and day 90

  17. Percent Change From Baseline in Factor XI Clotting Activity

    Percent change from baseline in factor XI clotting activity via exposure response.

    Measured: Baseline and day 90

  18. Pharmacokinetic Parameter - Estimated Clearance (CL)

    Pharmacokinetic Parameter - Estimated Clearance (CL). CL is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.

    Measured: From first dose to up to 90 days after first dose

  19. Pharmacokinetic Parameter - Volume of the Central Compartment (VC)

    Pharmacokinetic Parameter - Volume of the Central Compartment (VC). VC is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.

    Measured: From first dose to up to 90 days after first dose

  20. Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI

    Total volume of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.

    Measured: At day 90

  21. Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI

    Number of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.

    Measured: At day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2018
  2. Study start27 Jan 2019
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03766581
Sponsor's protocol ID
CV010-031
Acronym
AXIOMATIC-SSP
Status last verified
Jun 2023
First submitted
13 Nov 2018
Last updated
12 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sharma M, Molina CA, Toyoda K, Bereczki D, Bangdiwala SI, Kasner SE, Lutsep HL, Tsivgoulis G, Ntaios G, Czlonkowska A, Shuaib A, Amarenco P, Endres M, Yoon BW, Tanne D, Toni D, Yperzeele L, von Weitzel-Mudersbach P, Sampaio Silva G, Avezum A, Dawson J, Strbian D, Tatlisumak T, Eckstein J, Ameriso SF, Weber JR, Sandset EC, Goar Pogosova N, Lavados PM, Arauz A, Gailani D, Diener HC, Bernstein RA, Cordonnier C, Kahl A, Abelian G, Donovan M, Pachai C, Li D, Hankey GJ. Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomised, double-blind, placebo-controlled, dose-finding trial. Lancet Neurol. 2024 Jan;23(1):46-59. doi: 10.1016/S1474-4422(23)00403-9.

    PubMed 38101902

  • Whiteson HZ, Frishman WH. Factor XI/XIa Inhibitors: A New Approach to Anticoagulation. Cardiol Rev. 2025 Jul-Aug 01;33(4):306-311. doi: 10.1097/CRD.0000000000000624. Epub 2023 Dec 1.

    PubMed 38038437

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986177, Clopidogrel and Aspirin in people with Acute Ischemic Stroke and Transient Ischemic Attack (TIA), run by Bristol-Myers Squibb at 424 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 424 sites in United States, Japan, Germany, Spain, Greece and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: From randomization to up to 90 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03766581, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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