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)

CompletadoFase 2ClinicalTrials.gov

ID: NCT03766581Tipo: INTERVENTIONALInicio: 27 de ene de 2019Fin estimado: 31 de mar de 2022

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

BMS-986177

Oral administration

other

Placebo

Oral Administration

drug

Clopidogrel

Oral administration

drug

Aspirin

Oral administration

Ubicaciones

Local Institution - 0100

Adrogué, Buenos Aires, Argentina

Local Institution - 0063

CABA, Buenos Aires, Argentina

Local Institution - 0076

CABA, Buenos Aires, Argentina

Local Institution - 0067

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0237

Lomas de Zamora, Buenos Aires, Argentina

Local Institution - 0435

Recoleta, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution - 0068

Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Santa Fe, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorJanssen, LP

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