Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 79 of 412 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Oral Factor XIa Inhibitor for the Prevention of New Ischemic Stroke in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA) (AXIOMATIC-SSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766581
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Composite of new ischemic stroke and new covert brain infarction (FLAIR+DWI) during the treatment period [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03766581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: 90 days ]
  • Event rate based on BARC, ISTH and PLATO-defined criteria [ Time Frame: 90 days ]
  • Rate of the composite of new ischemic stroke and new covert brain infarction (FLAIR + DWI) during the treatment period detected by MRI at 90 days [ Time Frame: 90 days ]
  • Percent change from baseline in aPTT and Factor XI clotting activity during treatment [ Time Frame: 90 days ]
  • Percent change from baseline in Factor XI [ Time Frame: 90 days ]
  • Location of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI
  • Number of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI
  • Volume of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI
  • National Institute of Health Stroke Scale (NIHSS) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Modified Rankin Scale (mRS) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Montreal Cognitive Assessment (MoCA) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Digit Symbol Substitution Test (DSST) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Estimated clearance (CL) [ Time Frame: 90 days ]
    CL will be described using descriptive statistics
  • Volume of distribution (Vd) [ Time Frame: 90 days ]
    Vd will be described using descriptive statistics
  • Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction during the treatment period [ Time Frame: 90 days ]
  • Event rates for all cause-death during the treatment period [ Time Frame: 90 days ]
  • Incidence of AE's and SAE's [ Time Frame: 90 days ]
    BMS-986177
  • Distribution of clinical characteristics [ Time Frame: 90 days ]
    BMS-986177 clinical characteristics will be summarized using descriptive statistics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Factor XIa Inhibitor for the Prevention of New Ischemic Stroke in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)
Official Title  ICMJE A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Response-Adaptive 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)
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. The safety of this treatment will also be studied.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Dose ranging study using RAR (Response Adaptive Randomization) design
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Ischemic Stroke
  • Transient Ischemic Attack (TIA)
Intervention  ICMJE
  • Drug: BMS-986177
    Oral administration
  • Other: BMS-986177 Placebo
    Oral Administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Study Arms  ICMJE
  • Placebo Comparator: BMS-986177 Placebo
    100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 A
    25 mg BMS-986177 QD (daily) + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 B
    25 mg BMS-986177 BID (twice daily) + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 C
    50 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 D
    50 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 E
    100 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 F
    100 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 G
    200 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: BMS-986177 H
    200 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
    Interventions:
    • Drug: BMS-986177
    • Other: BMS-986177 Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 acute ischemic stroke event

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03766581
Other Study ID Numbers  ICMJE CV010-031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Janssen, LP
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP