We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    aristophanes and apixaban
Previous Study | Return to List | Next Study

Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation (ARISTOPHANES)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03087487
Recruitment Status : Active, not recruiting
First Posted : March 22, 2017
Last Update Posted : February 9, 2022
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.

Condition or disease
Non-Valvular Atrial Fibrillation

Layout table for study information
Study Type : Observational
Actual Enrollment : 434046 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-World Comparative Effectiveness Research and Related Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients Using Oral Anti-coagulants
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : September 30, 2015
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

NVAF patients on Warfarin
NVAF patients newly initiated with Warfarin. Non-Interventional.
NVAF patients on Apixaban
NVAF patients newly initiated on Apixaban. Non-Interventional.
NVAF patients on Dabigatran
NVAF patients newly initiated with Dabigatran. Non-Interventional.
NVAF patients on Rivaroxaban
NVAF patients newly initiated with Rivaroxaban. Non-Interventional.

Primary Outcome Measures :
  1. Time to first major bleeding event [ Time Frame: Up to 33 months ]
  2. Time to first stroke/systemic embolism (SE) event [ Time Frame: Up to 33 months ]

Secondary Outcome Measures :
  1. Major bleeding-related medical costs [ Time Frame: Up to 33 months ]
  2. Stroke/SE-related medical costs [ Time Frame: Up to 33 months ]
  3. All-cause Healthcare costs [ Time Frame: Up to 33 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NVAF patients who were initiators of warfarin or apixaban or dabigatran or rivaroxaban treatment from 01-Jan-2013 through 30-Sep-2015. All patients who have at least 1 year of baseline data available and no prior OAC use will be included in this study.

Inclusion Criteria:

  1. Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy claim date during the identification period will be designated as the index date
  2. Patients 18 years old or older as of the index date
  3. At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim
  4. At least 12 months of baseline period prior to index date with continuous enrollment

Exclusion Criteria:

  1. Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date
  2. Evidence of pregnancy during the study period
  3. Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period
  4. Had more than 1 oral anticoagulant claim on the index date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087487

Layout table for location information
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
Bristol-Myers Squibb
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03087487    
Other Study ID Numbers: CV185-543
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: January 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes