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

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ClinicalTrials.gov Identifier: NCT03087487
Recruitment Status : Active, not recruiting
First Posted : March 22, 2017
Last Update Posted : October 16, 2018
Sponsor:
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

Study Type : Observational
Estimated Enrollment : 300000 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 : September 20, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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

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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.
Criteria

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


Locations
United States, Michigan
Statinmed Research
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03087487     History of Changes
Other Study ID Numbers: CV185-543
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes