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Trial record 1 of 1 for:    NCT04435769
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Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment

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ClinicalTrials.gov Identifier: NCT04435769
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 15, 2020
First Posted Date June 17, 2020
Last Update Posted Date September 22, 2020
Actual Study Start Date August 4, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2020)
Description of direct costs related to warfarin/apixaban treatment [ Time Frame: 6 months ]
Description of direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment
Official Title Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment
Brief Summary To describe the direct costs related to warfarin/apixaban treatment
Detailed Description To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.
Condition Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts
  • Non-valvular Atrial Fibrillation (NVAF) on warfarin
    The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.
  • Non-valvular Atrial Fibrillation (NVAF) on apixaban
    The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.
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 Recruiting
Estimated Enrollment
 (submitted: June 15, 2020)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of non-valvular atrial fibrillation (NVAF);
  • New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
  • Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
  • Apixaban arm: genetically determined higher sensitivity to warfarin;
  • Patients whose status allowed oral treatment with apixaban/warfarin;
  • Age ≥ 18;
  • Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.

Exclusion Criteria:

  • Diagnosis of valvular disease;
  • Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
  • Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
  • Contraindications according SmPC of Eliquis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Czechia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04435769
Other Study ID Numbers B0661121
APIXABAN SECOND LINE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2020