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Trial record 1 of 1 for:    NCT04618913
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Anticoagulation in Patients With Venous Thromboembolism and Cancer (VICTORIE)

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ClinicalTrials.gov Identifier: NCT04618913
Recruitment Status : Active, not recruiting
First Posted : November 6, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 1, 2020
First Posted Date November 6, 2020
Last Update Posted Date February 9, 2021
Actual Study Start Date December 14, 2020
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2020)
Recurrence of Thromboembolism [ Time Frame: 6 Months after treatment began as early as 1/1/2013 ]
The follow-up period during which outcome events of interest will be identified will run from the day after the index date until the end of the data collection or death, whichever occurs first. As data are updated at different times and frequencies in the different study countries, the date of the end of data collection will be determined after the relevant permissions have been acquired from the respective authorities.
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 Anticoagulation in Patients With Venous Thromboembolism and Cancer
Official Title VICTORIE (VTE In Cancer - Treatment, Outcomes and Resource Use In Europe)
Brief Summary This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns,healthcare resource utilisation (HCRU), direct and indirect costs (where feasible), and safety and effectiveness outcomes in patients with VTE and active cancer or patients with VTE and history of cancer who initiate anticoagulant treatment with a VKA, LMWH or NOACs.
Detailed Description Not Provided
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 Adult patients with a diagnosis of (VTE) venous thromboembolism and active cancer, or a history of cancer, being treated with anticoagulation.
Condition
  • Neoplasms
  • Embolism
Intervention
  • Drug: Apixaban
    Anticoagulant
  • Drug: Rivaroxaban
    Anticoagulant
  • Drug: Edoxaban
    Edoxaban
  • Drug: Dabigatran
    Dabigatran
  • Drug: VKA
    Vitamin K antagonist
  • Drug: LMWH
    Low Molecular Weight Heparin
Study Groups/Cohorts
  • VTE and history of cancer
    VTE and history of cancer
    Interventions:
    • Drug: Apixaban
    • Drug: Rivaroxaban
    • Drug: Edoxaban
    • Drug: Dabigatran
    • Drug: VKA
    • Drug: LMWH
  • VTE and active cancer
    VTE and active cancer
    Interventions:
    • Drug: Apixaban
    • Drug: Rivaroxaban
    • Drug: Edoxaban
    • Drug: Dabigatran
    • Drug: VKA
    • Drug: LMWH
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 Active, not recruiting
Actual Enrollment
 (submitted: November 1, 2020)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • A VTE diagnosis
  • Active cancer or history of cancer
  • Treatment with VKA, NOAC (apixaban, rivaroxaban, dabigatran, edoxaban) or LMWH
  • Age ≥ 18 years at the date of index VTE (Venous thromboembolic)

Exclusion Criteria:

  • Prior VTE diagnosis
  • Diagnosis of prior atrial fibrillation
  • Inferior Vena Cava (IVC) filter
  • Prior exposure to (OAC) oral anticoagulation or (PAC)parenteral anticoagulation - note: Prophylactic use of (OAC)/(PAC) allowed.
  • Pregnancy
  • More than one (OAC) oral anticoagulation or (PAC) parenteral anticoagulation dispensed on the index date.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04618913
Other Study ID Numbers B0661150
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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 February 2021