RIVET - Retrospective Cohort Study on the Risk of Venous Thromboembolism
NCT ID: NCT02828904
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
124000 participants
OBSERVATIONAL
2022-03-10
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long Term Outcomes of Venous Thromboembolism
NCT02268630
Intimate Partner Violence as a Risk Factor for Venous Thromboembolism in Women
NCT05890924
Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding
NCT04748393
Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure
NCT03206372
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
NCT02064439
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants will be identified retrospectively from a pooled dataset which comprises four large, controlled, prospective, non-interventional active surveillance studies that focused on the risk of VTE associated with the use of combined oral contraceptives. All data were prospectively collected by ZEG Berlin and follow the EURAS/INAS study design. Inclusion and exclusion criteria, the method of patient recruitment and follow-up as well as research methods were similar across studies.
The EURAS-OC/LASS study was conducted in Europe only; the other three studies are transatlantic studies that include subjects from both Europe and the United States of America.
This analysis is specifically designed to assess the risk of VTE associated with the use of COCs containing CMA/EE compared to LNG/EE.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Users of Chlormadinone Acetate (CMA) combined with Ethinylestradiol (EE)
CMA/EE users are defined as
* aged 15 to 49 years
* Participation in one of the 4 observational studies conducted between 2000 and 2019 (LASS/EURAS-OC, INAS-OC, INAS-SCORE, INAS-FOCUS)
* COC new user (starters, switchers, and re-starters)
No interventions assigned to this group
Users of Levonorgestrel (LNG) combined with Ethinylestradiol (EE)
LNG/EE users are defined as
* aged 15 to 49 years
* Participation in one of the 4 observational studies conducted between 2000 and 2019 (LASS/EURAS-OC, INAS-OC, INAS-SCORE, INAS-FOCUS)
* COC new user (starters, switchers, and re-starters)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
15 Years
49 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for Epidemiology and Health Research, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Klaas Heinemann, MD, PhD
PhD, MD, MSc, MBA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Epidemiology and Health Research Berlin
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZEG2014_05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.