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NCT Number: NCT02828904

RIVET - Retrospective Cohort Study on the Risk of Venous Thromboembolism

The risk of venous thromboembolism (VTE) associated with the use of chlormadinone acetate (CMA) compared to the gold-standard progestin levonorgestrel (LNG) as component of combined oral contraceptives (COC) is currently unknown. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended a pooled analysis of four prospective cohort studies carried out by the Berlin Center for Epidemiology and Health Research (ZEG Berlin) in order to clarify whether CMA-containing COCs carry a different VTE risk compared to LNG-containing COCs.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Center for Epidemiology and Health Research Berlin

Berlin, 10115, Germany

About this study

This study is designed as a retrospective cohort study. ZEG Berlin conducted several large prospective cohort studies on the risk of VTE associated with the use of hormonal contraceptives. Four of these studies included a substantial number of women using CMA/EE or LNG/EE-containing COCs. For this study, the data on CMA/EE and LNG/EE from the following four prospective cohort studies are combined: 1) EURAS-OC/LASS 2) INAS-OC 3) INAS-SCORE and 4) INAS-FOCUS.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion: female, 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), applied COCs: CMA/EE or LNG/EE.

Exclusion of women with a personal history of VTE.

Treatment and study plan

Primary outcomes

  1. The risk of venous thromboembolic events (VTE) in the cohort of users of combined oral contraceptives (COCs) containing 2 mg CMA/30 µg EE compared to 0.15 mg LNG/30 µg EE.

    Time frame: VTEs will be identified during the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.

    VTE risk of users of CMA 2mg / EE 30µg compared to the VTE risk of users of LNG 0.15 mg / EE 30µg.

Secondary outcomes

  1. To assess the risk of venous thromboembolic events stratified by: COC user type, age and BMI

    Time frame: During the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.

  2. To assess the risk of VTE in the sub-cohort of users of COCs containing CMA compared to LNG both combined with ≤30 µg EE.

    Time frame: During the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.

  3. To characterize the baseline risk of users of the two formulations (lifetime history of co-morbidity, prognostic factors for VTE, co-medication, socio-demographic and life¬style data).

    Time frame: During the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.

Sponsors and collaborators

Lead sponsor

Center for Epidemiology and Health Research, Germany

Other

Registry information

Official study title

Retrospective Cohort Study on the RIsk of VEnous Thromboembolism Associated With the Use of Combined Oral Contraceptives Containing Chlormadinone Acetate/Ethinylestradiol and Levonorgestrel/Ethinylestradiol

Acronym: RIVET-RCS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2016
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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