Venous ThromboembolismRIVET-RCSNCT02828904
RIVET - Retrospective Cohort Study on the Risk of Venous Thromboembolism
An observational study of Venous Thromboembolism, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 124,000 participants
- Where
- 1 siteGermany
- Study dates
- 10 Mar 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Epidemiology and Health Research Berlin
Berlin, 10115
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
VTE risk of users of CMA 2mg / EE 30µg compared to the VTE risk of users of LNG 0.15 mg / EE 30µg.
Measured: VTEs will be identified during the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.
Secondary outcomes (3)
To assess the risk of venous thromboembolic events stratified by: COC user type, age and BMI
Measured: During the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.
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.
Measured: During the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.
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).
Measured: During the follow-up intervals, typically scheduled every 6 - 12 months, with a maximum follow-up of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start10 Mar 2022
- Primary completion15 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828904
- Sponsor's protocol ID
- ZEG2014_05
- Acronym
- RIVET-RCS
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2016
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02828904
- Acronym / sponsor ID
- RIVET-RCS / ZEG2014_05
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124,000 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
| 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) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.