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出境医 / 临床实验 / Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE (HOKUSAIpostVTE)
Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE (HOKUSAIpostVTE)
Study Description
Brief Summary:
The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting.
| Condition or disease | Intervention/treatment |
|---|---|
| Venous Thromboembolic Disease Post Thrombotic Syndrome Chronic Thromboembolic Pulmonary Hypertension Quality of Life | Other: Observation |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE |
| Actual Study Start Date : | April 25, 2017 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Patients treated with heparin+edoxaban for VTE
Patients treated with heparin+edoxaban for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised.
|
Other: Observation
No intervention
|
|
Patients treated with heparin+VKA for VTE
Patients treated with heparin+VKA for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised.
|
Other: Observation
No intervention
|
Outcome Measures
Primary Outcome Measures :
- Post thrombotic syndrome (PTS) [ Time Frame: up to 10 years ]PTS according to Villalta
Secondary Outcome Measures :
- Chronic thromboembolic pulmonary hypertension (CTEPH) [ Time Frame: up to 10 years ]according to clinical and objective criteria
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE.
Criteria
Inclusion Criteria:
- Participant in the HOKUSAI VTE trial
Exclusion Criteria:
- None
Contacts and Locations
Contacts
| Contact: Ingrid Bistervels, MD | +31205665976 | i.m.bistervels@amc.uva.nl | |
| Contact: Roisin Bavalia, MD | 0031 205667516 | r.bavalia@amc.uva.nl |
Locations
| Netherlands | |
| Academisch Medisch Centrum | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 1, 2019 | ||||||||
| First Posted Date | July 5, 2019 | ||||||||
| Last Update Posted Date | July 5, 2019 | ||||||||
| Actual Study Start Date | April 25, 2017 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Post thrombotic syndrome (PTS) [ Time Frame: up to 10 years ] PTS according to Villalta
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
Chronic thromboembolic pulmonary hypertension (CTEPH) [ Time Frame: up to 10 years ] according to clinical and objective criteria
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE | ||||||||
| Official Title | Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE | ||||||||
| Brief Summary | The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE. | ||||||||
| Condition |
|
||||||||
| Intervention | Other: Observation
No intervention
|
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| Study Groups/Cohorts |
|
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| 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 |
1200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2020 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||||||
| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
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| Listed Location Countries | Netherlands | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04007653 | ||||||||
| Other Study ID Numbers | HOKUSAI post VTE study | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | S. Middeldorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ||||||||
| Study Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ||||||||
| Verification Date | July 2019 | ||||||||
