Trial · NCT05022563
Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea
NCT05022563, Completed, Pfizer; results first posted 2023-08-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea. Trials, record NCT05022563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05022563
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea
- NCT number
- NCT05022563
- Status
- Completed
- Enrollment
- 55,759 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Venous Thromboembolism
- Interventions
- Parenteral anticoagulant, Warfarin, Apixaban, Rivaroxaban, Dabigatran, Edoxaban
- First posted
- 2021-08-26
- Last updated
- 2023-08-03
- Results first posted
- 2023-08-03
- Limitations and caveats
- Phase 2 was not conducted due to insufficient statistical power that would lead to small and imbalanced sample sizes in comparison groups.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Interruption in Index Anticoagulant Treatment | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Time to Treatment Interruption | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Number of Participants Who Switched to Another Anticoagulant Therapy | From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Time to Treatment Switch | From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Number of Participants Who Completely Discontinued Index Anticoagulant Treatment | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Time to Treatment Discontinuation | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Overall Index Anticoagulant Treatment Duration | From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months | Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months | Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. |
| Primary | Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption | Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Interruption in Index Anticoagulant Treatment | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, Number Analyzed signifies participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Treatment Interruption | From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Overall Number of Participants Analyzed: participants evaluable for this outcome measure with interruption event;Number Analyzed: participants evaluable for specified rows. | Days | MEDIAN |
| PRIMARY | Number of Participants Who Switched to Another Anticoagulant Therapy | From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, Number Analyzed signifies participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Treatment Switch | From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Overall Number of Participants Analyzed: participants evaluable for this outcome measure with switch event; Number Analyzed: participants evaluable for specified rows. | Days | MEDIAN |
| PRIMARY | Number of Participants Who Completely Discontinued Index Anticoagulant Treatment | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, Number Analyzed signifies participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Treatment Discontinuation | From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC,hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Overall Number of Participants Analyzed:participants evaluable for this outcome measure with discontinuation event;Number Analyzed:participants evaluable for specified rows. | Days | MEDIAN |
| PRIMARY | Overall Index Anticoagulant Treatment Duration | From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, Number Analyzed signifies participants evaluable for specified rows. | Days | MEDIAN |
| PRIMARY | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months | Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, Number Analyzed signifies participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months | Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as one entity, while individual NOAC results discriminated between each NOAC, therefore total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Here, Number Analyzed signifies participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption | Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study) | All eligible participants whose medical records were retrieved and observed in this study. 'NOAC-based therapy' arm considered all NOACs as 1 entity, while individual NOAC results discriminated between each NOAC, hence total number of participants with outcome in NOAC-based therapy is not equal to sum of individual NOACs. Overall Number of Participants Analyzed: participants evaluable for this outcome measure with interruption event;Number Analyzed: participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group750
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Interruption in Index Anticoagulant Treatment | Warfarin-Based Therapy | Without Active Cancer | 3429 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | NOAC-Based Therapy | Without Active Cancer | 8169 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | NOAC-Based Therapy: Apixaban | Without Active Cancer | 965 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | NOAC-Based Therapy: Dabigatran | Without Active Cancer | 492 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | NOAC-Based Therapy: Edoxaban | Without Active Cancer | 439 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | NOAC-Based Therapy: Rivaroxaban | Without Active Cancer | 5973 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | PAC Only | Without Active Cancer | 1226 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | Warfarin-Based Therapy | With Active Cancer | 172 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | NOAC-Based Therapy | With Active Cancer | 961 | Participants | |
| Number of Participants With Interruption in Index Anticoagulant Treatment | NOAC-Based Therapy: Apixaban | With Active Cancer | 115 | Participants |
1 to 10 of 750Source ClinicalTrials.gov
See all 750 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Warfarin-Based Therapy | 11,208 | |
| Overall Study | STARTED | Non-vitamin K Antagonist Oral Anticoagulants (NOAC)-Based Therapy: Apixaban | 5,047 | |
| Overall Study | STARTED | NOAC-Based Therapy: Dabigatran | 2,103 | |
| Overall Study | STARTED | NOAC-Based Therapy: Edoxaban | 2,342 | |
| Overall Study | STARTED | NOAC-Based Therapy: Rivaroxaban | 26,276 | |
| Overall Study | STARTED | Parenteral Anticoagulants (PAC) Only | 8,783 | |
| Overall Study | Without Active Cancer | Warfarin-Based Therapy | 10,390 | |
| Overall Study | Without Active Cancer | Non-vitamin K Antagonist Oral Anticoagulants (NOAC)-Based Therapy: Apixaban | 4,543 | |
| Overall Study | Without Active Cancer | NOAC-Based Therapy: Dabigatran | 1,894 | |
| Overall Study | Without Active Cancer | NOAC-Based Therapy: Edoxaban | 2,078 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Warfarin-Based Therapy | 0 | 0 |
| Total, all-cause mortality | NOAC-Based Therapy: Apixaban | 0 | 0 |
| Total, all-cause mortality | NOAC-Based Therapy: Dabigatran | 0 | 0 |
| Total, all-cause mortality | NOAC-Based Therapy: Edoxaban | 0 | 0 |
| Total, all-cause mortality | NOAC-Based Therapy: Rivaroxaban | 0 | 0 |
| Total, all-cause mortality | PAC Only | 0 | 0 |
| Total, other adverse events | Warfarin-Based Therapy | 0 | 0 |
| Total, other adverse events | NOAC-Based Therapy: Apixaban | 0 | 0 |
| Total, other adverse events | NOAC-Based Therapy: Dabigatran | 0 | 0 |
| Total, other adverse events | NOAC-Based Therapy: Edoxaban | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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