Trial · NCT01780987
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
NCT01780987, Phase 3, Completed, Pfizer; results first posted 2016-06-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients. Trials, record NCT01780987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01780987
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
- NCT number
- NCT01780987
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 80 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Interventions
- Apixaban, Unfractionated Heparin (UFH), Warfarin
- First posted
- 2013-01-31
- Last updated
- 2016-06-23
- Results first posted
- 2016-06-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period | Baseline to Week 24 | Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. |
| Secondary | Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period | Baseline to Week 24 | VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. "Intended Treatment Period" was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late. |
| Secondary | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Baseline to Week 24 | Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24. |
| Secondary | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) | Baseline to Week 24 | Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24. |
| Secondary | Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period | Baseline to Week 24 | Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. |
| Secondary | Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods | Baseline to Week 24 | All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding. |
Source ClinicalTrials.gov
Outcomes6
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 Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period | Baseline to Week 24 | The safety analysis set (SAS) consisted of all treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period | Baseline to Week 24 | Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Baseline to Week 24 | A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated. | participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) | Baseline to Week 24 | A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated. | participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period | Baseline to Week 24 | The safety analysis set (SAS) consisted of all treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods | Baseline to Week 24 | The safety analysis set (SAS) consisted of all treated participants. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
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 Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period | Apixaban | 3 | participants | ||
Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period | Unfractionated Heparin (UFH)/Warfarin | 11 | participants | ||
Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period | Apixaban | 0 | participants | ||
Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period | Unfractionated Heparin (UFH)/Warfarin | 1 | participants | ||
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Apixaban | CUS - Week 2 (n=22, n=22) | 1 | participants | |
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Unfractionated Heparin (UFH)/Warfarin | CUS - Week 2 (n=22, n=22) | 2 | participants | |
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Apixaban | CTV - Week 12 (n=20, n=21) | 0 | participants | |
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Unfractionated Heparin (UFH)/Warfarin | CTV - Week 12 (n=20, n=21) | 0 | participants | |
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Apixaban | CUS - Week 12 (n=21, n=22) | 0 | participants | |
| Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) | Unfractionated Heparin (UFH)/Warfarin | CUS - Week 12 (n=21, n=22) | 0 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apixaban | 40 | |
| Overall Study | STARTED | Unfractionated Heparin (UFH)/Warfarin | 40 | |
| Overall Study | COMPLETED | Apixaban | 37 | |
| Overall Study | COMPLETED | Unfractionated Heparin (UFH)/Warfarin | 34 | |
| Overall Study | NOT COMPLETED | Apixaban | 3 | |
| Overall Study | NOT COMPLETED | Unfractionated Heparin (UFH)/Warfarin | 6 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Apixaban | 0 | 40 | |
| other | Atrial fibrillation | Cardiac disorders | Unfractionated Heparin (UFH)/Warfarin | 2 | 39 | |
| other | Palpitations | Cardiac disorders | Apixaban | 2 | 40 | |
| other | Palpitations | Cardiac disorders | Unfractionated Heparin (UFH)/Warfarin | 2 | 39 | |
| other | Constipation | Gastrointestinal disorders | Apixaban | 5 | 40 | |
| other | Constipation | Gastrointestinal disorders | Unfractionated Heparin (UFH)/Warfarin | 8 | 39 | |
| other | Diarrhoea | Gastrointestinal disorders | Apixaban | 3 | 40 | |
| other | Diarrhoea | Gastrointestinal disorders | Unfractionated Heparin (UFH)/Warfarin | 1 | 39 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Apixaban | 0 | 40 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Unfractionated Heparin (UFH)/Warfarin | 2 | 39 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apixaban | ||
| Total, all-cause mortality | Unfractionated Heparin (UFH)/Warfarin | ||
| Total, other adverse events | Apixaban | 29 | 40 |
| Total, other adverse events | Unfractionated Heparin (UFH)/Warfarin | 34 | 39 |
| Total, serious adverse events | Apixaban | 3 | 40 |
| Total, serious adverse events | Unfractionated Heparin (UFH)/Warfarin | 7 | 39 |
Source ClinicalTrials.gov
Papers0
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Apixaban vs Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period | Trial comparisons |
Apixaban vs Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period | Trial comparisons |
Apixaban vs Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period | Trial comparisons |
| Apixaban vs Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods | Trial comparisons |
| Apixaban vs Unfractionated Heparin (UFH)/Warfarin: serious adverse events | Trial comparisons |
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.
GET https://conductscience.org/api/trials/v1/NCT01780987
GET https://conductscience.org/api/trials/v1/NCT01780987/results?page=2