A Phase 3 interventional study of Apixaban and Unfractionated Heparin (UFH) in Deep Vein Thrombosis and Pulmonary Embolism, sponsored by Pfizer. Completed at 20 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-06-23.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)
787 studies on the registry are indexed under Venous Thrombosis; 123 are open to participants now.
This study's enrollment of 80 is below the median of 131 across 463 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Exclusion Criteria:
Drug: Apixaban
Drug: Unfractionated Heparin (UFH) · Drug: 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
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.
Time frame: Baseline to Week 24
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
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.
Time frame: Baseline to Week 24
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
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.
Time frame: Baseline to Week 24
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
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.
Time frame: Baseline to Week 24
Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period
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.
Time frame: Baseline to Week 24
Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
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.
Time frame: Baseline to Week 24
| Milestone | Apixaban | Unfractionated Heparin (UFH)/Warfarin |
|---|---|---|
| Started | 40 | 40 |
| Completed | 37 | 34 |
| Not completed | 3 | 6 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Request of changing hospital | 0 | 1 |
| Withdrew: Changing residence | 1 | 0 |
| Withdrew: Not receiving any study medication | 0 | 1 |
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.
| participants | Apixaban | 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 | 3 | 11 |
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.
| participants | Apixaban | 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 | 0 | 1 |
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.
| participants | Apixaban | Unfractionated Heparin (UFH)/Warfarin |
|---|---|---|
| CUS - Week 2 (n=22, n=22) | 1 | 2 |
| CTV - Week 12 (n=20, n=21) | 0 | 0 |
| CUS - Week 12 (n=21, n=22) | 0 | 0 |
| CUS - Week 24 (n=20, n=22) | 0 | 1 |
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.
| participants | Apixaban | Unfractionated Heparin (UFH)/Warfarin |
|---|---|---|
| CTPA - Week 2 (n=18, n=17) | 0 | 0 |
| CTPA - Week 12 (n=18, n=16) | 0 | 0 |
| CTPA - Week 24 (n=16, n=15) | 0 | 1 |
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.
| participants | Apixaban | 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 | 0 | 2 |
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.
| participants | Apixaban | Unfractionated Heparin (UFH)/Warfarin |
|---|---|---|
| Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods | 7 | 17 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apixaban | — | 3/40 (7.5%) | 29/40 (72.5%) |
| Unfractionated Heparin (UFH)/Warfarin | — | 7/39 (17.9%) | 34/39 (87.2%) |
| Event | Apixaban | Unfractionated Heparin (UFH)/Warfarin |
|---|---|---|
| Angina unstableCardiac disorders | 0/40 | 1/39 |
| CystitisInfections and infestations | 0/40 | 1/39 |
| PneumoniaInfections and infestations | 0/40 | 1/39 |
| Decreased appetiteMetabolism and nutrition disorders | 0/4 | 1/39 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/40 | 1/39 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/40 | 1/39 |
| Thalamus haemorrhageNervous system disorders | 0/40 | 1/39 |
| MenorrhagiaReproductive system and breast disorders | 0/40 | 1/39 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/40 | 1/39 |
| Deep vein thrombosisVascular disorders | 0/40 | 1/39 |
| Event | Apixaban | Unfractionated Heparin (UFH)/Warfarin |
|---|---|---|
| ConstipationGastrointestinal disorders | 5/40 | 8/39 |
| PyrexiaGeneral disorders | 4/40 | 5/39 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 3/40 | 5/39 |
| NasopharyngitisInfections and infestations | 5/40 | 4/39 |
| CystitisInfections and infestations | 1/40 | 4/39 |
| ContusionInjury, poisoning and procedural complications | 2/40 | 4/39 |
| FallInjury, poisoning and procedural complications | 4/40 | 4/39 |
| InsomniaPsychiatric disorders | 4/40 | 4/39 |
| Haemorrhage subcutaneousSkin and subcutaneous tissue disorders | 1/40 | 4/39 |
| NauseaGastrointestinal disorders | 1/40 | 3/39 |
All participants including one participant who was assigned to the UFH/Warfarin group and withdrew from the study prior to receiving any study medication.
| Age, Continuous(years) | Apixaban | Unfractionated Heparin (UFH)/Warfarin | Total |
|---|---|---|---|
| Mean | 64.3 ± 13.40 | 66.1 ± 17.72 | 65.2 ± 15.64 |
| Sex: Female, Male(Participants) | Apixaban | Unfractionated Heparin (UFH)/Warfarin | Total |
|---|---|---|---|
| Female | 18 | 23 | 41 |
| Male | 22 | 17 | 39 |
| Primary Diagnosis, Deep Venous Thrombosis (DVT)/Pulmonary Embolism (PE)(participants) | Apixaban | Unfractionated Heparin (UFH)/Warfarin | Total |
|---|---|---|---|
| DVT | 22 | 23 | 45 |
| PE | 18 | 17 | 35 |
The record gives a start of Jan 2013, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2016, 1 year 9 months after primary completion.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apixaban