Deep Vein ThrombosisPhase 3NCT01780987
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
A Phase 3 study testing Apixaban, Unfractionated Heparin (UFH) and Warfarin in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Pfizer at 20 sites in Japan.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- Apixaban, Unfractionated Heparin (UFH) and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 20 sitesJapan
- Study dates
- Jan 2013to Sep 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute symptomatic proximal DVT with evidence of proximal thrombosis
- Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches
Who cannot join
- Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
- Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
- Subjects requiring dual anti-platelet therapy
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Hiroshima General Hospital
Hatsukaichi, Hiroshima, 738-8503
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, 920-0293
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
Japanese Red Cross Musashino Hospital
Musashino, Tokyo, 180-8610
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741
Teine Keijinkai Hospital
Sapporo, Hokkaido, 006-8555
Kinki University Hospital
Sayama, Osaka, 589-8511
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka, 565-8565
Nihon University Itabashi Hospital
tabashi City, Tokyo, 173-8610
Mie University Hospital
Tsu, Mie-ken, 514-8507
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa, 236-0037
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, 245-8575
About this study
Official title: Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese
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)
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- DVT, PE, VTE
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
Unfractionated Heparin (UFH)Drug
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
WarfarinDrug
Dosing for 24 weeks to target INR range between 1.5-2.5
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Not described Receives: Drug: Apixaban |
| UFH/Warfarin | Active comparator | Not described Receives: Drug: Unfractionated Heparin (UFH); Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 24
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780987
- Sponsor's protocol ID
- B0661024
- Other IDs
- CV185160
- Status last verified
- May 2016
- First submitted
- 29 Jan 2013
- Last updated
- 23 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese
- ClinicalTrials.gov ID
- NCT01780987
- Acronym / sponsor ID
- B0661024
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- DVT, PE, VTE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 23 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Apixaban |
| UFH/Warfarin | Active comparator | Drug: Unfractionated Heparin (UFH), Drug: Warfarin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute symptomatic proximal DVT with evidence of proximal thrombosis
- Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches
Key exclusion criteria (3 listed)
- Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
- Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
- Subjects requiring dual anti-platelet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks) | Drug | Apixaban |
| Unfractionated Heparin (UFH)Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more | Drug | UFH/Warfarin |
| WarfarinDosing for 24 weeks to target INR range between 1.5-2.5 | Drug | UFH/Warfarin |
Primary outcome
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
Time frame: 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.
5 secondary outcomes
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
Time frame: Baseline to Week 24
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
Time frame: Baseline to Week 24
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
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
Time frame: Baseline to Week 24
Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban, Unfractionated Heparin (UFH) and Warfarin in people with Deep Vein Thrombosis and Pulmonary Embolism, run by Pfizer at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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 (time frame: Baseline to Week 24). 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 23 Jun 2016.