Trial · NCT00371683
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT00371683, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2015-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery. Trials, record NCT00371683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00371683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
- NCT number
- NCT00371683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,608 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Interventions
- Enoxaparin + Placebo, Apixaban + Placebo
- First posted
- 2006-09-04
- Last updated
- 2015-12-30
- Results first posted
- 2015-12-30
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization. |
| Primary | Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population | First dose of study drug to last dose, plus 2 days post last dose | ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days. |
| Primary | Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period | Last dose of study drug to Day 72 (60 days) | ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72. |
| Secondary | Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). |
| Secondary | Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). |
| Secondary | Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). |
| Secondary | Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). |
| Secondary | Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). |
| Secondary | Event Rate for Participants With All-Cause Death During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%). |
| Secondary | Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Primary Population=All randomized participants who: have an adjudicated and evaluable bilateral venogram performed during the Intended Treatment Period; or have an adjudicated VTE during the Intended Treatment Period; or die due to any cause during the Intended Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated non-fatal PE or death, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With All-Cause Death During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All Randomized participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All randomized participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All randomized participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period | From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization | All randomized participants were analyzed. | percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group178
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects | Apixaban 2.5mg BID | 8.99 | 95% Confidence Interval 7.47 to 10.79 | percentage of participants | |
| Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects | Enoxaparin 30 mg SC Injection q 12 Hours | 8.85 | 95% Confidence Interval 7.33 to 10.66 | percentage of participants | |
| Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period | Apixaban 2.5mg BID | 2.05 | 95% Confidence Interval 1.39 to 3.01 | percentage of participants | |
| Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period | Enoxaparin 30 mg SC Injection q 12 Hours | 1.64 | 95% Confidence Interval 1.06 to 2.55 | percentage of participants | |
| Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period | Apixaban 2.5mg BID | 8.91 | 95% Confidence Interval 7.40 to 10.71 | percentage of participants | |
| Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period | Enoxaparin 30 mg SC Injection q 12 Hours | 8.61 | 95% Confidence Interval 7.10 to 10.40 | percentage of participants | |
| Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period | Apixaban 2.5mg BID | 1.97 | 95% Confidence Interval 1.33 to 2.92 | percentage of participants | |
| Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period | Enoxaparin 30 mg SC Injection q 12 Hours | 1.40 | 95% Confidence Interval 0.86 to 2.26 | percentage of participants | |
| Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period | Apixaban 2.5mg BID | 2.13 | 95% Confidence Interval 1.46 to 3.10 | percentage of participants | |
| Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period | Enoxaparin 30 mg SC Injection q 12 Hours | 1.97 | 95% Confidence Interval 1.32 to 2.94 | percentage of participants |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Treatment Period-Randomized Patients | STARTED | Apixaban 2.5mg BID | 1,599 | |
| DB Treatment Period-Randomized Patients | STARTED | Enoxaparin 30 mg SC Injection q 12 Hours | 1,596 | |
| DB Treatment Period-Randomized Patients | COMPLETED | Apixaban 2.5mg BID | 1,509 | |
| DB Treatment Period-Randomized Patients | COMPLETED | Enoxaparin 30 mg SC Injection q 12 Hours | 1,489 | |
| DB Treatment Period-Randomized Patients | NOT COMPLETED | Apixaban 2.5mg BID | 90 | |
| DB Treatment Period-Randomized Patients | NOT COMPLETED | Enoxaparin 30 mg SC Injection q 12 Hours | 107 | |
| Follow-Up Period - Randomized Patients | STARTED | Apixaban 2.5mg BID | 1,553 | |
| Follow-Up Period - Randomized Patients | STARTED | Enoxaparin 30 mg SC Injection q 12 Hours | 1,533 | |
| Follow-Up Period - Randomized Patients | COMPLETED | Apixaban 2.5mg BID | 1,492 | |
| Follow-Up Period - Randomized Patients | COMPLETED | Enoxaparin 30 mg SC Injection q 12 Hours | 1,461 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events326
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 | Vomiting | Gastrointestinal disorders | Apixaban 2.5mg BID | 99 | 1,596 | |
| other | Vomiting | Gastrointestinal disorders | Enoxaparin 30 mg SC Injection q 12 Hours | 102 | 1,588 | |
| other | Insomnia | Psychiatric disorders | Apixaban 2.5mg BID | 77 | 1,596 | |
| other | Insomnia | Psychiatric disorders | Enoxaparin 30 mg SC Injection q 12 Hours | 86 | 1,588 | |
| other | Dizziness | Nervous system disorders | Apixaban 2.5mg BID | 103 | 1,596 | |
| other | Dizziness | Nervous system disorders | Enoxaparin 30 mg SC Injection q 12 Hours | 88 | 1,588 | |
| other | Deep vein thrombosis | Vascular disorders | Apixaban 2.5mg BID | 127 | 1,596 | |
| other | Deep vein thrombosis | Vascular disorders | Enoxaparin 30 mg SC Injection q 12 Hours | 113 | 1,588 | |
| other | Nausea | Gastrointestinal disorders | Apixaban 2.5mg BID | 208 | 1,596 | |
| other | Nausea | Gastrointestinal disorders | Enoxaparin 30 mg SC Injection q 12 Hours | 241 | 1,588 |
1 to 10 of 326Source ClinicalTrials.gov
See all 326 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apixaban 2.5mg BID | ||
| Total, all-cause mortality | Enoxaparin 30 mg SC Injection q 12 Hours | ||
| Total, other adverse events | Apixaban 2.5mg BID | 713 | 1,596 |
| Total, other adverse events | Enoxaparin 30 mg SC Injection q 12 Hours | 741 | 1,588 |
| Total, serious adverse events | Apixaban 2.5mg BID | 123 | 1,596 |
| Total, serious adverse events | Enoxaparin 30 mg SC Injection q 12 Hours | 123 | 1,588 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Apixaban 2.5mg BID vs Enoxaparin 30 mg SC Injection q 12 Hours: serious adverse events |
Source 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/NCT00371683
GET https://conductscience.org/api/trials/v1/NCT00371683/registered?page=2