Trial · NCT00452530
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT00452530, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2014-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery. Trials, record NCT00452530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00452530
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
- NCT number
- NCT00452530
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,221 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Interventions
- Enoxaparin, Apixaban, Enoxaparin-matching placebo, Apixaban-matching placebo
- First posted
- 2007-03-27
- Last updated
- 2014-07-09
- Other registries' IDs
- eudract:2006-006896-19
- Results first posted
- 2014-05-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period | Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug | Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. |
| Secondary | Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period | Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study | Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause. |
| Secondary | Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Days 1 to 12 | Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment. |
| Secondary | Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome | Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Bleeding AEs=all serious or nonserious bleeding-related AEs. |
| Other | Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements) | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up | preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): \>2 decrease from preRx value or value \<=8; hematocrit (%): \<0.75\*preRx; platelets: \<100\*10\^9 cells/L; erythrocytes (\*10\^6 cells/μL): \<0.75\*preRx; leukocytes: \<0.75\*LLN or \>1.25\*ULN, or if preRx \<LLN, use \<0.8\*preRx or \>ULN if preRx \>ULN use \>1.2\*preRx or \<LLN; abs basophils: \>400/mm\^3; abs eosinophils: \> 0.750\*10\^3 cells/µL; abs lymphocytes: \<0.750\*10\*3 cells/ µL or \>7.50\*10\^3 c/ µL; abs monocytes \> 2000/mm\^3; abs neutrophils: \<1.0\*10\^3 cells/μL; ALP (U/L): \>2\*ULN; ALT, AST (U/L): \>3\*ULN; U/L; bilirubin, direct (mg/dL): \>1.5\*ULN; bilirubin, total (mg/dL): \>2\*ULN; BUN (mg/dL): \>2\*ULN; creatinine (mg/dL): \>1.5\*ULN. |
| Other | Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements) | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up | preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): \<0.8\*LLN or \>1.2\*ULN, or if preRx\<LLN use \<0.75\*preRx or \>ULN if preRx \>ULN use \>1.25\*preRx or \<LLN; chloride, serum (mEq/L): \<0.9\*LLN or \>1.1\*ULN, or if preRx\<LLN use \<0.9\*preRx or \>ULN if preRx\>ULN use \>1.1\*preRx or \<LLN; bicarbonate (mEq/L): \<0.75\*LLN or \>1.25\*ULN, or if preRx \< LLN use \<0.75\*preRx or \>ULN if preRx \>ULN use \>1.25\*preRx or \< LLN; potassium, serum (mEq/L): \<0.9\* LLN or \>1.1\*ULN, or if preRx\<LLN use \<0.9 \*preRx or \>ULN if preRx\>ULN use \>1.1\*preRx or \<LLN; sodium, serum (mEq/L): \<0.95\*LLN or \>1.05\*ULN, or if preRx \<LLN use \<0.95\*preRx or \>ULN if preRx\>ULN use \>1.05\*preRx or \<LLN; protein, total (g/dL): \<0.9\*LLN or \>1.1\*ULN, or if preRx \<LLN use 0.9\*preRx or \>ULN if preRx \>ULN use 1.1\*preRx or \<LLN; CK (U/L): \>5\*ULN; uric acid (mg/dL): \>1.5\*ULN, or if preRx \>ULN use \>2\*preRx; glucose, fasting serum (mg/dL): \<0.8\*LLN or \>1.5\*ULN, or if preRx \<LLN use \<0.8\*preRx or \>ULN. |
| Other | Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis) | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up | preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period | Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study | Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period | Percentage of events/patients evaluated | NUMBER |
| SECONDARY | Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Days 1 to 12 | All participants who received at least 1 dose of study drug | Percentage of events/patients evaluated | NUMBER |
| PRIMARY | Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period | Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug | The primary efficacy data set (all randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, an adjudicated venous thrombolytic event; or died due to any cause.) | Percentage of events/patients evaluated | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome | Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug | All participants who received at least 1 dose of study drug | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements) | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up | All participants who received at least 1 dose of study drug. n=number of participants with available measurements | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements) | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up | All participants who received at least 1 dose of study drug. n=number of participants with available measurements | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis) | Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up | All participants who received at least 1 dose of study drug. n=number of participants with available measurements | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period | Apixaban, 2.5 mg BID + Placebo | 1.09 | 95% Confidence Interval 0.62 to 1.88 | Percentage of events/patients evaluated | |
| Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period | Enoxaparin, 40 mg QD + Placebo | 2.17 | 95% Confidence Interval 1.47 to 3.18 | Percentage of events/patients evaluated | |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Apixaban, 2.5 mg BID + Placebo | Major bleeding (n=9, 14) | 0.60 | 95% Confidence Interval 0.30 to 1.16 | Percentage of events/patients evaluated |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Enoxaparin, 40 mg QD + Placebo | Major bleeding (n=9, 14) | 0.93 | 95% Confidence Interval 0.54 to 1.57 | Percentage of events/patients evaluated |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Apixaban, 2.5 mg BID + Placebo | CRNM (n=44, 58) | 2.93 | 95% Confidence Interval 2.19 to 3.93 | Percentage of events/patients evaluated |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Enoxaparin, 40 mg QD + Placebo | CRNM (n=44, 58) | 3.85 | 95% Confidence Interval 2.98 to 4.95 | Percentage of events/patients evaluated |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Apixaban, 2.5 mg BID + Placebo | Major bleeding or CRNM (n=53, 72) | 3.53 | 95% Confidence Interval 2.71 to 4.60 | Percentage of events/patients evaluated |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Enoxaparin, 40 mg QD + Placebo | Major bleeding or CRNM (n=53, 72) | 4.77 | 95% Confidence Interval 3.81 to 5.98 | Percentage of events/patients evaluated |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Apixaban, 2.5 mg BID + Placebo | Any bleeding | 6.93 | 95% Confidence Interval 5.75 to 8.34 | Percentage of events/patients evaluated |
| Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM | Enoxaparin, 40 mg QD + Placebo | Any bleeding | 8.36 | 95% Confidence Interval 7.06 to 9.87 | Percentage of events/patients evaluated |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apixaban, 2.5 mg BID + Placebo | 1,528 | |
| Overall Study | STARTED | Enoxaparin, 40 mg QD + Placebo | 1,529 | |
| Overall Study | Received Treatment | Apixaban, 2.5 mg BID + Placebo | 1,501 | |
| Overall Study | Received Treatment | Enoxaparin, 40 mg QD + Placebo | 1,508 | |
| Overall Study | Evaluable Participants | Apixaban, 2.5 mg BID + Placebo | 907 | |
| Overall Study | Evaluable Participants | Enoxaparin, 40 mg QD + Placebo | 921 | |
| Overall Study | Primary Participants | Apixaban, 2.5 mg BID + Placebo | 976 | |
| Overall Study | Primary Participants | Enoxaparin, 40 mg QD + Placebo | 997 | |
| Overall Study | COMPLETED | Apixaban, 2.5 mg BID + Placebo | 1,392 | |
| Overall Study | COMPLETED | Enoxaparin, 40 mg QD + Placebo | 1,393 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events222
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 | Constipation | Gastrointestinal disorders | Apixiban, 2.5 mg BID Plus Placebo | 73 | 1,501 | |
| other | Constipation | Gastrointestinal disorders | Enoxaparin, 40 mg QD Plus Placebo | 77 | 1,508 | |
| other | Vomiting | Gastrointestinal disorders | Apixiban, 2.5 mg BID Plus Placebo | 77 | 1,501 | |
| other | Vomiting | Gastrointestinal disorders | Enoxaparin, 40 mg QD Plus Placebo | 88 | 1,508 | |
| other | Nausea | Gastrointestinal disorders | Apixiban, 2.5 mg BID Plus Placebo | 102 | 1,501 | |
| other | Nausea | Gastrointestinal disorders | Enoxaparin, 40 mg QD Plus Placebo | 120 | 1,508 | |
| other | Deep vein thrombosis | Vascular disorders | Apixiban, 2.5 mg BID Plus Placebo | 92 | 1,501 | |
| other | Deep vein thrombosis | Vascular disorders | Enoxaparin, 40 mg QD Plus Placebo | 130 | 1,508 | |
| serious | Creatinine renal clearance decreased | Investigations | Apixiban, 2.5 mg BID Plus Placebo | 0 | 1,501 | |
| serious | Creatinine renal clearance decreased | Investigations | Enoxaparin, 40 mg QD Plus Placebo | 1 | 1,508 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apixiban, 2.5 mg BID Plus Placebo | ||
| Total, all-cause mortality | Enoxaparin, 40 mg QD Plus Placebo | ||
| Total, other adverse events | Apixiban, 2.5 mg BID Plus Placebo | 295 | 1,501 |
| Total, other adverse events | Enoxaparin, 40 mg QD Plus Placebo | 342 | 1,508 |
| Total, serious adverse events | Apixiban, 2.5 mg BID Plus Placebo | 72 | 1,501 |
| Total, serious adverse events | Enoxaparin, 40 mg QD Plus Placebo | 88 | 1,508 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| Apixiban, 2.5 mg BID Plus Placebo vs Enoxaparin, 40 mg QD Plus Placebo: 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/NCT00452530
GET https://conductscience.org/api/trials/v1/NCT00452530/results?page=2