Trial · NCT00643201
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
NCT00643201, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2014-04-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism. Trials, record NCT00643201. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00643201
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
- NCT number
- NCT00643201
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,614 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Venous Thrombosis
- Interventions
- Enoxaparin, warfarin, Placebo for apixaban, Placebo for enoxaparin, Placebo for warfarin, apixaban
- First posted
- 2008-03-26
- Last updated
- 2014-04-21
- Other registries' IDs
- eudract:2007-007867-25
- Results first posted
- 2014-04-10
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment | Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early) | VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat). |
| Secondary | Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded. |
| Secondary | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite. |
| Secondary | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle |
| Secondary | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis \>5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT). |
| Secondary | Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). |
| Secondary | Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period | Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early) | PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). |
| Secondary | Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle). |
| Secondary | Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle). |
| Secondary | Incidence of All-Cause Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment | Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early) | All randomized participants with a non-missing primary endpoint (n/N: 59/2609; 71/2635, in apixaban, enoxaparin/warfarin, respectively). Intent-to-treat population. Confidence interval (CI) for event rate calculated based on the Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | All randomized participants with non-missing secondary endpoint (n/N: 84/2609; 104/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | All randomized participants with non-missing secondary endpoint (n/N: 61/2609; 77/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | Total number of participants in each randomized arm, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 73/2610; 118/2635). Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | Total number participants in each treatment group, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 183/2617; 333/2641). Events included as per ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period | Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early) | Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 22/2608; 35/2633). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period | Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early) | Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 27/2606; 25/2632). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants in respective treatment groups excluding participants with missing endpoint information. (n/N: 12/2608; 16/2630). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants in respective groups excluding those with missing endpoint information (n/N: 15/2608; 23/2630). CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
| SECONDARY | Incidence of All-Cause Death During the Intended Treatment Period | Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early) | Total number of participants excluding those with missing endpoint (n/N: 41/2608; 52/2630). Events included regardless of whether or not participant received treatment, ie, ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits. | proportion of participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment | Apixaban | 0.0226 | 95% Confidence Interval 0.0169 to 0.0283 | proportion of participants | |
| Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment | Enoxaparin + Warfarin | 0.0269 | 95% Confidence Interval 0.0208 to 0.0331 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death | Apixaban | 0.0322 | 95% Confidence Interval 0.0254 to 0.0390 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death | Enoxaparin + Warfarin | 0.0395 | 95% Confidence Interval 0.0320 to 0.0469 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death | Apixaban | 0.0234 | 95% Confidence Interval 0.0176 to 0.0292 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death | Enoxaparin + Warfarin | 0.0292 | 95% Confidence Interval 0.0228 to 0.0357 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding | Apixaban | 0.0280 | 95% Confidence Interval 0.0216 to 0.0343 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding | Enoxaparin + Warfarin | 0.0448 | 95% Confidence Interval 0.0369 to 0.0527 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding | Apixaban | 0.0699 | 95% Confidence Interval 0.0602 to 0.0797 | proportion of participants | |
| Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding | Enoxaparin + Warfarin | 0.1261 | 95% Confidence Interval 0.1134 to 0.1387 | proportion of participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized, Completed 6 Months of Study | STARTED | Apixaban | 2,691 | |
| Randomized, Completed 6 Months of Study | STARTED | Enoxaparin + Warfarin | 2,704 | |
| Randomized, Completed 6 Months of Study | COMPLETED | Apixaban | 2,314 | |
| Randomized, Completed 6 Months of Study | COMPLETED | Enoxaparin + Warfarin | 2,291 | |
| Randomized, Completed 6 Months of Study | NOT COMPLETED | Apixaban | 377 | |
| Randomized, Completed 6 Months of Study | NOT COMPLETED | Enoxaparin + Warfarin | 413 | |
| Completed Study Follow Up | STARTED | Apixaban | 2,617 | |
| Completed Study Follow Up | STARTED | Enoxaparin + Warfarin | 2,639 | |
| Completed Study Follow Up | COMPLETED | Apixaban | 2,547 | |
| Completed Study Follow Up | COMPLETED | Enoxaparin + Warfarin | 2,560 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,020
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 | Apixaban | 73 | 2,676 | |
| other | CONSTIPATION | Gastrointestinal disorders | Enoxaparin/Warfarin | 87 | 2,689 | |
| other | DIARRHOEA | Gastrointestinal disorders | Apixaban | 100 | 2,676 | |
| other | DIARRHOEA | Gastrointestinal disorders | Enoxaparin/Warfarin | 106 | 2,689 | |
| other | NAUSEA | Gastrointestinal disorders | Apixaban | 81 | 2,676 | |
| other | NAUSEA | Gastrointestinal disorders | Enoxaparin/Warfarin | 106 | 2,689 | |
| other | VOMITING | Gastrointestinal disorders | Apixaban | 50 | 2,676 | |
| other | VOMITING | Gastrointestinal disorders | Enoxaparin/Warfarin | 69 | 2,689 | |
| other | FATIGUE | General disorders | Apixaban | 58 | 2,676 | |
| other | FATIGUE | General disorders | Enoxaparin/Warfarin | 50 | 2,689 |
1 to 10 of 1,020Source ClinicalTrials.gov
See all 1,020 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 | Enoxaparin/Warfarin | ||
| Total, other adverse events | Apixaban | 1,014 | 2,676 |
| Total, other adverse events | Enoxaparin/Warfarin | 1,207 | 2,689 |
| Total, serious adverse events | Apixaban | 417 | 2,676 |
| Total, serious adverse events | Enoxaparin/Warfarin | 410 | 2,689 |
Source ClinicalTrials.gov
Papers5
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 vs Enoxaparin/Warfarin: 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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GET https://conductscience.org/api/trials/v1/NCT00643201
GET https://conductscience.org/api/trials/v1/NCT00643201/registered?page=2