Trial · NCT01499953
Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
NCT01499953, Phase 3, Completed, GWT-TUD GmbH; results first posted 2023-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux. Trials, record NCT01499953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01499953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
- NCT number
- NCT01499953
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 472 participants, actual
- Lead sponsor
- GWT-TUD GmbH
- Conditions
- Superficial Vein Thrombosis
- Interventions
- Rivaroxaban, Fondaparinux
- First posted
- 2011-12-26
- Last updated
- 2023-05-15
- Results first posted
- 2023-05-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Objectively Confirmed VTE Complications | 45 +/- 5 days | The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism (confirmed by ventilation-perfusion scanning, helical computed tomography, pulmonary angiography, or autopsy), symptomatic deep vein thrombosis (confirmed by ultrasonography or venography), or symptomatic extension towards the saphenofemoral junction or symptomatic recurrence of superficial vein thrombosis (confirmed by ultrasonography) up to day 45. |
| Secondary | Composite Primary Efficacy Outcome | 90 +/- 10 days | For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT. |
| Secondary | Rate of Major VTE | 90 +/-10 days | composite of: * symptomatic pulmonary embolism * symptomatic proximal DVT * VTE-related death |
| Secondary | Rates of Surgery for SVT | 90 +/-10 days | |
| Other | Major Bleeding (Main Safety Outcome) | 45 +/- 5 days | * associated with a fall of hemoglobin of 2 g/l or more, or; * leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or; * occurring into a critical site such as intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or; * fatal bleeding. |
| Other | Clinically Relevant Non-major, Minor and Total (Any) Bleeding | 45 +/- 5 days | Clinically relevant, non-major bleeding is defined as any overt bleeding and * associated with a medical intervention, or * unscheduled contact with the physician (presence or telephone contact) * temporary or complete cessation of study drug * associated with any relevant discomfort to the patient (pain, impairment of activities of daily life) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Objectively Confirmed VTE Complications | 45 +/- 5 days | Per protocol set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite Primary Efficacy Outcome | 90 +/- 10 days | Per protocol analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Major VTE | 90 +/-10 days | Per protocol set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rates of Surgery for SVT | 90 +/-10 days | Per protocol set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Major Bleeding (Main Safety Outcome) | 45 +/- 5 days | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Clinically Relevant Non-major, Minor and Total (Any) Bleeding | 45 +/- 5 days | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Objectively Confirmed VTE Complications | Rivaroxaban | 7 | Participants | ||
| Rate of Objectively Confirmed VTE Complications | Fondaparinux | 4 | Participants | ||
| Composite Primary Efficacy Outcome | Rivaroxaban | 15 | Participants | ||
| Composite Primary Efficacy Outcome | Fondaparinux | 15 | Participants | ||
| Rate of Major VTE | Rivaroxaban | Deep vein thrombosis | 6 | Participants | |
| Rate of Major VTE | Fondaparinux | Deep vein thrombosis | 2 | Participants | |
| Rate of Major VTE | Rivaroxaban | Pulmonary embolism | 0 | Participants | |
| Rate of Major VTE | Fondaparinux | Pulmonary embolism | 0 | Participants | |
| Rate of Major VTE | Rivaroxaban | VTE-related death | 0 | Participants | |
| Rate of Major VTE | Fondaparinux | VTE-related death | 0 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fondaparinux | 236 | |
| Overall Study | STARTED | Rivaroxaban | 236 | |
| Overall Study | Participants Who Received at Least One Dose of Study Medication | Fondaparinux | 235 | |
| Overall Study | Participants Who Received at Least One Dose of Study Medication | Rivaroxaban | 236 | |
| Overall Study | COMPLETED | Fondaparinux | 226 | |
| Overall Study | COMPLETED | Rivaroxaban | 222 | |
| Overall Study | NOT COMPLETED | Fondaparinux | 10 | |
| Overall Study | NOT COMPLETED | Rivaroxaban | 14 |
Source ClinicalTrials.gov
Adverse events22
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 |
|---|---|---|---|---|---|---|
| serious | Suspected infection-associated seizure | Infections and infestations | Fondaparinux | 0 | 235 | 0 |
| serious | Suspected infection-associated seizure | Infections and infestations | Rivaroxaban | 1 | 236 | 1 |
| serious | Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Fondaparinux | 0 | 235 | 0 |
| serious | Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Rivaroxaban | 1 | 236 | 1 |
| serious | Mucosal bleeding | General disorders | Fondaparinux | 0 | 235 | 0 |
| serious | Mucosal bleeding | General disorders | Rivaroxaban | 1 | 236 | 1 |
| serious | New onset of atrial fibrillation | Cardiac disorders | Fondaparinux | 0 | 235 | 0 |
| serious | New onset of atrial fibrillation | Cardiac disorders | Rivaroxaban | 1 | 236 | 1 |
| serious | Worsening of arterial hypertension | Vascular disorders | Fondaparinux | 0 | 235 | 0 |
| serious | Worsening of arterial hypertension | Vascular disorders | Rivaroxaban | 1 | 236 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fondaparinux | 0 | 235 |
| Total, all-cause mortality | Rivaroxaban | 1 | 236 |
| Total, other adverse events | Fondaparinux | 0 | 235 |
| Total, other adverse events | Rivaroxaban | 0 | 236 |
| Total, serious adverse events | Fondaparinux | 3 | 235 |
| Total, serious adverse events | Rivaroxaban | 7 | 236 |
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rivaroxaban vs Fondaparinux: Major Bleeding (Main Safety Outcome) | Trial comparisons |
| Rivaroxaban vs Fondaparinux: Rate of Objectively Confirmed VTE Complications | Trial comparisons |
| Rivaroxaban vs Fondaparinux: Rates of Surgery for SVT | Trial comparisons |
| Fondaparinux vs Rivaroxaban: deaths from any cause | Trial comparisons |
| Rivaroxaban vs Fondaparinux: Composite Primary Efficacy Outcome | Trial comparisons |
| Fondaparinux vs Rivaroxaban: serious adverse events | 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/NCT01499953
GET https://conductscience.org/api/trials/v1/NCT01499953/events?page=2