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Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
NCT01583218 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.
Conditions Studied
Interventions
- DRUG Enoxaparin
- DRUG Betrixaban
Study Locations (20)
California
- — Bakersfield
- — Fresno
- — La Mesa
- — Long Beach
- — Los Angeles
- — Modesto
- — San Diego
- — Stanford
- — Torrance
Florida
- — Bay Pines
- — Clearwater
- — Jacksonville
- — Miami
- — Pensacola
- — Sarasota
- — Vero Beach
Georgia
- — Columbus
- — Decatur
Alabama
- — Birmingham
Colorado
- — Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,513 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01583218
The ClinicalTrials.gov registry entry for NCT01583218 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 7,513 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Portola Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Venous Thromboembolism (VTE) appearing as the primary indexed condition, and to 2 interventions — of which Enoxaparin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01583218 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01583218 about?
NCT01583218 is a clinical study titled "Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)". The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban wil...
What is the current status of trial NCT01583218?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,513 participants. The study started on 2012-03. Estimated completion is 2016-01.
What conditions does trial NCT01583218 study?
This clinical trial studies the following conditions: Venous Thromboembolism (VTE). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01583218?
The interventions under investigation include: Enoxaparin (DRUG), Betrixaban (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01583218?
This trial is sponsored by Portola Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01583218 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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