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NCT00580216 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

A Phase 3 study, sponsored by Sanofi.

Terminated
Registry status
Phase 3
Development phase
3,773
Enrollment target

NCT00580216: Clinical Trial Phase 3 study, sponsored by Sanofi.

NCT00580216 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 3,773 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (389% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00580216, a Phase 3 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 3
Development phase
3,773 participants
Enrollment target

Study Summary

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

Interventions

  • DRUG Warfarin
  • DRUG Idrabiotaparinux sodium
  • DRUG Avidin
  • DRUG Placebo (for warfarin)
  • DRUG Placebo (for idrabiotaparinux)

Trial Details

FieldValue
Enrollment Target 3,773 participants
Start Date 2007-12
Est. Completion 2010-10
Phase Phase 3
Sanofi

713 total trials

Why NCT00580216 stopped before completion

NCT00580216 is an interventional study that assigns participants to a tested intervention. Its 3,773 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (389% higher).

The record links to 0 conditions, and to 5 interventions - of which Warfarin is the first listed.

NCT00580216 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00580216 about?

NCT00580216 is a clinical study titled "Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation". The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial ...

What is the current status of trial NCT00580216?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3,773 participants. The study started on 2007-12. Estimated completion is 2010-10.

What interventions are being tested in trial NCT00580216?

The interventions under investigation include: Warfarin (DRUG), Idrabiotaparinux sodium (DRUG), Avidin (DRUG), Placebo (for warfarin) (DRUG), Placebo (for idrabiotaparinux) (DRUG).

Who is sponsoring clinical trial NCT00580216?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00580216's enrollment target sits among peer trials

3,773 66th of 2000 higher than 1,935 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00580216, the US trial registry maintained by the National Library of Medicine. NCT00580216 (large enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.