ClinicalTrials.gov record
Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT00580216
Public ClinicalTrials.gov record NCT00580216. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00580216
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,773 participants
Conditions and interventions
Conditions
Interventions
- Idrabiotaparinux sodium Drug
- Warfarin Drug
- Placebo (for idrabiotaparinux) Drug
- Placebo (for warfarin) Drug
- Avidin Drug
- Placebo (for avidin) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2007 (Type not available)
- Primary completion
- Oct 2010 (Actual)
- Completion
- Oct 2010 (Actual)
- Last update posted
- Mar 21, 2016
2007 – 2010
United States locations
- U.S. sites
- 162
- U.S. states
- 39
- U.S. cities
- 137
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 840227 | Mobile | Alabama | 36608 | — |
| Sanofi-Aventis Investigational Site Number 840209 | Tucson | Arizona | 85723 | — |
| Sanofi-Aventis Investigational Site Number 840255 | Little Rock | Arkansas | 72204 | — |
| Sanofi-Aventis Investigational Site Number 840224 | Little Rock | Arkansas | 72205 | — |
| Sanofi-Aventis Investigational Site Number 840179 | Mountain Home | Arkansas | 72653 | — |
| Sanofi-Aventis Investigational Site Number 840270 | Beverly Hills | California | 90210 | — |
| Sanofi-Aventis Investigational Site Number 840278 | Beverly Hills | California | 90211 | — |
| Sanofi-Aventis Investigational Site Number 840241 | Burbank | California | 91505 | — |
| Sanofi-Aventis Investigational Site Number 840010 | Corona | California | 92879 | — |
| Sanofi-Aventis Investigational Site Number 840195 | Encino | California | 91436 | — |
| Sanofi-Aventis Investigational Site Number 840033 | Loma Linda | California | 92354 | — |
| Sanofi-Aventis Investigational Site Number 840184 | Long Beach | California | 90813 | — |
| Sanofi-Aventis Investigational Site Number 840183 | Los Banos | California | 93635 | — |
| Sanofi-Aventis Investigational Site Number 840272 | Northridge | California | 91325 | — |
| Sanofi-Aventis Investigational Site Number 840213 | Orange | California | 92868 | — |
| Sanofi-Aventis Investigational Site Number 840009 | Redondo Beach | California | 90277 | — |
| Sanofi-Aventis Investigational Site Number 840298 | Riverside | California | 92501 | — |
| Sanofi-Aventis Investigational Site Number 840264 | San Diego | California | 92103 | — |
| Sanofi-Aventis Investigational Site Number 840275 | San Diego | California | 92128 | — |
| Sanofi-Aventis Investigational Site Number 840103 | Santa Ana | California | 92704 | — |
| Sanofi-Aventis Investigational Site Number 840002 | Santa Rosa | California | 95405 | — |
| Sanofi-Aventis Investigational Site Number 840111 | Torrance | California | 90505 | — |
| Sanofi-Aventis Investigational Site Number 840118 | Visalia | California | 93291 | — |
| Sanofi-Aventis Investigational Site Number 840268 | Bridgeport | Connecticut | 06610 | — |
| Sanofi-Aventis Investigational Site Number 840246 | Bay Pines | Florida | 33744 | — |
| Sanofi-Aventis Investigational Site Number 840066 | Beach | Florida | 32168 | — |
| Sanofi-Aventis Investigational Site Number 840313 | Brandon | Florida | 33511 | — |
| Sanofi-Aventis Investigational Site Number 840084 | Dunnellon | Florida | 34432 | — |
| Sanofi-Aventis Investigational Site Number 840138 | Fort Lauderdale | Florida | 33308 | — |
| Sanofi-Aventis Investigational Site Number 840220 | Fort Lauderdale | Florida | 33316 | — |
| Sanofi-Aventis Investigational Site Number 840215 | Gainesville | Florida | 32608 | — |
| Sanofi-Aventis Investigational Site Number 840131 | Hollywood | Florida | 33021 | — |
| Sanofi-Aventis Investigational Site Number 840161 | Hollywood | Florida | 33021 | — |
| Sanofi-Aventis Investigational Site Number 840234 | Key West | Florida | 33040 | — |
| Sanofi-Aventis Investigational Site Number 840112 | Lake Mary | Florida | 32746 | — |
| Sanofi-Aventis Investigational Site Number 840053 | Lakeland | Florida | 33805 | — |
| Sanofi-Aventis Investigational Site Number 840198 | Melbourne | Florida | 32901 | — |
| Sanofi-Aventis Investigational Site Number 840117 | Miami | Florida | 33156 | — |
| Sanofi-Aventis Investigational Site Number 840003 | Niceville | Florida | 32578 | — |
| Sanofi-Aventis Investigational Site Number 840230 | Ocala | Florida | 34471 | — |
| Sanofi-Aventis Investigational Site Number 840202 | Orlando | Florida | 32803 | — |
| Sanofi-Aventis Investigational Site Number 840306 | Orlando | Florida | 32822 | — |
| Sanofi-Aventis Investigational Site Number 840022 | Ormond Beach | Florida | 32174 | — |
| Sanofi-Aventis Investigational Site Number 840110 | Palm Harbor | Florida | 34684 | — |
| Sanofi-Aventis Investigational Site Number 840211 | Plantation | Florida | 33317 | — |
| Sanofi-Aventis Investigational Site Number 840116 | Sanford | Florida | 32271 | — |
| Sanofi-Aventis Investigational Site Number 840243 | Spring Hill | Florida | 34609 | — |
| Sanofi-Aventis Investigational Site Number 840082 | St. Petersburg | Florida | 33701 | — |
| Sanofi-Aventis Investigational Site Number 840012 | St. Petersburg | Florida | 33707 | — |
| Sanofi-Aventis Investigational Site Number 840073 | Atlanta | Georgia | 30342 | — |
| Sanofi-Aventis Investigational Site Number 840273 | Augusta | Georgia | 30909 | — |
| Sanofi-Aventis Investigational Site Number 840204 | Columbus | Georgia | 31904-5245 | — |
| Sanofi-Aventis Investigational Site Number 840290 | Columbus | Georgia | 31904 | — |
| Sanofi-Aventis Investigational Site Number 840225 | Columbus | Georgia | 31907 | — |
| Sanofi-Aventis Investigational Site Number 840305 | Dunwoody | Georgia | 30338 | — |
| Sanofi-Aventis Investigational Site Number 840165 | Savannah | Georgia | 31405 | — |
| Sanofi-Aventis Investigational Site Number 840130 | Idaho Falls | Idaho | 83404 | — |
| Sanofi-Aventis Investigational Site Number 840228 | Idaho Falls | Idaho | 83404 | — |
| Sanofi-Aventis Investigational Site Number 840143 | Nampa | Idaho | 83686 | — |
| Sanofi-Aventis Investigational Site Number 840221 | Chicago | Illinois | 60637 | — |
| Sanofi-Aventis Investigational Site Number 840206 | Chicago | Illinois | 60664 | — |
| Sanofi-Aventis Investigational Site Number 840280 | Beaver City | Indiana | 15009 | — |
| Sanofi-Aventis Investigational Site Number 840014 | Elkhart | Indiana | 46514 | — |
| Sanofi-Aventis Investigational Site Number 840249 | Wichita | Kansas | 67208 | — |
| Sanofi-Aventis Investigational Site Number 840265 | Lexington | Kentucky | 40504 | — |
| Sanofi-Aventis Investigational Site Number 840047 | Alexandria | Louisiana | SUITE 250 | — |
| Sanofi-Aventis Investigational Site Number 840218 | Jena | Louisiana | 71342 | — |
| Sanofi-Aventis Investigational Site Number 840247 | Lafayette | Louisiana | 70503 | — |
| Sanofi-Aventis Investigational Site Number 840158 | Lake Charles | Louisiana | 70601 | — |
| Sanofi-Aventis Investigational Site Number 840077 | Natchitoches | Louisiana | 71457 | — |
| Sanofi-Aventis Investigational Site Number 840259 | Shreveport | Louisiana | 71103 | — |
| Sanofi-Aventis Investigational Site Number 840231 | Shreveport | Louisiana | 71105 | — |
| Sanofi-Aventis Investigational Site Number 840232 | Shreveport | Louisiana | 71105 | — |
| Sanofi-Aventis Investigational Site Number 840145 | Auburn | Maine | 04210 | — |
| Sanofi-Aventis Investigational Site Number 840017 | Baltimore | Maryland | 21237 | — |
| Sanofi-Aventis Investigational Site Number 840317 | Denton | Maryland | 76201 | — |
| Sanofi-Aventis Investigational Site Number 840311 | Alpena | Michigan | 49707 | — |
| Sanofi-Aventis Investigational Site Number 840276 | Brighton | Michigan | 48114 | — |
| Sanofi-Aventis Investigational Site Number 840242 | Detroit | Michigan | 48236 | — |
| Sanofi-Aventis Investigational Site Number 840253 | Grand Rapids | Michigan | 49503 | — |
| Sanofi-Aventis Investigational Site Number 840137 | Saint Clair Shores | Michigan | 48081 | — |
| Sanofi-Aventis Investigational Site Number 840134 | Saint Cloud | Minnesota | 56303 | — |
| Sanofi-Aventis Investigational Site Number 840067 | Gulfport | Mississippi | 39503 | — |
| Sanofi-Aventis Investigational Site Number 840006 | Picayune | Mississippi | 39466 | — |
| Sanofi-Aventis Investigational Site Number 840201 | St Louis | Missouri | 63104 | — |
| Sanofi-Aventis Investigational Site Number 840310 | St Louis | Missouri | 63122 | — |
| Sanofi-Aventis Investigational Site Number 840200 | St Louis | Missouri | 63128 | — |
| Sanofi-Aventis Investigational Site Number 840323 | St Louis | Missouri | 63141 | — |
| Sanofi-Aventis Investigational Site Number 840096 | Anaconda | Montana | 59711 | — |
| Sanofi-Aventis Investigational Site Number 840008 | Butte | Montana | 59701 | — |
| Sanofi-Aventis Investigational Site Number 840126 | Fremont | Nebraska | 68025 | — |
| Sanofi-Aventis Investigational Site Number 840051 | Las Vegas | Nevada | 89119 | — |
| Sanofi-Aventis Investigational Site Number 840258 | Las Vegas | Nevada | 89144 | — |
| Sanofi-Aventis Investigational Site Number 840303 | Hamilton | New Jersey | 08690 | — |
| Sanofi-Aventis Investigational Site Number 840109 | Linden | New Jersey | 07036 | — |
| Sanofi-Aventis Investigational Site Number 840024 | Morristown | New Jersey | 07962-1956 | — |
| Sanofi-Aventis Investigational Site Number 840102 | Buffalo | New York | 14209 | — |
| Sanofi-Aventis Investigational Site Number 840152 | Johnson City | New York | 13790 | — |
| Sanofi-Aventis Investigational Site Number 840159 | Rochester | New York | 14607 | — |
| Sanofi-Aventis Investigational Site Number 840284 | The Bronx | New York | — | — |
| Sanofi-Aventis Investigational Site Number 840056 | Westfield | New York | 14787 | — |
| Sanofi-Aventis Investigational Site Number 840277 | Greensboro | North Carolina | 27401 | — |
| Sanofi-Aventis Investigational Site Number 840196 | Greensboro | North Carolina | 27408 | — |
| Sanofi-Aventis Investigational Site Number 840127 | Hickory | North Carolina | 28602 | — |
| Sanofi-Aventis Investigational Site Number 840150 | Raleigh | North Carolina | 27615 | — |
| Sanofi-Aventis Investigational Site Number 840185 | Rocky Mount | North Carolina | 27804 | — |
| Sanofi-Aventis Investigational Site Number 840020 | Fargo | North Dakota | 58103 | — |
| Sanofi-Aventis Investigational Site Number 840197 | Centerville | Ohio | 45459 | — |
| Sanofi-Aventis Investigational Site Number 840074 | Cincinnati | Ohio | 45267-0525 | — |
| Sanofi-Aventis Investigational Site Number 840146 | Cleveland | Ohio | 44109 | — |
| Sanofi-Aventis Investigational Site Number 840292 | Gallipolis | Ohio | 45631 | — |
| Sanofi-Aventis Investigational Site Number 840026 | Mason | Ohio | 45040 | — |
| Sanofi-Aventis Investigational Site Number 840233 | Toledo | Ohio | 43608 | — |
| Sanofi-Aventis Investigational Site Number 840064 | Wadsworth | Ohio | 44281 | — |
| Sanofi-Aventis Investigational Site Number 840045 | Oklahoma City | Oklahoma | 73104 | — |
| Sanofi-Aventis Investigational Site Number 840133 | Tulsa | Oklahoma | 74104 | — |
| Sanofi-Aventis Investigational Site Number 840113 | Bend | Oregon | 97701 | — |
| Sanofi-Aventis Investigational Site Number 840257 | Portland | Oregon | 97220 | — |
| Sanofi-Aventis Investigational Site Number 840304 | Indiana | Pennsylvania | 15701 | — |
| Sanofi-Aventis Investigational Site Number 840128 | Philadelphia | Pennsylvania | 19102 | — |
| Sanofi-Aventis Investigational Site Number 840160 | Philadelphia | Pennsylvania | 19143 | — |
| Sanofi-Aventis Investigational Site Number 840339 | Philadelphia | Pennsylvania | 19149 | — |
| Sanofi-Aventis Investigational Site Number 840181 | Pittsburgh | Pennsylvania | 15240 | — |
| Sanofi-Aventis Investigational Site Number 840229 | Scotland | Pennsylvania | 17254 | — |
| Sanofi-Aventis Investigational Site Number 840072 | Stoneboro | Pennsylvania | 16153 | — |
| Sanofi-Aventis Investigational Site Number 840248 | Cranston | Rhode Island | 02920 | — |
| Sanofi-Aventis Investigational Site Number 840261 | Anderson | South Carolina | 29621 | — |
| Sanofi-Aventis Investigational Site Number 840297 | Anderson | South Carolina | 29621 | — |
| Sanofi-Aventis Investigational Site Number 840172 | Camden | South Carolina | 29020 | — |
| Sanofi-Aventis Investigational Site Number 840168 | Columbia | South Carolina | 29201 | — |
| Sanofi-Aventis Investigational Site Number 840122 | Manning | South Carolina | 29102 | — |
| Sanofi-Aventis Investigational Site Number 840085 | Newberry | South Carolina | 29108 | — |
| Sanofi-Aventis Investigational Site Number 840189 | Pelzer | South Carolina | 29669 | — |
| Sanofi-Aventis Investigational Site Number 840032 | Fort Meade | South Dakota | 57741 | — |
| Sanofi-Aventis Investigational Site Number 840062 | Athens | Tennessee | 37303 | — |
| Sanofi-Aventis Investigational Site Number 840048 | Bristol | Tennessee | 37620 | — |
| Sanofi-Aventis Investigational Site Number 840052 | Bristol | Tennessee | 37620 | — |
| Sanofi-Aventis Investigational Site Number 840104 | Cleveland | Tennessee | 37312 | — |
| Sanofi-Aventis Investigational Site Number 840129 | Johnson City | Tennessee | 37614 | — |
| Sanofi-Aventis Investigational Site Number 840269 | Nashville | Tennessee | 37203 | — |
| Sanofi-Aventis Investigational Site Number 840076 | Amarillo | Texas | 79106 | — |
| Sanofi-Aventis Investigational Site Number 840252 | Corsicana | Texas | 75110 | — |
| Sanofi-Aventis Investigational Site Number 840286 | Houston | Texas | 77070 | — |
| Sanofi-Aventis Investigational Site Number 840132 | Irving | Texas | 75061 | — |
| Sanofi-Aventis Investigational Site Number 840005 | Odessa | Texas | 79761 | — |
| Sanofi-Aventis Investigational Site Number 840289 | Odessa | Texas | 79761 | — |
| Sanofi-Aventis Investigational Site Number 840186 | San Antonio | Texas | 78234 | — |
| Sanofi-Aventis Investigational Site Number 840194 | San Antonio | Texas | 78238 | — |
| Sanofi-Aventis Investigational Site Number 840236 | Temple | Texas | 76508 | — |
| Sanofi-Aventis Investigational Site Number 840011 | Victoria | Texas | 77901 | — |
| Sanofi-Aventis Investigational Site Number 840285 | Wichita Falls | Texas | 76309 | — |
| Sanofi-Aventis Investigational Site Number 840223 | Clinton | Utah | 84015 | — |
| Sanofi-Aventis Investigational Site Number 840238 | Salt Lake City | Utah | 84124 | — |
| Sanofi-Aventis Investigational Site Number 840308 | Salt Lake City | Utah | 84124 | — |
| Sanofi-Aventis Investigational Site Number 840068 | Salem | Virginia | 24153 | — |
| Sanofi-Aventis Investigational Site Number 840219 | Springfield | Virginia | 22151 | — |
| Sanofi-Aventis Investigational Site Number 840058 | Everett | Washington | 98201 | — |
| Sanofi-Aventis Investigational Site Number 840123 | Seattle | Washington | 98111 | — |
| Sanofi-Aventis Investigational Site Number 840019 | Tacoma | Washington | 98405 | — |
| Sanofi-Aventis Investigational Site Number 840256 | Beloit | Wisconsin | 53511 | — |
| Sanofi-Aventis Investigational Site Number 840293 | Madison | Wisconsin | 53713 | — |
| Sanofi-Aventis Investigational Site Number 840282 | Wauwatosa | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 376 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00580216, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2016 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00580216 live on ClinicalTrials.gov.