Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications

To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Study Overview

• Status: Completed
• Conditions: Thrombosis, Venous
• Intervention / Treatment: Drug: Fondaparinux 2.5mg or placebo

Detailed Description

Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

• Study Type: Interventional
• Enrollment (Actual): 3002
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1309
    • GSK Investigational Site
• Czech Republic
  • Brno, Czech Republic, 656 91
    • GSK Investigational Site
  • Olomouc, Czech Republic, 775 20
    • GSK Investigational Site
  • Plzen, Czech Republic, 323 18
    • GSK Investigational Site
  • Praha 10, Czech Republic, 101 00
    • GSK Investigational Site
  • Praha 10, Czech Republic, 108 00
    • GSK Investigational Site
  • Praha 2, Czech Republic, 12808
    • GSK Investigational Site
  • Praha 4, Czech Republic, 140 00
    • GSK Investigational Site
  • Praha 5, Czech Republic, 150 05
    • GSK Investigational Site
  • Praha 6, Czech Republic, 169 02
    • GSK Investigational Site
  • Ricany, Czech Republic, 251 01
    • GSK Investigational Site
  • Tabor, Czech Republic, 390 03
    • GSK Investigational Site
• Estonia
  • Saku, Estonia, 75501
    • GSK Investigational Site
  • Tallinn, Estonia, 10617
    • GSK Investigational Site
  • Tallinn, Estonia, 10138
    • GSK Investigational Site
  • Tartu, Estonia, 50410
    • GSK Investigational Site
• France
  • Abbeville, France, 80100
    • GSK Investigational Site
  • Ales, France, 30100
    • GSK Investigational Site
  • Amiens, France, 80054
    • GSK Investigational Site
  • Annecy, France, 74000
    • GSK Investigational Site
  • Annonay, France, 07100
    • GSK Investigational Site
  • Arras, France, 62000
    • GSK Investigational Site
  • Bordeaux, France, 33082
    • GSK Investigational Site
  • Brest, France, 29200
    • GSK Investigational Site
  • Clermont Ferrand, France, 63000
    • GSK Investigational Site
  • Grenoble, France, 38000
    • GSK Investigational Site
  • Montpellier, France, 34295
    • GSK Investigational Site
  • Nice, France, 06000
    • GSK Investigational Site
  • Nîmes Cedex 9, France, 30029
    • GSK Investigational Site
  • Saint Aubin sur Scie, France, 76550
    • GSK Investigational Site
  • Saint-Priest en Jarez, France, 42270
    • GSK Investigational Site
  • Tarbes, France, 65000
    • GSK Investigational Site
  • Toulon, France, 83000
    • GSK Investigational Site
  • Toulouse, France, 31000
    • GSK Investigational Site
  • Valenciennes, France, 59300
    • GSK Investigational Site
  • Villeurbanne, France, 69100
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10789
    • GSK Investigational Site
  • Berlin, Germany, 10559
    • GSK Investigational Site
  • Berlin, Germany, 12627
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hamburg, Germany, 22081
    • GSK Investigational Site
  • Hamburg, Germany, 22177
    • GSK Investigational Site
  • Hamburg, Germany, 22761
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Baesweiler, Baden-Wuerttemberg, Germany, 52499
      • GSK Investigational Site
    • Freiburg, Baden-Wuerttemberg, Germany, 79108
      • GSK Investigational Site
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • GSK Investigational Site
    • Karlsbad, Baden-Wuerttemberg, Germany, 76307
      • GSK Investigational Site
    • Karlsruhe, Baden-Wuerttemberg, Germany, 76133
      • GSK Investigational Site
    • Lauffen, Baden-Wuerttemberg, Germany, 74348
      • GSK Investigational Site
  • Bayern
    • Augsburg, Bayern, Germany, 86150
      • GSK Investigational Site
    • Grossheirath, Bayern, Germany, 96269
      • GSK Investigational Site
    • Hemau, Bayern, Germany, 93155
      • GSK Investigational Site
    • Muehldorf, Bayern, Germany, 84453
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80336
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80333
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80331
      • GSK Investigational Site
    • Noerdlingen, Bayern, Germany, 86720
      • GSK Investigational Site
    • Nuernberg, Bayern, Germany, 90429
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site
  • Brandenburg
    • Dahlwitz-Hoppegarten, Brandenburg, Germany, 15366
      • GSK Investigational Site
    • Potsdam, Brandenburg, Germany, 14482
      • GSK Investigational Site
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • GSK Investigational Site
    • Eschwege, Hessen, Germany, 37269
      • GSK Investigational Site
    • Frankfurt, Hessen, Germany, 60322
      • GSK Investigational Site
    • Wiesbaden, Hessen, Germany, 65183
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18059
      • GSK Investigational Site
  • Niedersachsen
    • Bad Bevensen, Niedersachsen, Germany, 29549
      • GSK Investigational Site
    • Leer, Niedersachsen, Germany, 26789
      • GSK Investigational Site
    • Osnabrueck, Niedersachsen, Germany, 49074
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen-Kettwig, Nordrhein-Westfalen, Germany, 45219
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50760
      • GSK Investigational Site
    • Koeln-Junkersdorf, Nordrhein-Westfalen, Germany, 50858
      • GSK Investigational Site
    • Moenchengladbach, Nordrhein-Westfalen, Germany, 41065
      • GSK Investigational Site
    • Neuss, Nordrhein-Westfalen, Germany, 41460
      • GSK Investigational Site
    • Oberhausen, Nordrhein-Westfalen, Germany, 46145
      • GSK Investigational Site
    • Waldbroel, Nordrhein-Westfalen, Germany, 51545
      • GSK Investigational Site
    • Wuppertal, Nordrhein-Westfalen, Germany, 42275
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Frankenthal, Rheinland-Pfalz, Germany, 67227
      • GSK Investigational Site
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67059
      • GSK Investigational Site
    • Neustadt, Rheinland-Pfalz, Germany, 67434
      • GSK Investigational Site
  • Saarland
    • Neunkirchen, Saarland, Germany, 66538
      • GSK Investigational Site
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09130
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01309
      • GSK Investigational Site
    • Kirchberg, Sachsen, Germany, 08107
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04109
      • GSK Investigational Site
  • Thueringen
    • Altenburg, Thueringen, Germany, 04600
      • GSK Investigational Site
    • Jena, Thueringen, Germany, 07743
      • GSK Investigational Site
    • Nordhausen, Thueringen, Germany, 99734
      • GSK Investigational Site
• Greece
  • Alexandroupolis, Greece, 68100
    • GSK Investigational Site
  • Athens, Greece, 115 27
    • GSK Investigational Site
  • Athens, Greece, 145 61
    • GSK Investigational Site
  • Heraklion, Greece, 712 01
    • GSK Investigational Site
  • Larisa, Greece, 41110
    • GSK Investigational Site
  • Melissia Athens, Greece, 15127
    • GSK Investigational Site
  • Thessaloniki, Greece, 54642
    • GSK Investigational Site
  • Thessaloniki, Greece, 56429
    • GSK Investigational Site
• Hungary
  • Bekescsaba, Hungary, 5600
    • GSK Investigational Site
  • Budapest, Hungary, 1083
    • GSK Investigational Site
  • Budapest, Hungary, 1122
    • GSK Investigational Site
  • Budapest, Hungary, 1096
    • GSK Investigational Site
  • Budapest, Hungary, 1106
    • GSK Investigational Site
  • Budapest, Hungary, 1039
    • GSK Investigational Site
  • Budapest, Hungary, 1115
    • GSK Investigational Site
  • Budapest, Hungary, 1081
    • GSK Investigational Site
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
  • Esztergom, Hungary, 2500
    • GSK Investigational Site
  • Gyula, Hungary, 5700
    • GSK Investigational Site
  • Kaposvár, Hungary, 7400
    • GSK Investigational Site
  • Miskolc, Hungary, 3501
    • GSK Investigational Site
  • Nyiregyháza, Hungary, 4400
    • GSK Investigational Site
  • Pécs, Hungary, 7623
    • GSK Investigational Site
  • Szikszó, Hungary, 8300
    • GSK Investigational Site
  • Székesfehérvár, Hungary, 8000
    • GSK Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • GSK Investigational Site
• Israel
  • Afula, Israel, 18101
    • GSK Investigational Site
  • Ashkelon, Israel, 78306
    • GSK Investigational Site
  • Haifa, Israel, 31096
    • GSK Investigational Site
  • Kfar Saba, Israel, 44281
    • GSK Investigational Site
  • Petach Tikva, Israel, 49100
    • GSK Investigational Site
  • Safed, Israel, 13110
    • GSK Investigational Site
  • Tel-Aviv, Israel, 64239
    • GSK Investigational Site
• Italy
  • Abruzzo
    • Chieti Scalo, Abruzzo, Italy, 66013
      • GSK Investigational Site
  • Campania
    • Napoli, Campania, Italy, 80131
      • GSK Investigational Site
  • Emilia-Romagna
    • Piacenza, Emilia-Romagna, Italy, 29100
      • GSK Investigational Site
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • GSK Investigational Site
    • Rimini, Emilia-Romagna, Italy, 47900
      • GSK Investigational Site
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20122
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20142
      • GSK Investigational Site
    • Pavia, Lombardia, Italy, 27100
      • GSK Investigational Site
  • Sicilia
    • Palermo, Sicilia, Italy, 90126
      • GSK Investigational Site
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • GSK Investigational Site
  • Veneto
    • Padova, Veneto, Italy, 35128
      • GSK Investigational Site
    • Venezia, Veneto, Italy, 30122
      • GSK Investigational Site
• Latvia
  • Daugavpils, Latvia, LV5417
    • GSK Investigational Site
  • Riga, Latvia, LV 1002
    • GSK Investigational Site
  • Riga, Latvia, LV1038
    • GSK Investigational Site
  • Riga, Latvia, LV 1012
    • GSK Investigational Site
• Netherlands
  • Alkmaar, Netherlands, 1815 KX
    • GSK Investigational Site
  • Amsterdam, Netherlands, 1105 AZ
    • GSK Investigational Site
  • Amsterdam, Netherlands, 1066 EC
    • GSK Investigational Site
  • Den Haag, Netherlands, 2566 MJ
    • GSK Investigational Site
  • Maastricht, Netherlands, 6229 HX
    • GSK Investigational Site
  • Weerselo, Netherlands, 7651 JH
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-276
    • GSK Investigational Site
  • Bydgoszcz, Poland, 85-168
    • GSK Investigational Site
  • Gniewkowo, Poland, 88-140
    • GSK Investigational Site
  • Grudziadz, Poland, 86-300
    • GSK Investigational Site
  • Poznan, Poland, 61-848
    • GSK Investigational Site
  • Wroclaw, Poland, 50-349
    • GSK Investigational Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • GSK Investigational Site
  • Barnaul, Russian Federation, 656038
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620102
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620028
    • GSK Investigational Site
  • Irkutsk, Russian Federation, 664003
    • GSK Investigational Site
  • Kemerovo, Russian Federation, 650002
    • GSK Investigational Site
  • Kursk, Russian Federation, 305035
    • GSK Investigational Site
  • Lipetsk, Russian Federation, 398055
    • GSK Investigational Site
  • Moscow, Russian Federation, 119049
    • GSK Investigational Site
  • Moscow, Russian Federation
    • GSK Investigational Site
  • Moscow, Russian Federation, 115 280
    • GSK Investigational Site
  • Moscow, Russian Federation, 111538
    • GSK Investigational Site
  • Moscow, Russian Federation, 125299
    • GSK Investigational Site
  • Moscow, Russian Federation, 119 048
    • GSK Investigational Site
  • Moscow, Russian Federation, 630117
    • GSK Investigational Site
  • Perm, Russian Federation, 614107
    • GSK Investigational Site
  • Perm, Russian Federation, 614990
    • GSK Investigational Site
  • Rostov-na-Donu, Russian Federation, 344019
    • GSK Investigational Site
  • Ryazan, Russian Federation, 390026
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 198260
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 197046
    • GSK Investigational Site
  • Samara, Russian Federation, 443099
    • GSK Investigational Site
  • Saratov, Russian Federation, 4100017
    • GSK Investigational Site
  • St. Petersburgh, Russian Federation, 192242
    • GSK Investigational Site
  • Stavropol, Russian Federation, 310
    • GSK Investigational Site
  • Tomsk, Russian Federation, 634063
    • GSK Investigational Site
  • Tomsk, Russian Federation, 630117
    • GSK Investigational Site
  • Tumen, Russian Federation, 625023
    • GSK Investigational Site
  • Ufa, Russian Federation, 450000
    • GSK Investigational Site
  • Voronezh, Russian Federation, 394066
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150003
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150023
    • GSK Investigational Site
• Slovakia
  • Bardejov, Slovakia, 085 01
    • GSK Investigational Site
  • Bratislava, Slovakia, 813 69
    • GSK Investigational Site
  • Bratislava, Slovakia, 833 05
    • GSK Investigational Site
  • Kosice, Slovakia, 040 01
    • GSK Investigational Site
  • Kosice, Slovakia, 040 86
    • GSK Investigational Site
  • Nitra, Slovakia, 949 01
    • GSK Investigational Site
  • Presov, Slovakia, 080 01
    • GSK Investigational Site
  • Zilina, Slovakia, 010 01
    • GSK Investigational Site
• Spain
  • Avila, Spain, 05071
    • GSK Investigational Site
  • Boadilla del Monte (Madrid), Spain, 28660
    • GSK Investigational Site
  • Cartagena (Murcia), Spain, 30203
    • GSK Investigational Site
  • Getafe, Spain, 28905
    • GSK Investigational Site
  • Gijon, Spain, 33394
    • GSK Investigational Site
  • Hospitalet de Llobregat, Spain, 08907
    • GSK Investigational Site
  • Marid, Spain, 28040
    • GSK Investigational Site
  • Mataro, Spain, 08034
    • GSK Investigational Site
  • Palma de Mallorca, Spain, 07014
    • GSK Investigational Site
  • Sabadell (Barcelona), Spain, 08208
    • GSK Investigational Site
  • San Juan De Alicante, Spain, 3550
    • GSK Investigational Site
  • Segovia, Spain, 40002
    • GSK Investigational Site
  • Valencia, Spain, 46017
    • GSK Investigational Site
  • Valladolid, Spain, 47005
    • GSK Investigational Site
  • Zamora, Spain, 49021
    • GSK Investigational Site
• Switzerland
  • Bern, Switzerland, 3010
    • GSK Investigational Site
  • Bruderholz, Switzerland, 4101
    • GSK Investigational Site
  • Fribourg, Switzerland, 1708
    • GSK Investigational Site
  • Geneve, Switzerland, 1211
    • GSK Investigational Site
  • Lausanne, Switzerland, 1005
    • GSK Investigational Site
  • Luzern, Switzerland, 6000
    • GSK Investigational Site
  • Zuerich, Switzerland, 8091
    • GSK Investigational Site
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • GSK Investigational Site
  • Dnipropetrovsk, Ukraine, 49005
    • GSK Investigational Site
  • Donetsk, Ukraine, 83045
    • GSK Investigational Site
  • Ivano-Frankivsk, Ukraine, 76000
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61018
    • GSK Investigational Site
  • Kyiv, Ukraine, 03680
    • GSK Investigational Site
  • Kyiv, Ukraine, 01601
    • GSK Investigational Site
  • Kyiv, Ukraine, 04201
    • GSK Investigational Site
  • Lviv, Ukraine, 79010
    • GSK Investigational Site
  • Sevastopol, Ukraine, 99011
    • GSK Investigational Site
  • Uzhgorod, Ukraine, 88010
    • GSK Investigational Site
  • Vinnitsa, Ukraine, 21018
    • GSK Investigational Site
  • Zaporizhzhya, Ukraine, 69000
    • GSK Investigational Site
  • Zaporizhzhya, Ukraine, 69600
    • GSK Investigational Site
  • Zaporizhzhya, Ukraine, 69065
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.

Exclusion criteria:

• Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
• deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,
• anticoagulant medication for more than 48 hours prior to inclusion,
• need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,
• major surgery within last 3 months, low platelet count (below 100×109/L),
• kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing potential not using reliable contraceptive method

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Fondaparinux 2.5mg or placebo; Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
ACTIVE_COMPARATOR: Fondaparinux 2.5mg	Drug: Fondaparinux 2.5mg or placebo; Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.	Baseline to Day 47

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.	Baseline to Day 77
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.	Days 47 and 77
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77	The number of participants requiring surgery was measured.	Days 47 and 77
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77	Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.	Days 47 (or last dose plus 4 days) and 77
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77	Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.	Days 47 (or last dose plus 4 days) and 77
Number of Any Adjudicated Bleeding Events at Days 47 and 77	The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.	Days 47 (or last dose plus 4 days) and 77

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Leizorovicz A, Becker F, Buchmuller A, Quere I, Prandoni P, Decousus H; CALISTO Study Group. Clinical relevance of symptomatic superficial-vein thrombosis extension: lessons from the CALISTO study. Blood. 2013 Sep 5;122(10):1724-9. doi: 10.1182/blood-2013-04-498014. Epub 2013 Jul 2.
• Decousus H, Prandoni P, Mismetti P, Bauersachs RM, Boda Z, Brenner B, Laporte S, Matyas L, Middeldorp S, Sokurenko G, Leizorovicz A; CALISTO Study Group. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med. 2010 Sep 23;363(13):1222-32. doi: 10.1056/NEJMoa0912072.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: March 2, 2007
• First Submitted That Met QC Criteria: March 2, 2007
• First Posted (ESTIMATE): March 5, 2007

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: fondaparinux; deep vein thrombosis; thrombosis; superficial vein thrombosis; superficial thrombophlebitis; venous thromboembolism treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Peripheral Vascular Diseases; Phlebitis; Thrombosis; Venous Thrombosis; Thrombophlebitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Fondaparinux; PENTA
• Other Study ID Numbers: ART108053