Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)

PHASE4CompletedINTERVENTIONAL
Enrollment

3,235

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

May 31, 2010

Study Completion Date

May 31, 2010

Conditions
Acute Coronary Syndrome
Interventions
DRUG

fondaparinux background and standard dose UFH

Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned glycoprotein \[GP\] IIb/IIIa inhibitor use: 60 units/kilogram (U/kg); no planned use: 85 U/kg and adjusted based on activated clotting time (ACT) \[maximum two additional bolus doses\]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

DRUG

Fondaparinux background and low dose heparin

Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose UFH (50 U/kg), which was not adjusted for planned GPIIb/IIIa inhibitor use or ACT). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

DRUG

Open label fondaparinux

Open-label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for PCI and not randomized

Trial Locations (203)

1000

GSK Investigational Site, Sofia

1096

GSK Investigational Site, Budapest

1106

GSK Investigational Site, Budapest

1122

GSK Investigational Site, Budapest

1309

GSK Investigational Site, Sofia

1407

GSK Investigational Site, Sofia

1428

GSK Investigational Site, Buenos Aires

1709

GSK Investigational Site, Sofia

3526

GSK Investigational Site, Miskolc

4002

GSK Investigational Site, Plovdiv

4032

GSK Investigational Site, Debrecen

7624

GSK Investigational Site, Pécs

8001

GSK Investigational Site, Bahía Blanca

8230

GSK Investigational Site, Balatonfüred

8900

GSK Investigational Site, Zalaegerszeg

10249

GSK Investigational Site, Berlin

12683

GSK Investigational Site, Berlin

13210

GSK Investigational Site, Syracuse

13353

GSK Investigational Site, Berlin

13385

GSK Investigational Site, Marseille

14033

GSK Investigational Site, Caen

15706

GSK Investigational Site, Santiago de Compostela

16321

GSK Investigational Site, Bernau bei Berlin

18057

GSK Investigational Site, Rostock

20089

GSK Investigational Site, Rozzano (Mi)

20138

GSK Investigational Site, Milan

20246

GSK Investigational Site, Hamburg

21079

GSK Investigational Site, Dijon

22527

GSK Investigational Site, Hamburg

23538

GSK Investigational Site, Lübeck

24071

GSK Investigational Site, León

24534

GSK Investigational Site, Neumünster

25030

GSK Investigational Site, Besançon

26100

GSK Investigational Site, Cremona

27100

GSK Investigational Site, Pavia

28006

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28047

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Novara

28277

GSK Investigational Site, Bremen

29010

GSK Investigational Site, Málaga

31059

GSK Investigational Site, Toulouse

32049

GSK Investigational Site, Herford

33006

GSK Investigational Site, Oviedo

33100

GSK Investigational Site, Udine

34121

GSK Investigational Site, Kassel

34471

GSK Investigational Site, Ocala

36200

GSK Investigational Site, Vigo/Pontevedra

37044

GSK Investigational Site, Tours

37075

GSK Investigational Site, Göttingen

40133

GSK Investigational Site, Bologna

41014

GSK Investigational Site, Seville

41063

GSK Investigational Site, Mönchengladbach

41464

GSK Investigational Site, Neuss

44100

GSK Investigational Site, Ferrara

46100

GSK Investigational Site, Mantova

48960

GSK Investigational Site, Galdakao

49214

GSK Investigational Site, Bad Rothenfelde

50937

GSK Investigational Site, Cologne

53127

GSK Investigational Site, Bonn

55100

GSK Investigational Site, Lucca

55131

GSK Investigational Site, Mainz

58452

GSK Investigational Site, Witten

63225

GSK Investigational Site, Langen

65428

GSK Investigational Site, Rüsselsheim am Main

66421

GSK Investigational Site, Homburg

69120

GSK Investigational Site, Heidelberg

75216

GSK Investigational Site, Dallas

75877

GSK Investigational Site, Paris

76031

GSK Investigational Site, Rouen

83646

GSK Investigational Site, Bad Tölz

84359

GSK Investigational Site, Simbach A. Inn

85221

GSK Investigational Site, Dachau

87106

GSK Investigational Site, Albuquerque

89522

GSK Investigational Site, Heidenheim

91054

GSK Investigational Site, Erlangen

93370

GSK Investigational Site, Montfermeil

94010

GSK Investigational Site, Créteil

99089

GSK Investigational Site, Erfurt

109240

GSK Investigational Site, Moscow

110017

GSK Investigational Site, New Delhi

110060

GSK Investigational Site, New Delhi

111539

GSK Investigational Site, Moscow

121359

GSK Investigational Site, Moscow

121552

GSK Investigational Site, Moscow

150062

GSK Investigational Site, Yaroslavl

194156

GSK Investigational Site, St'Petersburg

195067

GSK Investigational Site, Saint Petersburg

226014

GSK Investigational Site, Lucknow

302001

GSK Investigational Site, Jaipur

350086

GSK Investigational Site, Krasnodar

380015

GSK Investigational Site, Ahmedabad

380052

GSK Investigational Site, Ahmedabad

380054

GSK Investigational Site, Ahmedabad

390015

GSK Investigational Site, Vadodara

394066

GSK Investigational Site, Voronezh

400050

GSK Investigational Site, Bandra, Mumbai

411001

GSK Investigational Site, Pune

411030

GSK Investigational Site, Pune

440012

GSK Investigational Site, Dhantoli, Nagpur

500003

GSK Investigational Site, Secunderabad

560034

GSK Investigational Site, Bangalore

614107

GSK Investigational Site, Perm

630055

GSK Investigational Site, Novosibirsk

634012

GSK Investigational Site, Tomsk

650002

GSK Investigational Site, Kemerovo

656055

GSK Investigational Site, Barnaul

13059740

GSK Investigational Site, Campinas

15015210

GSK Investigational Site, São José do Rio Preto

80320320

GSK Investigational Site, Curitiba

83430000

GSK Investigational Site, Campina Grande do Sul

90620001

GSK Investigational Site, Porto Alegre

B1846DSK

GSK Investigational Site, Adrogué

B1900AXI

GSK Investigational Site, La Plata

B1722COV

GSK Investigational Site, Merlo

B1878CBI

GSK Investigational Site, Quilmes

B1878DFK

GSK Investigational Site, Quilmes

S2000CHT

GSK Investigational Site, Rosario

W3400AMZ

GSK Investigational Site, Corrientes

S2000DSR

GSK Investigational Site, Rosario

S3000AZG

GSK Investigational Site, Santa Fe

S3000FUJ

GSK Investigational Site, Santa Fe

T4000NIL

GSK Investigational Site, San Miguel de Tucumán

90035-903

GSK Investigational Site, Porto Alegre

90880-480

GSK Investigational Site, Porto Alegre

89010-906

GSK Investigational Site, Blumenau

17515-900

GSK Investigational Site, Marília

15090-000

GSK Investigational Site, São José do Rio Preto

T2N 2T9

GSK Investigational Site, Calgary

L8L 2X2

GSK Investigational Site, Hamilton

N6A 5A5

GSK Investigational Site, London

M4N 3M5

GSK Investigational Site, Toronto

G7H 5H6

GSK Investigational Site, Chicoutimi

H1T 1C8

GSK Investigational Site, Montreal

H2W 1T8

GSK Investigational Site, Montreal

H4J 1C5

GSK Investigational Site, Montreal

G1V 4G5

GSK Investigational Site, Québec

656 91

GSK Investigational Site, Brno

500 05

GSK Investigational Site, Hradec Králové

360 66

GSK Investigational Site, Karlovy Vary

304 60

GSK Investigational Site, Pilsen

100 34

GSK Investigational Site, Prague

128 00

GSK Investigational Site, Prague

150 06

GSK Investigational Site, Prague

400 11

GSK Investigational Site, Ústí nad Labem

762 75

GSK Investigational Site, Zlín

03048

GSK Investigational Site, Cottbus

01307

GSK Investigational Site, Dresden

04289

GSK Investigational Site, Leipzig

06120

GSK Investigational Site, Halle

06484

GSK Investigational Site, Quedlinburg

115 26

GSK Investigational Site, Athens

115 27

GSK Investigational Site, Athens

124 62

GSK Investigational Site, Athens

151 27

GSK Investigational Site, Athens

176 74

GSK Investigational Site, Athens

45 500

GSK Investigational Site, Ioannina

26 504

GSK Investigational Site, Rio- Patras

Unknown

GSK Investigational Site, Dhantoli, Nagpur

GSK Investigational Site, Gyeonggi-do

GSK Investigational Site, Seoul

GSK Investigational Site, Southampton

07100

GSK Investigational Site, Sassari

06156

GSK Investigational Site, Perugia

5623 EJ

GSK Investigational Site, Eindhoven

3435 CM

GSK Investigational Site, Nieuwegein

3075 EA

GSK Investigational Site, Rotterdam

15-276

GSK Investigational Site, Bialystok

41-902

GSK Investigational Site, Bytom

42-200

GSK Investigational Site, Częstochowa

41-300

GSK Investigational Site, Dąbrowa Górnicza

80-952

GSK Investigational Site, Gdansk

81-348

GSK Investigational Site, Gdynia

75-581

GSK Investigational Site, Koszalin

31-202

GSK Investigational Site, Krakow

31-501

GSK Investigational Site, Krakow

59-301

GSK Investigational Site, Lubin

26-617

GSK Investigational Site, Radom

87-100

GSK Investigational Site, Torun

02-637

GSK Investigational Site, Warsaw

04-073

GSK Investigational Site, Warsaw

58-309

GSK Investigational Site, Wałbrzych

51-124

GSK Investigational Site, Wroclaw

87-800

GSK Investigational Site, Włocławek

602-715

GSK Investigational Site, Busan

302-718

GSK Investigational Site, Daejeon

135-710

GSK Investigational Site, Gangnam-gu, Seoul

411-773

GSK Investigational Site, Goyang-si, Gyeonggi-do

501-717

GSK Investigational Site, Gwangju

501-757

GSK Investigational Site, Gwangju

561-712

GSK Investigational Site, Jeonju-si, Jeollabuk-Do

134-090

GSK Investigational Site, Seoul

138-736

GSK Investigational Site, Seoul

152-703

GSK Investigational Site, Seoul

158-710

GSK Investigational Site, Seoul

03010

GSK Investigational Site, Alicante

07014

GSK Investigational Site, Palma de Mallorca

B15 2TH

GSK Investigational Site, Birmingham

BS2 8HW

GSK Investigational Site, Bristol

DD1 9SY

GSK Investigational Site, Dundee

EH16 4SA

GSK Investigational Site, Edinburgh

SW17 0QT

GSK Investigational Site, Tooting, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY