Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA/OASIS 8)

FondaparinUx Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction (UA/NSTEMI) Initially Treated With Subcutaneous Fondaparinux and Referred for Early Coronary Angiography (OASIS 8)

The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: fondaparinux background and standard dose UFH; Drug: Fondaparinux background and low dose heparin; Drug: Open label fondaparinux

Detailed Description

Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo angiography (ideally within 72 hours) will be assessed for eligibility and consented. Suitable subjects will be enrolled and commence treatment with open-label fondaparinux, 2.5 milligram (mg), subcutaneous (s.c.), once daily. Following angiography subjects indicated for PCI and meeting the additional requirements for randomization will be randomised to receive one of two dose regimens of UFH either standard dose or low dose immediately prior to the PCI procedure. Post-PCI, therapy with fondaparinux (2.5 mg, s.c.) may be resumed at the investigator's discretion for up to a maximum of 8 days or hospital discharge, whichever is earlier.

Subjects not indicated for PCI, will continue treatment with fondaparinux, 2.5mg, s.c, once daily for up to 8 days or hospital discharge, whichever is earlier.

All subjects will be followed up for 30 days after randomization/angiography.

• Study Type: Interventional
• Enrollment (Actual): 3235
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1428
    • GSK Investigational Site
  • Corrientes, Argentina, W3400AMZ
    • GSK Investigational Site
  • San Miguel de Tucumán, Argentina, T4000NIL
    • GSK Investigational Site
  • Santa Fe, Argentina, S3000AZG
    • GSK Investigational Site
  • Santa Fe, Argentina, S3000FUJ
    • GSK Investigational Site
  • Buenos Aires
    • Adrogue, Buenos Aires, Argentina, B1846DSK
      • GSK Investigational Site
    • Bahia Blanca, Buenos Aires, Argentina, 8001
      • GSK Investigational Site
    • La Plata, Buenos Aires, Argentina, B1900AXI
      • GSK Investigational Site
    • Merlo, Buenos Aires, Argentina, B1722COV
      • GSK Investigational Site
    • Quilmes, Buenos Aires, Argentina, B1878CBI
      • GSK Investigational Site
    • Quilmes, Buenos Aires, Argentina, B1878DFK
      • GSK Investigational Site
    • Rosario, Buenos Aires, Argentina, S2000CHT
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSR
      • GSK Investigational Site
• Brazil
  • Paraná
    • Campina Grande do Sul, Paraná, Brazil, 83430000
      • GSK Investigational Site
    • Curitiba, Paraná, Brazil, 80320320
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • GSK Investigational Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620001
      • GSK Investigational Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90880-480
      • GSK Investigational Site
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-906
      • GSK Investigational Site
  • São Paulo
    • Campinas, São Paulo, Brazil, 13059740
      • GSK Investigational Site
    • Marília, São Paulo, Brazil, 17515-900
      • GSK Investigational Site
    • São José do Rio Preto, São Paulo, Brazil, 15015210
      • GSK Investigational Site
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • GSK Investigational Site
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • GSK Investigational Site
  • Sofia, Bulgaria, 1407
    • GSK Investigational Site
  • Sofia, Bulgaria, 1000
    • GSK Investigational Site
  • Sofia, Bulgaria, 1709
    • GSK Investigational Site
  • Sofia, Bulgaria, 1309
    • GSK Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • GSK Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • GSK Investigational Site
    • London, Ontario, Canada, N6A 5A5
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M4N 3M5
      • GSK Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H4J 1C5
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2W 1T8
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H1T 1C8
      • GSK Investigational Site
    • Quebec City, Quebec, Canada, G1V 4G5
      • GSK Investigational Site
• Czech Republic
  • Brno, Czech Republic, 656 91
    • GSK Investigational Site
  • Hradec Kralove, Czech Republic, 500 05
    • GSK Investigational Site
  • Karlovy Vary, Czech Republic, 360 66
    • GSK Investigational Site
  • Plzen, Czech Republic, 304 60
    • GSK Investigational Site
  • Praha 10, Czech Republic, 100 34
    • GSK Investigational Site
  • Praha 2, Czech Republic, 128 00
    • GSK Investigational Site
  • Praha 5, Czech Republic, 150 06
    • GSK Investigational Site
  • Usti nad Labem, Czech Republic, 400 11
    • GSK Investigational Site
  • Zlin, Czech Republic, 762 75
    • GSK Investigational Site
• France
  • Besançon Cedex, France, 25030
    • GSK Investigational Site
  • Caen Cedex 9, France, 14033
    • GSK Investigational Site
  • Créteil, France, 94010
    • GSK Investigational Site
  • Dijon, France, 21079
    • GSK Investigational Site
  • Marseille Cedex 05, France, 13385
    • GSK Investigational Site
  • Montfermeil, France, 93370
    • GSK Investigational Site
  • Paris Cedex 18, France, 75877
    • GSK Investigational Site
  • Rouen Cedex, France, 76031
    • GSK Investigational Site
  • Toulouse cedex 9, France, 31059
    • GSK Investigational Site
  • Tours cedex 09, France, 37044
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13353
    • GSK Investigational Site
  • Berlin, Germany, 10249
    • GSK Investigational Site
  • Berlin, Germany, 12683
    • GSK Investigational Site
  • Bremen, Germany, 28277
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 22527
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • GSK Investigational Site
    • Heidenheim, Baden-Wuerttemberg, Germany, 89522
      • GSK Investigational Site
  • Bayern
    • Bad Toelz, Bayern, Germany, 83646
      • GSK Investigational Site
    • Dachau, Bayern, Germany, 85221
      • GSK Investigational Site
    • Erlangen, Bayern, Germany, 91054
      • GSK Investigational Site
    • Simbach a. Inn, Bayern, Germany, 84359
      • GSK Investigational Site
  • Brandenburg
    • Bernau, Brandenburg, Germany, 16321
      • GSK Investigational Site
    • Cottbus, Brandenburg, Germany, 03048
      • GSK Investigational Site
  • Hessen
    • Kassel, Hessen, Germany, 34121
      • GSK Investigational Site
    • Langen, Hessen, Germany, 63225
      • GSK Investigational Site
    • Ruesselsheim, Hessen, Germany, 65428
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18057
      • GSK Investigational Site
  • Niedersachsen
    • Bad Rothenfelde, Niedersachsen, Germany, 49214
      • GSK Investigational Site
    • Goettingen, Niedersachsen, Germany, 37075
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • GSK Investigational Site
    • Herford, Nordrhein-Westfalen, Germany, 32049
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50937
      • GSK Investigational Site
    • Moenchengladbach, Nordrhein-Westfalen, Germany, 41063
      • GSK Investigational Site
    • Neuss, Nordrhein-Westfalen, Germany, 41464
      • GSK Investigational Site
    • Witten, Nordrhein-Westfalen, Germany, 58452
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04289
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06120
      • GSK Investigational Site
    • Quedlinburg, Sachsen-Anhalt, Germany, 06484
      • GSK Investigational Site
  • Schleswig-Holstein
    • Luebeck, Schleswig-Holstein, Germany, 23538
      • GSK Investigational Site
    • Neumuenster, Schleswig-Holstein, Germany, 24534
      • GSK Investigational Site
  • Thueringen
    • Erfurt, Thueringen, Germany, 99089
      • GSK Investigational Site
• Greece
  • Athens, Greece, 115 27
    • GSK Investigational Site
  • Athens, Greece, 115 26
    • GSK Investigational Site
  • Athens, Greece, 124 62
    • GSK Investigational Site
  • Athens, Greece, 151 27
    • GSK Investigational Site
  • Athens, Greece, 176 74
    • GSK Investigational Site
  • Ioannina, Greece, 45 500
    • GSK Investigational Site
  • Rio- Patras, Greece, 26 504
    • GSK Investigational Site
• Hungary
  • Balatonfüred, Hungary, 8230
    • GSK Investigational Site
  • Budapest, Hungary, 1122
    • GSK Investigational Site
  • Budapest, Hungary, 1096
    • GSK Investigational Site
  • Budapest, Hungary, 1106
    • GSK Investigational Site
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
  • Miskolc, Hungary, 3526
    • GSK Investigational Site
  • Pécs, Hungary, 7624
    • GSK Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • GSK Investigational Site
• India
  • Ahmedabad, India, 380015
    • GSK Investigational Site
  • Ahmedabad, India, 380052
    • GSK Investigational Site
  • Ahmedabad, India, 380054
    • GSK Investigational Site
  • Bandra, Mumbai, India, 400050
    • GSK Investigational Site
  • Bangalore, India, 560034
    • GSK Investigational Site
  • Dhantoli, Nagpur, India, 440012
    • GSK Investigational Site
  • Dhantoli, Nagpur, India
    • GSK Investigational Site
  • Jaipur, India, 302001
    • GSK Investigational Site
  • Lucknow, India, 226014
    • GSK Investigational Site
  • New Delhi, India, 110060
    • GSK Investigational Site
  • New Delhi, India, 110017
    • GSK Investigational Site
  • Pune, India, 411001
    • GSK Investigational Site
  • Pune, India, 411030
    • GSK Investigational Site
  • Secunderabad, India, 500003
    • GSK Investigational Site
  • Vadodara, India, 390015
    • GSK Investigational Site
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40133
      • GSK Investigational Site
    • Ferrara, Emilia-Romagna, Italy, 44100
      • GSK Investigational Site
  • Friuli-Venezia-Giulia
    • Udine, Friuli-Venezia-Giulia, Italy, 33100
      • GSK Investigational Site
  • Lombardia
    • Cremona, Lombardia, Italy, 26100
      • GSK Investigational Site
    • Mantova, Lombardia, Italy, 46100
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20138
      • GSK Investigational Site
    • Pavia, Lombardia, Italy, 27100
      • GSK Investigational Site
    • Rozzano (Mi), Lombardia, Italy, 20089
      • GSK Investigational Site
  • Piemonte
    • Novara, Piemonte, Italy, 28100
      • GSK Investigational Site
  • Sardegna
    • Sassari, Sardegna, Italy, 07100
      • GSK Investigational Site
  • Toscana
    • Lucca, Toscana, Italy, 55100
      • GSK Investigational Site
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • GSK Investigational Site
• Korea, Republic of
  • Busan, Korea, Republic of, 602-715
    • GSK Investigational Site
  • Daejeon, Korea, Republic of, 302-718
    • GSK Investigational Site
  • Gangnam-gu, Seoul, Korea, Republic of, 135-710
    • GSK Investigational Site
  • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-773
    • GSK Investigational Site
  • Gwangju, Korea, Republic of, 501-757
    • GSK Investigational Site
  • Gwangju, Korea, Republic of, 501-717
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 138-736
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 152-703
    • GSK Investigational Site
  • Seoul, Korea, Republic of
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 134-090
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 158-710
    • GSK Investigational Site
  • jeonju-si, Jeollabuk-Do, Korea, Republic of, 561-712
    • GSK Investigational Site
• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • GSK Investigational Site
  • Nieuwegein, Netherlands, 3435 CM
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3075 EA
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-276
    • GSK Investigational Site
  • Bytom, Poland, 41-902
    • GSK Investigational Site
  • Czestochowa, Poland, 42-200
    • GSK Investigational Site
  • Dabrowa Gornicza, Poland, 41-300
    • GSK Investigational Site
  • Gdansk, Poland, 80-952
    • GSK Investigational Site
  • Gdynia, Poland, 81-348
    • GSK Investigational Site
  • Koszalin, Poland, 75-581
    • GSK Investigational Site
  • Krakow, Poland, 31-202
    • GSK Investigational Site
  • Krakow, Poland, 31-501
    • GSK Investigational Site
  • Lubin, Poland, 59-301
    • GSK Investigational Site
  • Radom, Poland, 26-617
    • GSK Investigational Site
  • Torun, Poland, 87-100
    • GSK Investigational Site
  • Walbrzych, Poland, 58-309
    • GSK Investigational Site
  • Warszawa, Poland, 02-637
    • GSK Investigational Site
  • Warszawa, Poland, 04-073
    • GSK Investigational Site
  • Wloclawek, Poland, 87-800
    • GSK Investigational Site
  • Wroclaw, Poland, 51-124
    • GSK Investigational Site
• Russian Federation
  • Barnaul, Russian Federation, 656055
    • GSK Investigational Site
  • Kemerovo, Russian Federation, 650002
    • GSK Investigational Site
  • Krasnodar, Russian Federation, 350086
    • GSK Investigational Site
  • Moscow, Russian Federation, 111539
    • GSK Investigational Site
  • Moscow, Russian Federation, 121552
    • GSK Investigational Site
  • Moscow, Russian Federation, 109240
    • GSK Investigational Site
  • Moscow, Russian Federation, 121359
    • GSK Investigational Site
  • Novosibirsk, Russian Federation, 630055
    • GSK Investigational Site
  • Perm, Russian Federation, 614107
    • GSK Investigational Site
  • St'Petersburg, Russian Federation, 194156
    • GSK Investigational Site
  • St-Petersburg, Russian Federation, 195067
    • GSK Investigational Site
  • Tomsk, Russian Federation, 634012
    • GSK Investigational Site
  • Voronezh, Russian Federation, 394066
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150062
    • GSK Investigational Site
• Spain
  • Alicante, Spain, 03010
    • GSK Investigational Site
  • Galdakao, Spain, 48960
    • GSK Investigational Site
  • León, Spain, 24071
    • GSK Investigational Site
  • Madrid, Spain, 28047
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Malaga, Spain, 29010
    • GSK Investigational Site
  • Oviedo, Spain, 33006
    • GSK Investigational Site
  • Palma de Mallorca, Spain, 07014
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
  • Sevilla, Spain, 41014
    • GSK Investigational Site
  • Vigo/Pontevedra, Spain, 36200
    • GSK Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • GSK Investigational Site
  • Bristol, United Kingdom, BS2 8HW
    • GSK Investigational Site
  • Dundee, United Kingdom, DD1 9SY
    • GSK Investigational Site
  • Edinburgh, United Kingdom, EH16 4SA
    • GSK Investigational Site
  • Southampton, United Kingdom
    • GSK Investigational Site
  • Tooting, London, United Kingdom, SW17 0QT
    • GSK Investigational Site
• United States
  • Florida
    • Ocala, Florida, United States, 34471
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • GSK Investigational Site
  • New York
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75216
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

The following are inclusion and exclusion criteria for enrollment in the study:

Inclusion Criteria:

• Presenting or admitted to hospital with symptoms suspected to represent UA or NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of, characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitro-glycerine for relief of the pain).
• Available to be enrolled within 48 hours of the onset of the most recent episode of symptoms.
• Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
• At least two of the three following additional criteria:
• Age greater than or equal to 60 years
• Troponin T or I or CK-MB above the upper limit of normal for the local institution;
• Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation.
• Written informed consent dated and signed

Exclusion Criteria:

• Age < 21 years.
• Any contraindication to UFH or fondaparinux
• Contraindication for angiography or PCI at baseline
• Subjects requiring urgent (<120 minutes) coronary angiography as characterized by those with:
• refractory or recurrent angina associated with dynamic ST-deviation
• heart failure
• life-threatening arrhythmias
• hemodynamic instability
• Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin or UFH for treatment of the qualifying events unless the last administered (intravenous(i.v.) or s.c.) dose was:
• ≥ 8 hours for low molecular weight heparin (LMWH)
• ≥60 minutes for bivalirudin
• ≥90 minutes for unfractionated heparin (UFH)
• Hemorrhagic stroke within the last 12 months.
• Indication for anti-coagulation other than acute coronary syndrome (ACS) during the index hospitalization.
• Pregnancy or women of childbearing potential who are not using an effective method of contraception.
• Co-morbid condition with life expectancy less than 6 months.
• Currently receiving an experimental pharmacological agent.
• Revascularization procedure already performed for the qualifying event.
• Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)

Following angiography and confirmation that the subject is to undergo PCI, the subject must also meet all of the following additional criteria in order to be randomised:

• Subjects will have received at least 1 dose of open-label fondaparinux
• The most recent dose of open-label fondaparinux will not have been more than 24 hours before the start of the PCI procedure.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open label fondaparinux background and standard dose UFH; Subjects indicated for PCI and randomized to receive standard dose UFH	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.
EXPERIMENTAL: Open label fondaparinux background and low dose UFH; Subjects indicated for PCI and randomized to receive low dose UFH	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.
OTHER: Open label fondapaparinux; Subjects not indicated for PCI and not randomized	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period	The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.	Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30	The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.	Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR
Number of Participants With Major Bleeding During the Peri-PCI Period	The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.	Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Number of Participants With Minor Bleeding During the Peri-PCI Period	The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.	Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period	The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.	Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Number of Participants With Major PCI-related Procedural Complications	Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.	During PCI procedure: immediately after randomization (approximately 10-75 minutes)
Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30	The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.	Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30	The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.	Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• FUTURA/OASIS-8 Trial Group; Steg PG, Jolly SS, Mehta SR, Afzal R, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Budaj A, Diaz R, Avezum A, Widimsky P, Rao SV, Chrolavicius S, Meeks B, Joyner C, Pogue J, Yusuf S. Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial. JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.
• Ducrocq G, Jolly S, Mehta SR, Rao SV, Patel T, Moreno R, Gao P, Steg PG. Activated clotting time and outcomes during percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction: insights from the FUTURA/OASIS-8 Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002044. doi: 10.1161/CIRCINTERVENTIONS.114.002044.
• Steg PG, Mehta S, Jolly S, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Chrolavicius S, Rao SV, Granger CB, Pogue J, Laing S, Yusuf S. Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. Am Heart J. 2010 Dec;160(6):1029-34, 1034.e1. doi: 10.1016/j.ahj.2010.07.037.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (ESTIMATE): November 14, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: PCI; acute coronary syndrome; fondaparinux; Unstable angina; unfractionated heparin; Non ST elevation myocardial infarction
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Fondaparinux; PENTA
• Other Study ID Numbers: 108888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 108888
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 108888
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: 108888
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: 108888
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Annotated Case Report Form
   Information identifier: 108888
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: 108888
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 108888
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register