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)
1 other identifier
interventional
3,235
18 countries
203
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2009
203 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2008
CompletedFirst Posted
Study publicly available on registry
November 14, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
June 7, 2011
CompletedMarch 23, 2017
March 1, 2017
1.2 years
November 13, 2008
May 10, 2011
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30
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
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
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
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
During PCI procedure: immediately after randomization (approximately 10-75 minutes)
- +2 more secondary outcomes
Study Arms (3)
Open label fondaparinux background and standard dose UFH
EXPERIMENTALSubjects indicated for PCI and randomized to receive standard dose UFH
Open label fondaparinux background and low dose UFH
EXPERIMENTALSubjects indicated for PCI and randomized to receive low dose UFH
Open label fondapaparinux
OTHERSubjects not indicated for PCI and not randomized
Interventions
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.
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.
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
Eligibility Criteria
You may not qualify if:
- 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
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (203)
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Dallas, Texas, 75216, United States
GSK Investigational Site
Adrogué, Buenos Aires, B1846DSK, Argentina
GSK Investigational Site
Bahía Blanca, Buenos Aires, 8001, Argentina
GSK Investigational Site
La Plata, Buenos Aires, B1900AXI, Argentina
GSK Investigational Site
Merlo, Buenos Aires, B1722COV, Argentina
GSK Investigational Site
Quilmes, Buenos Aires, B1878CBI, Argentina
GSK Investigational Site
Quilmes, Buenos Aires, B1878DFK, Argentina
GSK Investigational Site
Rosario, Buenos Aires, S2000CHT, Argentina
GSK Investigational Site
Corrientes, Corrientes Province, W3400AMZ, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000DSR, Argentina
GSK Investigational Site
Santa Fe, Santa Fe Province, S3000AZG, Argentina
GSK Investigational Site
Santa Fe, Santa Fe Province, S3000FUJ, Argentina
GSK Investigational Site
Buenos Aires, 1428, Argentina
GSK Investigational Site
San Miguel de Tucumán, T4000NIL, Argentina
GSK Investigational Site
Campina Grande do Sul, Paraná, 83430000, Brazil
GSK Investigational Site
Curitiba, Paraná, 80320320, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90620001, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
GSK Investigational Site
Blumenau, Santa Catarina, 89010-906, Brazil
GSK Investigational Site
Campinas, São Paulo, 13059740, Brazil
GSK Investigational Site
Marília, São Paulo, 17515-900, Brazil
GSK Investigational Site
São José do Rio Preto, São Paulo, 15015210, Brazil
GSK Investigational Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
GSK Investigational Site
Plovdiv, 4002, Bulgaria
GSK Investigational Site
Sofia, 1000, Bulgaria
GSK Investigational Site
Sofia, 1309, Bulgaria
GSK Investigational Site
Sofia, 1407, Bulgaria
GSK Investigational Site
Sofia, 1709, Bulgaria
GSK Investigational Site
Calgary, Alberta, T2N 2T9, Canada
GSK Investigational Site
Hamilton, Ontario, L8L 2X2, Canada
GSK Investigational Site
London, Ontario, N6A 5A5, Canada
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Toronto, Ontario, M4N 3M5, Canada
GSK Investigational Site
Chicoutimi, Quebec, G7H 5H6, Canada
GSK Investigational Site
Montreal, Quebec, H1T 1C8, Canada
GSK Investigational Site
Montreal, Quebec, H2W 1T8, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G5, Canada
GSK Investigational Site
Brno, 656 91, Czechia
GSK Investigational Site
Hradec Králové, 500 05, Czechia
GSK Investigational Site
Karlovy Vary, 360 66, Czechia
GSK Investigational Site
Pilsen, 304 60, Czechia
GSK Investigational Site
Prague, 100 34, Czechia
GSK Investigational Site
Prague, 128 00, Czechia
GSK Investigational Site
Prague, 150 06, Czechia
GSK Investigational Site
Ústí nad Labem, 400 11, Czechia
GSK Investigational Site
Zlín, 762 75, Czechia
GSK Investigational Site
Besançon, 25030, France
GSK Investigational Site
Caen, 14033, France
GSK Investigational Site
Créteil, 94010, France
GSK Investigational Site
Dijon, 21079, France
GSK Investigational Site
Marseille, 13385, France
GSK Investigational Site
Montfermeil, 93370, France
GSK Investigational Site
Paris, 75877, France
GSK Investigational Site
Rouen, 76031, France
GSK Investigational Site
Toulouse, 31059, France
GSK Investigational Site
Tours, 37044, France
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Heidenheim, Baden-Wurttemberg, 89522, Germany
GSK Investigational Site
Bad Tölz, Bavaria, 83646, Germany
GSK Investigational Site
Dachau, Bavaria, 85221, Germany
GSK Investigational Site
Erlangen, Bavaria, 91054, Germany
GSK Investigational Site
Simbach A. Inn, Bavaria, 84359, Germany
GSK Investigational Site
Bernau bei Berlin, Brandenburg, 16321, Germany
GSK Investigational Site
Cottbus, Brandenburg, 03048, Germany
GSK Investigational Site
Bremen, City state Bremen, 28277, Germany
GSK Investigational Site
Hamburg, Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, Hamburg, 22527, Germany
GSK Investigational Site
Kassel, Hesse, 34121, Germany
GSK Investigational Site
Langen, Hesse, 63225, Germany
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428, Germany
GSK Investigational Site
Bad Rothenfelde, Lower Saxony, 49214, Germany
GSK Investigational Site
Göttingen, Lower Saxony, 37075, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18057, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937, Germany
GSK Investigational Site
Herford, North Rhine-Westphalia, 32049, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41464, Germany
GSK Investigational Site
Witten, North Rhine-Westphalia, 58452, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Homburg, Saarland, 66421, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Leipzig, Saxony, 04289, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06120, Germany
GSK Investigational Site
Quedlinburg, Saxony-Anhalt, 06484, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23538, Germany
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534, Germany
GSK Investigational Site
Berlin, State of Berlin, 10249, Germany
GSK Investigational Site
Berlin, State of Berlin, 12683, Germany
GSK Investigational Site
Berlin, State of Berlin, 13353, Germany
GSK Investigational Site
Erfurt, Thuringia, 99089, Germany
GSK Investigational Site
Athens, 115 26, Greece
GSK Investigational Site
Athens, 115 27, Greece
GSK Investigational Site
Athens, 124 62, Greece
GSK Investigational Site
Athens, 151 27, Greece
GSK Investigational Site
Athens, 176 74, Greece
GSK Investigational Site
Ioannina, 45 500, Greece
GSK Investigational Site
Rio- Patras, 26 504, Greece
GSK Investigational Site
Balatonfüred, 8230, Hungary
GSK Investigational Site
Budapest, 1096, Hungary
GSK Investigational Site
Budapest, 1106, Hungary
GSK Investigational Site
Budapest, 1122, Hungary
GSK Investigational Site
Debrecen, 4032, Hungary
GSK Investigational Site
Miskolc, 3526, Hungary
GSK Investigational Site
Pécs, 7624, Hungary
GSK Investigational Site
Zalaegerszeg, 8900, Hungary
GSK Investigational Site
Ahmedabad, 380015, India
GSK Investigational Site
Ahmedabad, 380052, India
GSK Investigational Site
Ahmedabad, 380054, India
GSK Investigational Site
Bandra, Mumbai, 400050, India
GSK Investigational Site
Bangalore, 560034, India
GSK Investigational Site
Dhantoli, Nagpur, 440012, India
GSK Investigational Site
Dhantoli, Nagpur, India
GSK Investigational Site
Jaipur, 302001, India
GSK Investigational Site
Lucknow, 226014, India
GSK Investigational Site
New Delhi, 110017, India
GSK Investigational Site
New Delhi, 110060, India
GSK Investigational Site
Pune, 411001, India
GSK Investigational Site
Pune, 411030, India
GSK Investigational Site
Secunderabad, 500003, India
GSK Investigational Site
Vadodara, 390015, India
GSK Investigational Site
Bologna, Emilia-Romagna, 40133, Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100, Italy
GSK Investigational Site
Udine, Friuli Venezia Giulia, 33100, Italy
GSK Investigational Site
Cremona, Lombardy, 26100, Italy
GSK Investigational Site
Mantova, Lombardy, 46100, Italy
GSK Investigational Site
Milan, Lombardy, 20138, Italy
GSK Investigational Site
Pavia, Lombardy, 27100, Italy
GSK Investigational Site
Rozzano (Mi), Lombardy, 20089, Italy
GSK Investigational Site
Novara, Piedmont, 28100, Italy
GSK Investigational Site
Sassari, Sardinia, 07100, Italy
GSK Investigational Site
Lucca, Tuscany, 55100, Italy
GSK Investigational Site
Perugia, Umbria, 06156, Italy
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Nieuwegein, 3435 CM, Netherlands
GSK Investigational Site
Rotterdam, 3075 EA, Netherlands
GSK Investigational Site
Bialystok, 15-276, Poland
GSK Investigational Site
Bytom, 41-902, Poland
GSK Investigational Site
Częstochowa, 42-200, Poland
GSK Investigational Site
Dąbrowa Górnicza, 41-300, Poland
GSK Investigational Site
Gdansk, 80-952, Poland
GSK Investigational Site
Gdynia, 81-348, Poland
GSK Investigational Site
Koszalin, 75-581, Poland
GSK Investigational Site
Krakow, 31-202, Poland
GSK Investigational Site
Krakow, 31-501, Poland
GSK Investigational Site
Lubin, 59-301, Poland
GSK Investigational Site
Radom, 26-617, Poland
GSK Investigational Site
Torun, 87-100, Poland
GSK Investigational Site
Warsaw, 02-637, Poland
GSK Investigational Site
Warsaw, 04-073, Poland
GSK Investigational Site
Wałbrzych, 58-309, Poland
GSK Investigational Site
Wroclaw, 51-124, Poland
GSK Investigational Site
Włocławek, 87-800, Poland
GSK Investigational Site
Barnaul, 656055, Russia
GSK Investigational Site
Kemerovo, 650002, Russia
GSK Investigational Site
Krasnodar, 350086, Russia
GSK Investigational Site
Moscow, 109240, Russia
GSK Investigational Site
Moscow, 111539, Russia
GSK Investigational Site
Moscow, 121359, Russia
GSK Investigational Site
Moscow, 121552, Russia
GSK Investigational Site
Novosibirsk, 630055, Russia
GSK Investigational Site
Perm, 614107, Russia
GSK Investigational Site
Saint Petersburg, 195067, Russia
GSK Investigational Site
St'Petersburg, 194156, Russia
GSK Investigational Site
Tomsk, 634012, Russia
GSK Investigational Site
Voronezh, 394066, Russia
GSK Investigational Site
Yaroslavl, 150062, Russia
GSK Investigational Site
Busan, 602-715, South Korea
GSK Investigational Site
Daejeon, 302-718, South Korea
GSK Investigational Site
Gangnam-gu, Seoul, 135-710, South Korea
GSK Investigational Site
Goyang-si, Gyeonggi-do, 411-773, South Korea
GSK Investigational Site
Gwangju, 501-717, South Korea
GSK Investigational Site
Gwangju, 501-757, South Korea
GSK Investigational Site
Gyeonggi-do, South Korea
GSK Investigational Site
Jeonju-si, Jeollabuk-Do, 561-712, South Korea
GSK Investigational Site
Seoul, 134-090, South Korea
GSK Investigational Site
Seoul, 138-736, South Korea
GSK Investigational Site
Seoul, 152-703, South Korea
GSK Investigational Site
Seoul, 158-710, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Alicante, 03010, Spain
GSK Investigational Site
Galdakao, 48960, Spain
GSK Investigational Site
León, 24071, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Madrid, 28047, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Oviedo, 33006, Spain
GSK Investigational Site
Palma de Mallorca, 07014, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41014, Spain
GSK Investigational Site
Vigo/Pontevedra, 36200, Spain
GSK Investigational Site
Birmingham, B15 2TH, United Kingdom
GSK Investigational Site
Bristol, BS2 8HW, United Kingdom
GSK Investigational Site
Dundee, DD1 9SY, United Kingdom
GSK Investigational Site
Edinburgh, EH16 4SA, United Kingdom
GSK Investigational Site
Southampton, United Kingdom
GSK Investigational Site
Tooting, London, SW17 0QT, United Kingdom
Related Publications (3)
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.
PMID: 20805623BACKGROUNDDucrocq 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.
PMID: 25873729DERIVEDSteg 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.
PMID: 21146654DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2008
First Posted
November 14, 2008
Study Start
February 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
March 23, 2017
Results First Posted
June 7, 2011
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.