Last updated: 11/07/2018 02:31:52
Fondaparinux Trial with Unfractionated Heparin (UFH) during Revascularization in Acute Coronary Syndromes (ACS)FUTURA/OASIS 8
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with composite of major bleeding, minor bleeding, or major vascular access site complications during the peri-PCI period
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Secondary outcomes:
Number of participants with composite of major bleeding during the peri-PCI period, with death, MI, or TVR at Day 30
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Interventions:
Drug: fondaparinux background and standard dose UFH
Drug: Fondaparinux background and low dose heparin
Drug: Open label fondaparinux
Enrollment:
3235
Observational study model:
Not applicable
Primary completion date:
2010-11-05
Time perspective:
Not applicable
Clinical publications:
Steg PG, Diderot D, Jolly SS, et al . 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;304(12):1339-1349.
Steg PG, Diderot D, Jolly SS, et al . 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;304(12):1339-1349.
Medical condition
acute coronary syndrome
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
February 2009 to May 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
21+ years
Accepts healthy volunteers
No
- The following are inclusion and exclusion criteria for enrollment in the study:
- Inclusion Criteria:
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Bahia Blanca, Buenos Aires, Argentina, 8001
Status
Study Complete
Location
GSK Investigational Site
Santa Fe, Santa Fe, Argentina, S3000AZG
Status
Study Complete
Location
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Status
Terminated/Withdrawn
Location
GSK Investigational Site
São José do Rio Preto, São Paulo, Brazil, 15090-000
Status
Study Complete
Location
GSK Investigational Site
Rozzano (Mi), Lombardia, Italy, 20089
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Study Complete
Location
GSK Investigational Site
Birmingham, United Kingdom, B15 2TH
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gangnam-gu, Seoul, South Korea, 135-710
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Heidenheim, Baden-Wuerttemberg, Germany, 89522
Status
Study Complete
Location
GSK Investigational Site
São José do Rio Preto, São Paulo, Brazil, 15015210
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DSR
Status
Study Complete
Location
GSK Investigational Site
Montreal, Québec, Canada, H4J 1C5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53127
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Quilmes, Buenos Aires, Argentina, B1878DFK
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90620001
Status
Study Complete
Location
GSK Investigational Site
Bad Rothenfelde, Niedersachsen, Germany, 49214
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000NIL
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58452
Status
Study Complete
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41063
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, B1900AXI
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Adrogue, Buenos Aires, Argentina, B1846DSK
Status
Study Complete
Location
GSK Investigational Site
Montreal, Québec, Canada, H1T 1C8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20246
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goyang-si, Gyeonggi-do, South Korea, 411-773
Status
Study Complete
Location
GSK Investigational Site
Campina Grande do Sul, Paraná, Brazil, 83430000
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22527
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tooting, London, United Kingdom, SW17 0QT
Status
Study Complete
Location
GSK Investigational Site
Quedlinburg, Sachsen-Anhalt, Germany, 06484
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montreal, Québec, Canada, H2W 1T8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90880-480
Status
Study Complete
Location
GSK Investigational Site
Homburg, Saarland, Germany, 66421
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Usti nad Labem, Czech Republic, 400 11
Status
Study Complete
Location
GSK Investigational Site
jeonju-si, Jeollabuk-Do, South Korea, 561-712
Status
Study Complete
Location
GSK Investigational Site
Rosario, Buenos Aires, Argentina, S2000CHT
Status
Study Complete
Location
GSK Investigational Site
Merlo, Buenos Aires, Argentina, B1722COV
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41464
Status
Study Complete
Location
GSK Investigational Site
Herford, Nordrhein-Westfalen, Germany, 32049
Status
Study Complete
Location
GSK Investigational Site
Blumenau, Santa Catarina, Brazil, 89010-906
Status
Study Complete
Location
GSK Investigational Site
Simbach a. Inn, Bayern, Germany, 84359
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
Corrientes, Corrientes, Argentina, W3400AMZ
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-11-05
Actual study completion date
2010-11-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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