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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00790907
First received: November 13, 2008
Last updated: June 14, 2012
Last verified: June 2011
History of Changes
Results First Received: May 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Unstable Angina
Non ST Segment Elevation Myocardial Infarction
Interventions: Drug: fondaparinux background and standard dose UFH
Drug: Fondaparinux background and low dose heparin
Drug: Open label fondaparinux

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants (par.) received open-label (OL) fondaparinux (fond.). Par. indicated for percutaneous coronary intervention (PCI) were randomized to low- or standard-dose unfractionated heparin during PCI. Post-PCI, par. could resume OL fond. Par. not indicated for PCI weren’t randomized and continued OL fond.

Reporting Groups
  Description
Open-label Fondaparinux 2.5 mg Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
OL Fondaparinux Background + Low Dose UFH During PCI OL 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 unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OL Fondaparinux Background + Standard Dose UFH During PCI OL 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 GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on 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.

Participant Flow:   Overall Study
    Open-label Fondaparinux 2.5 mg     OL Fondaparinux Background + Low Dose UFH During PCI     OL Fondaparinux Background + Standard Dose UFH During PCI  
STARTED     1209     1024     1002  
COMPLETED     754     684     663  
NOT COMPLETED     455     340     339  
Adverse Event                 9                 7                 6  
Physician Decision                 304                 271                 255  
Withdrawal by Subject                 1                 7                 5  
Bleeding Event                 11                 16                 21  
Required Protocol-prohibited Therapy                 17                 5                 7  
Qualifying Condition Not Present                 29                 14                 16  
Verbatim Reason on the Case Report Form                 74                 20                 29  
Did Not Receive Study Drug                 10                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Open-label Fondaparinux 2.5 mg Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
OL Fondaparinux Background + Low Dose UFH During PCI OL 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 unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OL Fondaparinux Background + Standard Dose UFH During PCI OL 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 GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on 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.
Total Total of all reporting groups

Baseline Measures
    Open-label Fondaparinux 2.5 mg     OL Fondaparinux Background + Low Dose UFH During PCI     OL Fondaparinux Background + Standard Dose UFH During PCI     Total  
Number of Participants  
[units: participants]
 		  1209     1024     1002     3235  
Age  
[units: Years]
Mean ± Standard Deviation 		  65.8  ± 11.07     65.3  ± 11.25     65.5  ± 11.10     65.5  ± 11.14  
Gender  
[units: Participants]
 		       
Female     486     335     316     1137  
Male     723     689     686     2098  
Race/Ethnicity, Customized [1]
[units: participants]
 		       
South Asian     249     151     150     550  
Other Asian     63     61     61     185  
Arab     3     5     3     11  
Black African     4     1     3     8  
European     830     768     749     2347  
Native Latin     57     37     33     127  
Other - verbatim reason collected on the CRF     2     1     2     5  
Missing     1     0     1     2  
[1] CRF, case report form.



  Outcome Measures
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1.  Primary:   Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period   [ Time Frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30   [ Time Frame: 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 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Major Bleeding During the Peri-PCI Period   [ Time Frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Minor Bleeding During the Peri-PCI Period   [ Time Frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period   [ Time Frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Major PCI-related Procedural Complications   [ Time Frame: During PCI procedure: immediately after randomization (approximately 10-75 minutes) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30   [ Time Frame: 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 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30   [ Time Frame: 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 ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications of Results:
The FUTURA/OASIS-8 Trial Group. 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.

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00790907     History of Changes
Other Study ID Numbers: 108888
Study First Received: November 13, 2008
Results First Received: May 10, 2011
Last Updated: June 14, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Ministry of Health - A.N.M.A.T
Brazil: ANVISA
Russia: Russian Ministry of Health
Canada: Health Canada
India: Drugs Controlle Gerneral of India
South Korea: Food and Drug Administration
United States: Food and Drug Administration
Europe: European Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)