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

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ClinicalTrials.gov Identifier: NCT00790907
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : June 7, 2011
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Coronary Syndrome
Interventions Drug: fondaparinux background and standard dose UFH
Drug: Fondaparinux background and low dose heparin
Drug: Open label fondaparinux
Enrollment 3235
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Open-label Fondaparinux 2.5 mg OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description 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 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 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.
Period Title: Overall Study
Started 1209 1024 1002
Completed 754 684 663
Not Completed 455 340 339
Reason Not Completed
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
Arm/Group Title Open-label Fondaparinux 2.5 mg OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI Total
Hide Arm/Group Description 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 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 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 of all reporting groups
Overall Number of Baseline Participants 1209 1024 1002 3235
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1209 participants 1024 participants 1002 participants 3235 participants
65.8  (11.07) 65.3  (11.25) 65.5  (11.10) 65.5  (11.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1209 participants 1024 participants 1002 participants 3235 participants
Female
486
  40.2%
335
  32.7%
316
  31.5%
1137
  35.1%
Male
723
  59.8%
689
  67.3%
686
  68.5%
2098
  64.9%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1209 participants 1024 participants 1002 participants 3235 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]
Measure Description: CRF, case report form.
1.Primary Outcome
Title Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period
Hide Description 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.
Time Frame Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
48 58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OL Fondaparinux Background + Low Dose UFH During PCI, OL Fondaparinux Background + Standard Dose UFH During PCI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.54 to 1.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
59 39
3.Secondary Outcome
Title Number of Participants With Major Bleeding During the Peri-PCI Period
Hide Description 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.
Time Frame Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
14 12
4.Secondary Outcome
Title Number of Participants With Minor Bleeding During the Peri-PCI Period
Hide Description 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.
Time Frame Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
7 17
5.Secondary Outcome
Title Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period
Hide Description 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.
Time Frame Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
33 43
6.Secondary Outcome
Title Number of Participants With Major PCI-related Procedural Complications
Hide Description 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.
Time Frame During PCI procedure: immediately after randomization (approximately 10-75 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
Abrupt Vessel Closure 10 17
New Angiographic Thrombus 11 8
Suspected Catheter-related Thrombus 4 3
Catheter-related Thrombus-Adjudicated 4 1
No-reflow Phenomenon 20 22
New Major Dissection with Reduced Flow 10 10
7.Secondary Outcome
Title Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
Composite of death, MI, and TVR Peri-PCI 23 19
Composite of death, MI, and TVR at Day 30 46 29
8.Secondary Outcome
Title Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 1024 1002
Measure Type: Number
Unit of Measure: participants
Death during peri-PCI period 1 2
MI during peri-PCI period 20 16
TVR during peri-PCI period 3 2
Definite/Probable Stent Thrombosis during peri-PCI 1 2
Stroke during peri-PCI 3 5
Death at Day 30 8 6
MI at Day 30 31 25
TVR at Day 30 9 3
Definite/Probable Stent Thrombosis at Day 30 12 5
Stroke at Day 30 5 5
Time Frame Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of fondaparinux until the follow-up at 30 days after randomization or angiography.
Adverse Event Reporting Description Per the protocol, study outcome events (including bleeding, death, myocardial infarction [MI] and stroke, and other disease-related events) were not to be reported as AEs/SAEs.
 
Arm/Group Title Open-label Fondaparinux 2.5 mg OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Hide Arm/Group Description 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 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 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.
All-Cause Mortality
Open-label Fondaparinux 2.5 mg OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Open-label Fondaparinux 2.5 mg OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/1209 (3.97%)   28/1024 (2.73%)   20/1002 (2.00%) 
Blood and lymphatic system disorders       
Anemia of chronic disease  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Hemolytic anemia  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Cardiac disorders       
Atrial thrombosis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Pericardial effusion  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Cardiac tamponade  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Gastrointestinal disorders       
Colitis ischaemic  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Enterocolitis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Intestinal ischemia  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Esophagitis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Abdominal pain  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Fecaloma  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Esophageal spasm  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
General disorders       
Impaired healing  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Non-cardiac chest pain  1  1/1209 (0.08%)  1/1024 (0.10%)  2/1002 (0.20%) 
Hepatobiliary disorders       
Cholangitis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Cholecystitis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Infections and infestations       
Pneumonia  1  4/1209 (0.33%)  2/1024 (0.20%)  2/1002 (0.20%) 
Septic shock  1  2/1209 (0.17%)  0/1024 (0.00%)  0/1002 (0.00%) 
Anal abscess  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Gastroenteritis viral  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Lower respiratory tract infection  1  1/1209 (0.08%)  0/1024 (0.00%)  1/1002 (0.10%) 
Post procedural infection  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Sepsis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Arthritis bacterial  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Bronchopneumonia  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Cellulitis  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Cholecystitis infective  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Pyelonephritis acute  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Urosepsis  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Injury, poisoning and procedural complications       
Postoperative wound infection  1  3/1209 (0.25%)  0/1024 (0.00%)  0/1002 (0.00%) 
Contrast media reaction  1  1/1209 (0.08%)  0/1024 (0.00%)  1/1002 (0.10%) 
Postoperative wound complication  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Vascular access complication  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Vascular pseudoaneurysm  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Investigations       
Hepatic enzyme increased  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Platelet count decreased  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Metabolism and nutrition disorders       
Acidosis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Brain neoplasm  1  2/1209 (0.17%)  0/1024 (0.00%)  0/1002 (0.00%) 
Gastric cancer  1  1/1209 (0.08%)  1/1024 (0.10%)  0/1002 (0.00%) 
Hepatic neoplasm  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Lung adenocarcinoma  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Multiple myeloma  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Esophageal adenocarcinoma  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Colon cancer  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Neoplasm prostate  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Pancreatic carcinoma metastatic  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Nervous system disorders       
Transient ischemic attack  1  2/1209 (0.17%)  0/1024 (0.00%)  0/1002 (0.00%) 
Hepatic encephalophathy  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Vascular encephalopathy  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Renal and urinary disorders       
Renal failure acute  1  3/1209 (0.25%)  3/1024 (0.29%)  0/1002 (0.00%) 
Nephropathy toxic  1  2/1209 (0.17%)  6/1024 (0.59%)  2/1002 (0.20%) 
Renal artery stenosis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Renal failure  1  1/1209 (0.08%)  0/1024 (0.00%)  3/1002 (0.30%) 
Urethral stenosis  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumothorax  1  2/1209 (0.17%)  0/1024 (0.00%)  0/1002 (0.00%) 
Pulmonary embolism  1  2/1209 (0.17%)  1/1024 (0.10%)  1/1002 (0.10%) 
Pulmonary edema  1  2/1209 (0.17%)  0/1024 (0.00%)  0/1002 (0.00%) 
Respiratory depression  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Respiratory failure  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Chronic obstructive pulmonary disease  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Pleural hemorrhage  1  0/1209 (0.00%)  0/1024 (0.00%)  1/1002 (0.10%) 
Vascular disorders       
Aortic dissection  1  1/1209 (0.08%)  1/1024 (0.10%)  1/1002 (0.10%) 
Deep vein thrombosis  1  1/1209 (0.08%)  1/1024 (0.10%)  0/1002 (0.00%) 
Extremity necrosis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Thrombophlebitis  1  1/1209 (0.08%)  0/1024 (0.00%)  0/1002 (0.00%) 
Hypertension  1  0/1209 (0.00%)  1/1024 (0.10%)  0/1002 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Open-label Fondaparinux 2.5 mg OL Fondaparinux Background + Low Dose UFH During PCI OL Fondaparinux Background + Standard Dose UFH During PCI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   117/1209 (9.68%)   100/1024 (9.77%)   113/1002 (11.28%) 
Gastrointestinal disorders       
Gastritis  1  15/1209 (1.24%)  0/1024 (0.00%)  2/1002 (0.20%) 
Constipation  1  10/1209 (0.83%)  5/1024 (0.49%)  8/1002 (0.80%) 
Nausea  1  7/1209 (0.58%)  4/1024 (0.39%)  5/1002 (0.50%) 
Vomiting  1  6/1209 (0.50%)  9/1024 (0.88%)  5/1002 (0.50%) 
Diarrhea  1  1/1209 (0.08%)  9/1024 (0.88%)  7/1002 (0.70%) 
General disorders       
Asthenia  1  13/1209 (1.08%)  7/1024 (0.68%)  3/1002 (0.30%) 
Pyrexia  1  13/1209 (1.08%)  11/1024 (1.07%)  16/1002 (1.60%) 
Non-cardiac chest pain  1  4/1209 (0.33%)  1/1024 (0.10%)  6/1002 (0.60%) 
Infections and infestations       
Urinary tract infection  1  15/1209 (1.24%)  5/1024 (0.49%)  5/1002 (0.50%) 
Nasopharyngitis  1  1/1209 (0.08%)  2/1024 (0.20%)  7/1002 (0.70%) 
Injury, poisoning and procedural complications       
Post procedural discharge  1  11/1209 (0.91%)  9/1024 (0.88%)  15/1002 (1.50%) 
Metabolism and nutrition disorders       
Hypercholesterolemia  1  7/1209 (0.58%)  3/1024 (0.29%)  5/1002 (0.50%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  8/1209 (0.66%)  7/1024 (0.68%)  1/1002 (0.10%) 
Nervous system disorders       
Headache  1  18/1209 (1.49%)  24/1024 (2.34%)  28/1002 (2.79%) 
Carotid artery stenosis  1  7/1209 (0.58%)  7/1024 (0.68%)  4/1002 (0.40%) 
Dizziness  1  5/1209 (0.41%)  11/1024 (1.07%)  2/1002 (0.20%) 
Psychiatric disorders       
Insomnia  1  2/1209 (0.17%)  6/1024 (0.59%)  2/1002 (0.20%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  8/1209 (0.66%)  6/1024 (0.59%)  3/1002 (0.30%) 
Cough  1  3/1209 (0.25%)  4/1024 (0.39%)  10/1002 (1.00%) 
Vascular disorders       
Hypotension  1  7/1209 (0.58%)  6/1024 (0.59%)  10/1002 (1.00%) 
Hematoma  1  2/1209 (0.17%)  6/1024 (0.59%)  3/1002 (0.30%) 
Hypertension  1  2/1209 (0.17%)  0/1024 (0.00%)  7/1002 (0.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00790907    
Other Study ID Numbers: 108888
First Submitted: November 13, 2008
First Posted: November 14, 2008
Results First Submitted: May 10, 2011
Results First Posted: June 7, 2011
Last Update Posted: March 23, 2017