Trial Outcomes & Findings for Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (NCT NCT00790907)

Last Updated: 2017-03-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

3235 participants

Primary outcome timeframe

Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Results posted on

2017-03-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1209	1024	1002
Overall Study COMPLETED	754	684	663
Overall Study NOT COMPLETED	455	340	339

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	9	7	6
Overall Study Physician Decision	304	271	255
Overall Study Withdrawal by Subject	1	7	5
Overall Study Bleeding Event	11	16	21
Overall Study Required Protocol-prohibited Therapy	17	5	7
Overall Study Qualifying Condition Not Present	29	14	16
Overall Study Verbatim Reason on the Case Report Form	74	20	29
Overall Study Did Not Receive Study Drug	10	0	0

Baseline Characteristics

Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Fondaparinux 2.5 mg n=1209 Participants 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 n=1024 Participants 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 n=1002 Participants 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 n=3235 Participants Total of all reporting groups
Age, Continuous	65.8 Years STANDARD_DEVIATION 11.07 • n=93 Participants	65.3 Years STANDARD_DEVIATION 11.25 • n=4 Participants	65.5 Years STANDARD_DEVIATION 11.10 • n=27 Participants	65.5 Years STANDARD_DEVIATION 11.14 • n=483 Participants
Sex: Female, Male Female	486 Participants n=93 Participants	335 Participants n=4 Participants	316 Participants n=27 Participants	1137 Participants n=483 Participants
Sex: Female, Male Male	723 Participants n=93 Participants	689 Participants n=4 Participants	686 Participants n=27 Participants	2098 Participants n=483 Participants
Race/Ethnicity, Customized South Asian	249 participants n=93 Participants	151 participants n=4 Participants	150 participants n=27 Participants	550 participants n=483 Participants
Race/Ethnicity, Customized Other Asian	63 participants n=93 Participants	61 participants n=4 Participants	61 participants n=27 Participants	185 participants n=483 Participants
Race/Ethnicity, Customized Arab	3 participants n=93 Participants	5 participants n=4 Participants	3 participants n=27 Participants	11 participants n=483 Participants
Race/Ethnicity, Customized Black African	4 participants n=93 Participants	1 participants n=4 Participants	3 participants n=27 Participants	8 participants n=483 Participants
Race/Ethnicity, Customized European	830 participants n=93 Participants	768 participants n=4 Participants	749 participants n=27 Participants	2347 participants n=483 Participants
Race/Ethnicity, Customized Native Latin	57 participants n=93 Participants	37 participants n=4 Participants	33 participants n=27 Participants	127 participants n=483 Participants
Race/Ethnicity, Customized Other - verbatim reason collected on the CRF	2 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants	5 participants n=483 Participants
Race/Ethnicity, Customized Missing	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants	2 participants n=483 Participants

PRIMARY outcome

Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Population: Intent-to-Treat (ITT) Population: all randomized participants

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period	48 participants	58 participants

SECONDARY outcome

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

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30	59 participants	39 participants

SECONDARY outcome

Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants With Major Bleeding During the Peri-PCI Period	14 participants	12 participants

SECONDARY outcome

Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants With Minor Bleeding During the Peri-PCI Period	7 participants	17 participants

SECONDARY outcome

Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period	33 participants	43 participants

SECONDARY outcome

Timeframe: During PCI procedure: immediately after randomization (approximately 10-75 minutes)

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants With Major PCI-related Procedural Complications New Major Dissection with Reduced Flow	10 participants	10 participants
Number of Participants With Major PCI-related Procedural Complications Abrupt Vessel Closure	10 participants	17 participants
Number of Participants With Major PCI-related Procedural Complications New Angiographic Thrombus	11 participants	8 participants
Number of Participants With Major PCI-related Procedural Complications Suspected Catheter-related Thrombus	4 participants	3 participants
Number of Participants With Major PCI-related Procedural Complications Catheter-related Thrombus-Adjudicated	4 participants	1 participants
Number of Participants With Major PCI-related Procedural Complications No-reflow Phenomenon	20 participants	22 participants

SECONDARY outcome

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

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 Composite of death, MI, and TVR at Day 30	46 participants	29 participants
Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 Composite of death, MI, and TVR Peri-PCI	23 participants	19 participants

SECONDARY outcome

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

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	OL Fondaparinux Background + Low Dose UFH During PCI n=1024 Participants 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 n=1002 Participants 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.
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 Definite/Probable Stent Thrombosis at Day 30	12 participants	5 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 Stroke at Day 30	5 participants	5 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 Death during peri-PCI period	1 participants	2 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 MI during peri-PCI period	20 participants	16 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 TVR during peri-PCI period	3 participants	2 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 Definite/Probable Stent Thrombosis during peri-PCI	1 participants	2 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 Stroke during peri-PCI	3 participants	5 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 Death at Day 30	8 participants	6 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 MI at Day 30	31 participants	25 participants
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 TVR at Day 30	9 participants	3 participants

Adverse Events

Open-label Fondaparinux 2.5 mg

Serious events: 48 serious events

Other events: 117 other events

Deaths: 0 deaths

OL Fondaparinux Background + Low Dose UFH During PCI

Serious events: 28 serious events

Other events: 100 other events

Deaths: 0 deaths

OL Fondaparinux Background + Standard Dose UFH During PCI

Serious events: 20 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER