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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

fondaparinux background and standard dose UFH

Fondaparinux background and low dose heparin

Open label fondaparinux

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Unstable angina, Non ST elevation myocardial infarction, PCI, unfractionated heparin, fondaparinux, acute coronary syndrome

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Open label fondaparinux background and standard dose UFH

Open label fondaparinux background and low dose UFH

Open label fondapaparinux

Arm Description

Subjects indicated for PCI and randomized to receive standard dose UFH

Subjects indicated for PCI and randomized to receive low dose UFH

Subjects not indicated for PCI and not randomized

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30

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.

Number of Participants With Major Bleeding During the Peri-PCI Period

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.

Number of Participants With Minor Bleeding During the Peri-PCI Period

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.

Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period

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.

Number of Participants With Major PCI-related Procedural Complications

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.

Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30

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.

Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30

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.

Full Information

NCT ID

NCT00790907

First Posted

November 13, 2008

Last Updated

March 21, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00790907

Brief Title

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

Acronym

FUTURA/OASIS 8

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo angiography (ideally within 72 hours) will be assessed for eligibility and consented. Suitable subjects will be enrolled and commence treatment with open-label fondaparinux, 2.5 milligram (mg), subcutaneous (s.c.), once daily. Following angiography subjects indicated for PCI and meeting the additional requirements for randomization will be randomised to receive one of two dose regimens of UFH either standard dose or low dose immediately prior to the PCI procedure. Post-PCI, therapy with fondaparinux (2.5 mg, s.c.) may be resumed at the investigator's discretion for up to a maximum of 8 days or hospital discharge, whichever is earlier. Subjects not indicated for PCI, will continue treatment with fondaparinux, 2.5mg, s.c, once daily for up to 8 days or hospital discharge, whichever is earlier. All subjects will be followed up for 30 days after randomization/angiography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Unstable angina, Non ST elevation myocardial infarction, PCI, unfractionated heparin, fondaparinux, acute coronary syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3235 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label fondaparinux background and standard dose UFH

Arm Type

Experimental

Arm Description

Subjects indicated for PCI and randomized to receive standard dose UFH

Arm Title

Open label fondaparinux background and low dose UFH

Arm Type

Experimental

Arm Description

Subjects indicated for PCI and randomized to receive low dose UFH

Arm Title

Open label fondapaparinux

Arm Type

Other

Arm Description

Subjects not indicated for PCI and not randomized

Intervention Type

Drug

Intervention Name(s)

fondaparinux background and standard dose UFH

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Fondaparinux background and low dose heparin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Open label fondaparinux

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30

Description

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

Title

Number of Participants With Major Bleeding During the Peri-PCI Period

Description

Time Frame

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

Title

Number of Participants With Minor Bleeding During the Peri-PCI Period

Description

Time Frame

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

Title

Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period

Description

Time Frame

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

Title

Number of Participants With Major PCI-related Procedural Complications

Description

Time Frame

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

Title

Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30

Description

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

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

GSK Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

GSK Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

GSK Investigational Site

City

Adrogue

State/Province

Buenos Aires

ZIP/Postal Code

B1846DSK

Country

Argentina

Facility Name

GSK Investigational Site

City

Bahia Blanca

State/Province

Buenos Aires

ZIP/Postal Code

8001

Country

Argentina

Facility Name

GSK Investigational Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1900AXI

Country

Argentina

Facility Name

GSK Investigational Site

City

Merlo

State/Province

Buenos Aires

ZIP/Postal Code

B1722COV

Country

Argentina

Facility Name

GSK Investigational Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878CBI

Country

Argentina

Facility Name

GSK Investigational Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878DFK

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Buenos Aires

ZIP/Postal Code

S2000CHT

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSR

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1428

Country

Argentina

Facility Name

GSK Investigational Site

City

Corrientes

ZIP/Postal Code

W3400AMZ

Country

Argentina

Facility Name

GSK Investigational Site

City

San Miguel de Tucumán

ZIP/Postal Code

T4000NIL

Country

Argentina

Facility Name

GSK Investigational Site

City

Santa Fe

ZIP/Postal Code

S3000AZG

Country

Argentina

Facility Name

GSK Investigational Site

City

Santa Fe

ZIP/Postal Code

S3000FUJ

Country

Argentina

Facility Name

GSK Investigational Site

City

Campina Grande do Sul

State/Province

Paraná

ZIP/Postal Code

83430000

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80320320

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90620001

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90880-480

Country

Brazil

Facility Name

GSK Investigational Site

City

Blumenau

State/Province

Santa Catarina

ZIP/Postal Code

89010-906

Country

Brazil

Facility Name

GSK Investigational Site

City

Campinas

State/Province

São Paulo

ZIP/Postal Code

13059740

Country

Brazil

Facility Name

GSK Investigational Site

City

Marília

State/Province

São Paulo

ZIP/Postal Code

17515-900

Country

Brazil

Facility Name

GSK Investigational Site

City

São José do Rio Preto

State/Province

São Paulo

ZIP/Postal Code

15015210

Country

Brazil

Facility Name

GSK Investigational Site

City

São José do Rio Preto

State/Province

São Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

GSK Investigational Site

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 5H6

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Karlovy Vary

ZIP/Postal Code

360 66

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Plzen

ZIP/Postal Code

304 60

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Praha 2

ZIP/Postal Code

128 00

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Usti nad Labem

ZIP/Postal Code

400 11

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Zlin

ZIP/Postal Code

762 75

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Besançon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

GSK Investigational Site

City

Caen Cedex 9

ZIP/Postal Code

14033

Country

France

Facility Name

GSK Investigational Site

City

Créteil

ZIP/Postal Code

94010

Country

France

Facility Name

GSK Investigational Site

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

GSK Investigational Site

City

Marseille Cedex 05

ZIP/Postal Code

13385

Country

France

Facility Name

GSK Investigational Site

City

Montfermeil

ZIP/Postal Code

93370

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

GSK Investigational Site

City

Rouen Cedex

ZIP/Postal Code

76031

Country

France

Facility Name

GSK Investigational Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

GSK Investigational Site

City

Tours cedex 09

ZIP/Postal Code

37044

Country

France

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

GSK Investigational Site

City

Heidenheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89522

Country

Germany

Facility Name

GSK Investigational Site

City

Bad Toelz

State/Province

Bayern

ZIP/Postal Code

83646

Country

Germany

Facility Name

GSK Investigational Site

City

Dachau

State/Province

Bayern

ZIP/Postal Code

85221

Country

Germany

Facility Name

GSK Investigational Site

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91054

Country

Germany

Facility Name

GSK Investigational Site

City

Simbach a. Inn

State/Province

Bayern

ZIP/Postal Code

84359

Country

Germany

Facility Name

GSK Investigational Site

City

Bernau

State/Province

Brandenburg

ZIP/Postal Code

16321

Country

Germany

Facility Name

GSK Investigational Site

City

Cottbus

State/Province

Brandenburg

ZIP/Postal Code

03048

Country

Germany

Facility Name

GSK Investigational Site

City

Kassel

State/Province

Hessen

ZIP/Postal Code

34121

Country

Germany

Facility Name

GSK Investigational Site

City

Langen

State/Province

Hessen

ZIP/Postal Code

63225

Country

Germany

Facility Name

GSK Investigational Site

City

Ruesselsheim

State/Province

Hessen

ZIP/Postal Code

65428

Country

Germany

Facility Name

GSK Investigational Site

City

Rostock

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

18057

Country

Germany

Facility Name

GSK Investigational Site

City

Bad Rothenfelde

State/Province

Niedersachsen

ZIP/Postal Code

49214

Country

Germany

Facility Name

GSK Investigational Site

City

Goettingen

State/Province

Niedersachsen

ZIP/Postal Code

37075

Country

Germany

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

GSK Investigational Site

City

Herford

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

32049

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

GSK Investigational Site

City

Moenchengladbach

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41063

Country

Germany

Facility Name

GSK Investigational Site

City

Neuss

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41464

Country

Germany

Facility Name

GSK Investigational Site

City

Witten

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58452

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Homburg

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Facility Name

GSK Investigational Site

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06120

Country

Germany

Facility Name

GSK Investigational Site

City

Quedlinburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06484

Country

Germany

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04289

Country

Germany

Facility Name

GSK Investigational Site

City

Luebeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

Facility Name

GSK Investigational Site

City

Neumuenster

State/Province

Schleswig-Holstein

ZIP/Postal Code

24534

Country

Germany

Facility Name

GSK Investigational Site

City

Erfurt

State/Province

Thueringen

ZIP/Postal Code

99089

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10249

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12683

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

GSK Investigational Site

City

Bremen

ZIP/Postal Code

28277

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22527

Country

Germany

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 26

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

124 62

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

151 27

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

176 74

Country

Greece

Facility Name

GSK Investigational Site

City

Ioannina

ZIP/Postal Code

45 500

Country

Greece

Facility Name

GSK Investigational Site

City

Rio- Patras

ZIP/Postal Code

26 504

Country

Greece

Facility Name

GSK Investigational Site

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1096

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

GSK Investigational Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

GSK Investigational Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

GSK Investigational Site

City

Pécs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

GSK Investigational Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

GSK Investigational Site

City

Ahmedabad

ZIP/Postal Code

380015

Country

India

Facility Name

GSK Investigational Site

City

Ahmedabad

ZIP/Postal Code

380052

Country

India

Facility Name

GSK Investigational Site

City

Ahmedabad

ZIP/Postal Code

380054

Country

India

Facility Name

GSK Investigational Site

City

Bandra, Mumbai

ZIP/Postal Code

400050

Country

India

Facility Name

GSK Investigational Site

City

Bangalore

ZIP/Postal Code

560034

Country

India

Facility Name

GSK Investigational Site

City

Dhantoli, Nagpur

ZIP/Postal Code

440012

Country

India

Facility Name

GSK Investigational Site

City

Dhantoli, Nagpur

Country

India

Facility Name

GSK Investigational Site

City

Jaipur

ZIP/Postal Code

302001

Country

India

Facility Name

GSK Investigational Site

City

Lucknow

ZIP/Postal Code

226014

Country

India

Facility Name

GSK Investigational Site

City

New Delhi

ZIP/Postal Code

110017

Country

India

Facility Name

GSK Investigational Site

City

New Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

GSK Investigational Site

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

GSK Investigational Site

City

Pune

ZIP/Postal Code

411030

Country

India

Facility Name

GSK Investigational Site

City

Secunderabad

ZIP/Postal Code

500003

Country

India

Facility Name

GSK Investigational Site

City

Vadodara

ZIP/Postal Code

390015

Country

India

Facility Name

GSK Investigational Site

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40133

Country

Italy

Facility Name

GSK Investigational Site

City

Ferrara

State/Province

Emilia-Romagna

ZIP/Postal Code

44100

Country

Italy

Facility Name

GSK Investigational Site

City

Udine

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

GSK Investigational Site

City

Cremona

State/Province

Lombardia

ZIP/Postal Code

26100

Country

Italy

Facility Name

GSK Investigational Site

City

Mantova

State/Province

Lombardia

ZIP/Postal Code

46100

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20138

Country

Italy

Facility Name

GSK Investigational Site

City

Pavia

State/Province

Lombardia

ZIP/Postal Code

27100

Country

Italy

Facility Name

GSK Investigational Site

City

Rozzano (Mi)

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

GSK Investigational Site

City

Novara

State/Province

Piemonte

ZIP/Postal Code

28100

Country

Italy

Facility Name

GSK Investigational Site

City

Sassari

State/Province

Sardegna

ZIP/Postal Code

07100

Country

Italy

Facility Name

GSK Investigational Site

City

Lucca

State/Province

Toscana

ZIP/Postal Code

55100

Country

Italy

Facility Name

GSK Investigational Site

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06156

Country

Italy

Facility Name

GSK Investigational Site

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daejeon

ZIP/Postal Code

302-718

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gangnam-gu, Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Goyang-si, Gyeonggi-do

ZIP/Postal Code

411-773

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gwangju

ZIP/Postal Code

501-717

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gyeonggi-do

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

jeonju-si, Jeollabuk-Do

ZIP/Postal Code

561-712

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

134-090

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

158-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

GSK Investigational Site

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

GSK Investigational Site

City

Czestochowa

ZIP/Postal Code

42-200

Country

Poland

Facility Name

GSK Investigational Site

City

Dabrowa Gornicza

ZIP/Postal Code

41-300

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

GSK Investigational Site

City

Gdynia

ZIP/Postal Code

81-348

Country

Poland

Facility Name

GSK Investigational Site

City

Koszalin

ZIP/Postal Code

75-581

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

GSK Investigational Site

City

Lubin

ZIP/Postal Code

59-301

Country

Poland

Facility Name

GSK Investigational Site

City

Radom

ZIP/Postal Code

26-617

Country

Poland

Facility Name

GSK Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

GSK Investigational Site

City

Walbrzych

ZIP/Postal Code

58-309

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-637

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

04-073

Country

Poland

Facility Name

GSK Investigational Site

City

Wloclawek

ZIP/Postal Code

87-800

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

GSK Investigational Site

City

Barnaul

ZIP/Postal Code

656055

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Krasnodar

ZIP/Postal Code

350086

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

109240

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Perm

ZIP/Postal Code

614107

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St'Petersburg

ZIP/Postal Code

194156

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St-Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634012

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Voronezh

ZIP/Postal Code

394066

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

GSK Investigational Site

City

Galdakao

ZIP/Postal Code

48960

Country

Spain

Facility Name

GSK Investigational Site

City

León

ZIP/Postal Code

24071

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28047

Country

Spain

Facility Name

GSK Investigational Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

GSK Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07014

Country

Spain

Facility Name

GSK Investigational Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

GSK Investigational Site

City

Vigo/Pontevedra

ZIP/Postal Code

36200

Country

Spain

Facility Name

GSK Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Southampton

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Tooting, London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

20805623

Citation

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.

Results Reference

background

PubMed Identifier

25873729

Citation

Ducrocq 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.

Results Reference

derived

PubMed Identifier

21146654

Citation

Steg 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.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108888

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108888

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108888

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108888

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108888

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108888

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108888

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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

Acute Coronary Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial