FondaparinUx Trial With UFH During Revascularization in Acute Coronary Syndromes - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00790907

Purpose

The purpose of this study is to compare the safety of two different dose regimens of unfractioned heparin (UFH) during a PCI procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initally treated with fondaparinux.

Condition	Intervention	Phase
Non ST Segment Elevation Myocardial Infarction Unstable Angina Acute Coronary Syndrome	Drug: Unfractioned heparin	Phase IV

MedlinePlus related topics: Angina Blood Thinners Heart Attack

Drug Information available for: Fondaparinux sodium ORG 31540 Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	FondaparinUx Trial With UFH During Revascularization in Acute Coronary Syndromes (FUTURA) A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With UA/NSTEMI Initially Treated With Subcutaneous Fondaparinux and Referred for Early

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Composite of major bleeding, minor bleeding or major vascular access site complications [ Time Frame: Time of randomisation up to 48 hours post PCI procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite of major bleeding with death, MI or target vessel revascularisation [ Time Frame: Major bleeding from randomisation until 48 hours post PCI; Death, MI or target vessel revascularisation at Day 30 ] [ Designated as safety issue: No ]
Major bleeding, minor bleeding assessed separately [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]
Major vascular access site complications [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]
Composite of death, MI, target vessel revascularisation plus the components assessed separately [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]
Stroke [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]
Definite and probable stent thrombosis [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]
Major PCI-related procedural complications [ Time Frame: Randomisation until 48 hours following PCI ] [ Designated as safety issue: No ]

Estimated Enrollment:	4000
Study Start Date:	February 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Standard dose UFH: Experimental No planned GPIIb/IIIa use: 85 U/kg bolus with additional bolus (2,000 U - 4,000U) if needed to achieve a target ACT of 300 - 350 seconds (using the HEMOCHRON device) or ACT of 250 - 300 seconds (using the HEMOTECH device). Planned GPIIb/IIIa use: 60 U/kg bolus with additional bolus of (2,000 U - 4,000U) if needed to achieve target ACT of ≥200 seconds (using the HEMOCHRON or HEMOTECH device)	Drug: Unfractioned heparin Fondaparinux treated patients, eligible for PCI, will be randomised to receive one of two doses of unfractionated heparin (UFH) at least 1 minute prior to insertion of the guidewire
Low Dose UFH: Experimental - All subjects irrespective of planned GPIIb/IIIa use: 50 U/kg bolus	Drug: Unfractioned heparin Fondaparinux treated patients, eligible for PCI, will be randomised to receive one of two doses of unfractionated heparin (UFH) at least 1 minute prior to insertion of the guidewire

Arms

Assigned Interventions

Standard dose UFH: Experimental

No planned GPIIb/IIIa use: 85 U/kg bolus with additional bolus (2,000 U - 4,000U) if needed to achieve a target ACT of 300 - 350 seconds (using the HEMOCHRON device) or ACT of 250 - 300 seconds (using the HEMOTECH device).
Planned GPIIb/IIIa use: 60 U/kg bolus with additional bolus of (2,000 U - 4,000U) if needed to achieve target ACT of ≥200 seconds (using the HEMOCHRON or HEMOTECH device)

Drug: Unfractioned heparin

Fondaparinux treated patients, eligible for PCI, will be randomised to receive one of two doses of unfractionated heparin (UFH) at least 1 minute prior to insertion of the guidewire

Low Dose UFH: Experimental

- All subjects irrespective of planned GPIIb/IIIa use: 50 U/kg bolus

Drug: Unfractioned heparin

Fondaparinux treated patients, eligible for PCI, will be randomised to receive one of two doses of unfractionated heparin (UFH) at least 1 minute prior to insertion of the guidewire

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 mg, s.c., once daily. Following angiography subjects indicated for PCI and meeting the additional requirements for randomisation 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 randomisation/angiography.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 enrolment 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;
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
haemodynamic instability
Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin or UFH for treatment of the qualifying events unless the last administered (i.v. or s.c.) dose was:
≥ 8 hours for LMWH
≥60 minutes for bivalirudin
≥90 minutes for UFH
Hemorrhagic stroke within the last 12 months.
Indication for anti-coagulation other than 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790907

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 146 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	108888
Study First Received:	November 13, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00790907
Health Authority:	Argentina: Ministry of Health - A.N.M.A.T; Brazil: ANVISA; Canada: Health Canada; Europe: European Medicines Agency; India: Drugs Controlle Gerneral of India; Japan: Ministry of Health, Labor and Welfare; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Russia: Russian Ministry of Health; South Korea: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

acute coronary syndrome
Unstable angina
Non ST elevation myocardial infarction

fondaparinux
unfractionated heparin
PCI

Study placed in the following topic categories:

Heart Diseases
Heparin, Low-Molecular-Weight
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Fondaparinux
Pain
Ischemia
Org 31540

Calcium heparin
Chest Pain
Signs and Symptoms
Necrosis
Acute Coronary Syndrome
Infarction
Heparin
Myocardial Infarction
Angina, Unstable

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Disease
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Syndrome
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009