OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction

NCT ID: NCT00064428

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12092 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2006-02-28

Brief Summary

This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.

Detailed Description

This is a randomized, double blind, controlled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI randomized within 24 hours of the onset of symptoms. Patients with confirmed STEMI were assigned into one of the following strata, based on local preference:

Stratum 1: No indication for UFH; it is generally accepted that patients receiving streptokinase or those not receiving a thrombolytic agent were assigned to this stratum.

Stratum 2: Indication for UFH; it is generally accepted that patients receiving a fibrin-specific agent (such as alteplase, reteplase or tenecteplase) or those undergoing primary PCI were assigned to this stratum.

Patients who were ineligible for fibrinolysis (e.g. because of late presentation or absolute contra-indication for reperfusion therapy) may fall into either stratum 1 or stratum 2 at investigator's discretion. Following allocation to one of the strata, patients were randomized to fondaparinux or control treatment. Control treatment was dependent on whether the patient was assigned to stratum 1 or stratum 2:

Stratum 1: fondaparinux sc* versus fondaparinux-placebo sc for 8 days or until hospital discharge, whichever was earlier.

Stratum 2: fondaparinux sc* for 8 days or until hospital discharge, whichever was earlier and UFH-placebo for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) versus UFH for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) and fondaparinux-placebo for 8 days or until hospital discharge, whichever was earlier.

(*First dose intravenous bolus) Patients were followed up for 6 months

Conditions

Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fondaparinux - UFH not indicated

Subjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge

Group Type: EXPERIMENTAL

fondaparinux - UFH not indicated

Intervention Type: DRUG

2.5mg od, sc (1st dose IV) x 8 days or discharge

Control - UFH not indicated

Subjects with no indication for UFH therapy: Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Group Type: PLACEBO_COMPARATOR

Control - UFH not indicated

Intervention Type: OTHER

Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Fondaparinux - UFH indicated

Subjects indicated for UFH: 2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus + 24-48 hr infusion

Group Type: EXPERIMENTAL

Fondaparinux - UFH indicated

Intervention Type: DRUG

2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion

Control - unfractionated heparin

Subjects indicated for UFH: UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Group Type: ACTIVE_COMPARATOR

Control - UFH

Intervention Type: DRUG

UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Interventions

fondaparinux - UFH not indicated

2.5mg od, sc (1st dose IV) x 8 days or discharge

Intervention Type: DRUG

Control - UFH not indicated

Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Intervention Type: OTHER

Fondaparinux - UFH indicated

2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion

Intervention Type: DRUG

Control - UFH

UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects who presented or were admitted to hospital with:

1. Signs and symptoms of AMI

2. Were able to randomize within 12 hours of symptom onset; and-

3. Had definite ECG changes indicating STEMI: persistent ST-elevation (≥0.2mV in two contiguous precordial leads, or ≥0.1mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI.

• Written informed consent
• Able to be randomized within 24 hours of symptom onset

Exclusion Criteria

• Age <21 years.
• Was currently receiving an oral anticoagulant agent with an INR >1.8.
• Had any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding.
• Had hemorrhagic stroke within the last 12 months.
• Had an indication for anticoagulation other than ACS.
• Pregnant women or women of child-bearing potential who were not using an effective method of contraception.
• Had a co-morbid condition with a life-expectancy <6 months.
• Previous enrollment in one of the fondaparinux ACS trials.
• Participation in another pharmacotherapeutic study within the prior 30 days or was currently receiving an experimental pharmacological agent.
• Had a known allergy to heparin or fondaparinux.
• Had severe renal insufficiency (i.e. serum creatinine ≥3mg/dL or ≥265μmol/L).
• Had >5000IU UFH administered prior to randomization.
• Had LMWH administered prior to randomization.
• Subject had pre-randomization revascularization (PCI) for the index event.
• Subject had pre-randomization rescue PCI.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA; OASIS-6 Trial Group. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. JAMA. 2006 Apr 5;295(13):1519-30. doi: 10.1001/jama.295.13.joc60038. Epub 2006 Mar 14.

Reference Type: RESULT

PMID: 16537725 (View on PubMed)

Diaz R, Goyal A, Mehta SR, Afzal R, Xavier D, Pais P, Chrolavicius S, Zhu J, Kazmi K, Liu L, Budaj A, Zubaid M, Avezum A, Ruda M, Yusuf S. Glucose-insulin-potassium therapy in patients with ST-segment elevation myocardial infarction. JAMA. 2007 Nov 28;298(20):2399-405. doi: 10.1001/jama.298.20.2399.

Reference Type: DERIVED

PMID: 18042917 (View on PubMed)

Study Documents

Document Type: Dataset Specification

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

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Document Type: Clinical Study Report

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

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Document Type: Study Protocol

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

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Document Type: Statistical Analysis Plan

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

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Document Type: Annotated Case Report Form

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

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Document Type: Informed Consent Form

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Related Links

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Other Identifiers

103413

Identifier Type: -

Identifier Source: org_study_id

NCT01352156

Identifier Type: -

Identifier Source: nct_alias