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

September 22, 2016 updated by: GlaxoSmithKline

An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

12092

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fondaparinux - UFH not indicated
Subjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge
Drug: fondaparinux - UFH not indicated
2.5mg od, sc (1st dose IV) x 8 days or discharge
Placebo Comparator: Control - UFH not indicated
Subjects with no indication for UFH therapy: Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Other: Control - UFH not indicated
Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Experimental: 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
Drug: Fondaparinux - UFH indicated
2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or recurrent myocardial infarction
Time Frame: up to day 30
the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction
up to day 30
Severe hemorrhage
Time Frame: up to Day 9
Severe hemorrhage (modified TIMI criteria)
up to Day 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or recurrent myocardial infarction
Time Frame: up to Day 9, 90 and 180
The first occurrence of any component of the composite of death (all-cause mortality) or recurrent myocardial infarction
up to Day 9, 90 and 180
Death, recurrent myocardial infarction or refractory ischemia
Time Frame: up to Day 9, 30, 90 and 180
The first occurrence of any component of the composite of death (all-cause mortality), recurrent myocardial infarction or refractory ischemia
up to Day 9, 30, 90 and 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

July 8, 2003

First Submitted That Met QC Criteria

October 16, 2003

First Posted (Estimate)

October 17, 2003

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Dataset Specification
    Information identifier: 103413
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 103413
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 103413
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 103413
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annotated Case Report Form
    Information identifier: 103413
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 103413
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: 103413
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thromboembolism

Clinical Trials on fondaparinux - UFH not indicated

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe