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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00064428
Recruitment Status : Completed
First Posted : October 17, 2003
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 8, 2003
First Posted Date  ICMJE October 17, 2003
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE August 2003
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • 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
  • Severe hemorrhage [ Time Frame: up to Day 9 ]
    Severe hemorrhage (modified TIMI criteria)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction
Official Title  ICMJE 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Thromboembolism
Intervention  ICMJE
  • Drug: fondaparinux - UFH not indicated
    2.5mg 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Fondaparinux - UFH not indicated
    Subjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge
    Intervention: Drug: fondaparinux - UFH not indicated
  • 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
    Intervention: Other: Control - UFH not indicated
  • 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
    Intervention: Drug: Fondaparinux - UFH indicated
  • 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
    Intervention: Drug: Control - UFH
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2011)
12092
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
10000
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Ukraine,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00064428
Other Study ID Numbers  ICMJE 103413
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP