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MICHELANGELO OASIS-6 : Fondaparinux in ST Elevation Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00064428
First received: July 8, 2003
Last updated: August 22, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this research study is to determine the efficacy and safety of fondaparinux (Arixtra) in preventing death and repeat heart attacks and their complications.


Condition Intervention Phase
Myocardial Infarction
ST-elevation Myocardial Infarction
Acute Coronary Syndrome
Acute Myocardial Infarction
 Drug: Fondaparinux - UFH indicated
Other: Control - UFH not indicated
Drug: fondaparinux - UFH not indicated
Drug: Control - UFH
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Efficacy Trial Evaluating Fondaparinux Use in a Broad Range of Patients With ST Segment Elevation Acute MI

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Death or recurrent myocardial infarction [ Time Frame: up to day 30 ] [ Designated as safety issue: No ]
    the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction

  • Severe hemorrhage [ Time Frame: up to Day 9 ] [ Designated as safety issue: Yes ]
    Severe hemorrhage (modified TIMI criteria)


Secondary Outcome Measures:
  • Death or recurrent myocardial infarction [ Time Frame: up to Day 9, 90 and 180 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The first occurrence of any component of the composite of death (all-cause mortality), recurrent myocardial infarction or refractory ischemia


Enrollment: 12092
Study Start Date: August 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

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

Inclusion Criteria:

  • Patients presenting or admitted to hospital with: a) signs and symptoms of acute myocardial infarction (AMI) b) able to randomize within 24 hours from symptom onset, and c) definite ECG changes indicating STEMI: persistent ST-elevation (greater than or equal to 0.2 mV in two contiguous precordial leads, or greater than or equal to 0.1 mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI
  • written informed consent

Exclusion criteria:

  • age < 21 years
  • currently receiving an oral anticoagulant agent with an INR > 1.8
  • any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding
  • hemorrhagic stroke within the last 12 months
  • indication for anticoagulation other than acute coronary syndrome (ACS)
  • pregnant women or women of child-bearing potential who are not using an effective method of contraception
  • co-morbid condition with a life expectancy < 6 months
  • prior enrollment in one of the fondaparinux ACS trials
  • participation in another pharmacotherapeutic study within the prior 30 days or currently receiving an experimental pharmacological agent
  • known allergy to heparin or fondaparinux
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064428

  Show 382 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Sanofi
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00064428     History of Changes
Obsolete Identifiers: NCT01352156
Other Study ID Numbers: 103413, EFC5112
Study First Received: July 8, 2003
Last Updated: August 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Acute Myocardial Infarction
ST-segment elevation myocardial infarction
fondaparinux
acute coronary syndrome

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
 Pain
Signs and Symptoms
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013