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OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute 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: September 22, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Thromboembolism
Drug: fondaparinux - UFH not indicated
Other: Control - UFH not indicated
Drug: Fondaparinux - UFH 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: Treatment
Official Title: 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.

Resource links provided by NLM:


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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064428

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

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 103413
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 103413
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 103413
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 103413
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 103413
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 103413
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 103413
For additional information about this study please refer to the GSK Clinical Study Register

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 
Study First Received: July 8, 2003
Last Updated: September 22, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Slovakia: State Institute for Drug Control
Mexico: Ministry of Health
Portugal: The National Institue of Pharmacy and Medicines (Infarmed)
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Slovenia: Ministry of Health Agency for Medicinal Products
Chile:Ministerio de Salud de Chile
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
United States: Food and Drug Administration
Taiwan: Department of Health
Lithuania: SMCA (State Medicine Control Agency)
Austria: BMGF, Bundesministerium für Gesundheit und Frauen
Russia: Russian Ministry of Health
Ukraine: State Pharmacological Center of Ministry of Health of Ukraine
Italy: Ministry of Health
Romania: Minister of Health
Germany: Federal Institute for Drugs and Medical Devices
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Hong Kong: Department of Health
Estonia: The State Agency of Medicine
Canada: Health Canada
Switzerland: Swissmedic
Denmark: Danish Medicines Agency
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Australia: Department of Health and Ageing Therapeutic Goods Administration
South Africa: Department of Health
Croatia: Ministry of health and Social Welfare
Netherlands: Medicines Evaluation Board (MEB)
Malaysia: National Pharmaceutical Control Bureau
Israel: Ministry of Health
Poland: Ministry of Health & Social Welfare
Sweden: Medical Products Agency
China: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency (BDA)
South Korea: Food and Drug Administration
India: Drugs Controller General of India (DCGI)
Czech Republic: State Institute for Drug Control
Individual Participant Data  
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.

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thromboembolism
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Fondaparinux
PENTA
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016