Michelangelo - Oasis 5

This study has been completed.
Sponsor:
Collaborators:
University of Chicago
Organon
Sanofi
Duke University
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00139815
First received: August 29, 2005
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

Study Objectives

PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.

SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.

  • To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
  • To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
  • To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180

Study Drug: Patients will be randomized to receive either:

  • Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
  • Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection

Duration of Therapy:

  • Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
  • Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.
  • Patients should receive an ASA and all other standard medical therapies.

Substudy:

  • A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (>48 hrs) coronary angiography and intervention.

Primary Outcome: The first occurence of any component of the following composite up to Day 9:

  • Death
  • Myocardial Infarction
  • Refractory Ischemia

Condition Intervention Phase
Myocardial Infarction
Drug: Fondaparinux
Drug: enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • death, myocardial infarction or refractory [ Time Frame: up to and including Day 9 ] [ Designated as safety issue: No ]
    first occurrence of any component of death, myocardial infarction or

  • major bleeding [ Time Frame: Up to Day 9 ] [ Designated as safety issue: Yes ]
    incidence of adjudicated major bleeding


Secondary Outcome Measures:
  • Death, myocardial infarction or refractory [ Time Frame: up to Day 9, Day 14, Day 30, ] [ Designated as safety issue: No ]
    Incidence of the individual components of death, myocardial

  • major bleeding [ Time Frame: up to and including Day 14, Day ] [ Designated as safety issue: Yes ]
    incidence of adjudicated major bleeding

  • Any bleeding (major or minor) [ Time Frame: up to and including Day 9, Day ] [ Designated as safety issue: Yes ]
    Any bleeding (major or minor) as reported by the investigator as

  • Severe bleeding complications [ Time Frame: up to and including Day 9, Day ] [ Designated as safety issue: Yes ]
    Severe bleeding complications according to modified thrombolysis in

  • Death, myocardial infarction [ Time Frame: up to Days 9, 14, 30, 90 and ] [ Designated as safety issue: No ]
    composite of death, myocardial infarction


Enrollment: 20078
Study Start Date: March 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enoxaparin Drug: enoxaparin
enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days
Experimental: Fondaparinux Drug: Fondaparinux
fondaparinux 2.5 mg, s.c. injection once daily x 8 days or Hospital Discharge if earlier and placebo-enoxaparin 1mg/kg s.c. injection twice daily x 2-8 days or until clinically stable

Detailed Description:

This is a double-blind, double-dummy, randomized, parallel-group, controlled trial to compare the safety and efficacy of fondaparinux and enoxaparin in subjects with UA/NSTEMI (unstable angina/non ST segment myocardial infarction). Study drug (s.c.) was started immediately following randomization; subjects received fondaparinux 2.5mg once daily s.c for 8 days or until hospital discharge, if earlier, or enoxaparin 1mg/kg twice daily s.c for 2 to 8 days or until clinically stable. In subjects with creatinine clearance between 20mL/min and 30mL/min, enoxaparin was administered as 1mg/kg once daily. In addition to study drug, subjects were to receive standard medical care, including interventions (PCI [percutaneous coronary intervention] or coronary artery bypass graft surgery [CABG]).

  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 symptoms suspected to represent an acute coronary syndrome.
  • Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
  • At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
  • Written informed consent

Exclusion Criteria:

  • Age < 21 years
  • Any contraindication to low molecular weight heparin
  • Hemorrhagic stroke within the last 12 months
  • Indication for anticoagulation other than ACS.
  • Pregnancy or women of childbearing potential who are not using an effective method of contraception
  • Co-morbid condition with life expectancy less than 6 months
  • Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent
  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: NCT00139815

Sponsors and Collaborators
GlaxoSmithKline
University of Chicago
Organon
Sanofi
Duke University
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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00139815     History of Changes
Obsolete Identifiers: NCT01352169
Other Study ID Numbers: 103420, EFC3197
Study First Received: August 29, 2005
Last Updated: October 13, 2011
Health Authority: Slovakia: State Institute for Drug Control
Estonia: State Agency of Medicines
Mexico: Ministry of Health
Portugal: Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile:Ministerio de Salud de Chile
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Malaysia: Ministry of Health
Singapore: Health Sciences Authority
United Arab Emirates: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Taiwan: Department of Health
Lithuania: SMCA (State Medicine Control Agency)
Austria: BMGF, Bundesministerium für Gesundheit und Frauen
Norway: Norwegian Medicines Agency
Brazil: ANVISA
Russia: Russian Ministry of Health
Spain:Agencia Espanola de Medicamentos y Productos Sanitarios
Ukraine: State Pharmacological Center of Ministry of Health of Ukraine
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Hong Kong: Department of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
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)
Poland: Ministry of Health & Social Welfare
Sweden: Medical Products Agency
Canada: Health Canada
China: Food and Drug Administration
South Korea: Food and Drug Administration
India: Drugs Controller General of India (DCGI)
Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
unstable angina
acute coronary syndrome
fondaparinux sodium
non ST segment elevation myocardial infarction
myocardial infarction

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Fondaparinux
PENTA
Enoxaparin
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 July 28, 2014