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Michelangelo - Oasis 5

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139815
First Posted: August 31, 2005
Last Update Posted: September 15, 2016
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.
Collaborators:
University of Chicago
Organon
Sanofi
Duke University
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Thromboembolism Drug: Fondaparinux Drug: enoxaparin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    first occurrence of any component of death, myocardial infarction or

  • major bleeding [ Time Frame: Up to Day 9 ]
    incidence of adjudicated major bleeding


Secondary Outcome Measures:
  • Death, myocardial infarction or refractory [ Time Frame: up to Day 9, Day 14, Day 30, ]
    Incidence of the individual components of death, myocardial

  • major bleeding [ Time Frame: up to and including Day 14, Day ]
    incidence of adjudicated major bleeding

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

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

  • Death, myocardial infarction [ Time Frame: up to Days 9, 14, 30, 90 and ]
    composite of death, myocardial infarction


Enrollment: 20078
Study Start Date: April 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139815


Sponsors and Collaborators
GlaxoSmithKline
University of Chicago
Organon
Sanofi
Duke University
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 103420
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: 103420
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: 103420
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: 103420
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 103420
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 103420
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: 103420
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: NCT00139815     History of Changes
Obsolete Identifiers: NCT01352169
Other Study ID Numbers: 103420
First Submitted: August 29, 2005
First Posted: August 31, 2005
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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:
unstable angina
acute coronary syndrome
fondaparinux sodium
non ST segment elevation myocardial infarction
myocardial infarction

Additional relevant MeSH terms:
Acute Coronary Syndrome
Thromboembolism
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Fondaparinux
PENTA
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action