Skip to main content
OpenTrials
Completed

NCT Number: NCT00139815

Michelangelo - Oasis 5

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thromboembolism Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Embolism and Thrombosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fondaparinux

Drug

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

Enoxaparin

Drug

enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days

Primary outcomes

  1. death, myocardial infarction or refractory

    Time frame: up to and including Day 9

    first occurrence of any component of death, myocardial infarction or

  2. major bleeding

    Time frame: Up to Day 9

    incidence of adjudicated major bleeding

Secondary outcomes

  1. Death, myocardial infarction or refractory

    Time frame: up to Day 9, Day 14, Day 30,

    Incidence of the individual components of death, myocardial

  2. major bleeding

    Time frame: up to and including Day 14, Day

    incidence of adjudicated major bleeding

  3. 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

  4. Severe bleeding complications

    Time frame: up to and including Day 9, Day

    Severe bleeding complications according to modified thrombolysis in

  5. Death, myocardial infarction

    Time frame: up to Days 9, 14, 30, 90 and

    composite of death, myocardial infarction

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Duke University
  • Organon
  • Sanofi
  • University of Chicago

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Aug 31, 2005
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.