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Michelangelo - Oasis 5

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction

Intervention: Fondaparinux (Drug); enoxaparin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

death, myocardial infarction or refractory

major bleeding

Secondary outcome:

Death, myocardial infarction or refractory

major bleeding

Any bleeding (major or minor)

Severe bleeding complications

Death, myocardial infarction

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

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: March 2003
Last updated: October 13, 2011

Page last updated: August 20, 2015

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