Michelangelo - Oasis 5

NCT00139815 | Completed Phase 3 DMC

• 1 other identifier: 103420
• Study Type: interventional
• Target: 20,078
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Thromboembolism

Keywords

unstable angina; acute coronary syndrome; fondaparinux sodium; non ST segment elevation myocardial infarction; myocardial infarction

Outcome Measures

Primary Outcomes (2)

• death, myocardial infarction or refractory

  first occurrence of any component of death, myocardial infarction or

  up to and including Day 9

• major bleeding

  incidence of adjudicated major bleeding

  Up to Day 9

Secondary Outcomes (5)

• Death, myocardial infarction or refractory

  up to Day 9, Day 14, Day 30,

• major bleeding

  up to and including Day 14, Day

• Any bleeding (major or minor)

  up to and including Day 9, Day

• Severe bleeding complications

  up to and including Day 9, Day

• Death, myocardial infarction

  up to Days 9, 14, 30, 90 and

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

Drug: enoxaparin

Fondaparinux

EXPERIMENTAL

Drug: Fondaparinux

Interventions

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

Fondaparinux

enoxaparin DRUG

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

Enoxaparin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• University of Chicago: collaborator
• Organon: collaborator
• Sanofi: collaborator
• Duke University: collaborator

Related Publications (3)

• Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators; Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006 Apr 6;354(14):1464-76. doi: 10.1056/NEJMoa055443. Epub 2006 Mar 14.

  PMID: 16537663 RESULT

• Chow CK, Jolly S, Rao-Melacini P, Fox KA, Anand SS, Yusuf S. Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes. Circulation. 2010 Feb 16;121(6):750-8. doi: 10.1161/CIRCULATIONAHA.109.891523. Epub 2010 Feb 1.

  PMID: 20124123 DERIVED

• Bassand JP, Afzal R, Eikelboom J, Wallentin L, Peters R, Budaj A, Fox KA, Joyner CD, Chrolavicius S, Granger CB, Mehta S, Yusuf S; OASIS 5 and OASIS 6 Investigators. Relationship between baseline haemoglobin and major bleeding complications in acute coronary syndromes. Eur Heart J. 2010 Jan;31(1):50-8. doi: 10.1093/eurheartj/ehp401. Epub 2009 Oct 12.

  PMID: 19825809 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Thromboembolism; Angina, Unstable; Acute Coronary Syndrome; Myocardial Infarction

Interventions

Fondaparinux; Enoxaparin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: April 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share