Michelangelo - Oasis 5
This study has been completed.
Sponsor:
GlaxoSmithKline
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
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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 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 May 22, 2013