Michelangelo - Oasis 5

Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139815
• Other study ID #: 103420
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: September 13, 2016
• Start date: April 2003
• Est. completion date: December 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug ControlEstonia: State Agency of MedicinesMexico: Ministry of HealthPortugal: Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile:Ministerio de Salud de ChileGreece: National Organization of MedicinesHungary: National Institute of PharmacyMalaysia: Ministry of HealthSingapore: Health Sciences AuthorityUnited Arab Emirates: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesLatvia: State Agency of MedicinesUnited States: Food and Drug AdministrationFinland: Finnish Medicines AgencyTaiwan: Department of HealthLithuania: SMCA (State Medicine Control Agency)Austria: BMGF, Bundesministerium für Gesundheit und FrauenNorway: Norwegian Medicines AgencyBrazil: ANVISARussia: Russian Ministry of HealthSpain:Agencia Espanola de Medicamentos y Productos SanitariosUkraine: State Pharmacological Center of Ministry of Health of UkraineUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ministry of HealthHong Kong: Department of HealthBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentSwitzerland: SwissmedicDenmark: Danish Medicines AgencyFrance: Agence Française de Sécurité Sanitaire des Produits de SantéAustralia: Department of Health and Ageing Therapeutic Goods AdministrationSouth Africa: Department of HealthCroatia: Ministry of health and Social WelfareNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of Health & Social WelfareSweden: Medical Products AgencyCanada: Health CanadaChina: Food and Drug AdministrationSouth Korea: Food and Drug AdministrationIndia: Drugs Controller General of India (DCGI)Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

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]).

Other known NCT identifiers

• NCT01352169

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20078
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
GlaxoSmithKline	Duke University, Organon, Sanofi, University of Chicago

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death, myocardial infarction or refractory	first occurrence of any component of death, myocardial infarction or	up to and including Day 9	No
Primary	major bleeding	incidence of adjudicated major bleeding	Up to Day 9	Yes
Secondary	Death, myocardial infarction or refractory	Incidence of the individual components of death, myocardial	up to Day 9, Day 14, Day 30,	No
Secondary	major bleeding	incidence of adjudicated major bleeding	up to and including Day 14, Day	Yes
Secondary	Any bleeding (major or minor)	Any bleeding (major or minor) as reported by the investigator as	up to and including Day 9, Day	Yes
Secondary	Severe bleeding complications	Severe bleeding complications according to modified thrombolysis in	up to and including Day 9, Day	Yes
Secondary	Death, myocardial infarction	composite of death, myocardial infarction	up to Days 9, 14, 30, 90 and	No

External Links

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