OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction

Thromboembolism Clinical Trial

Official title:

An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064428
• Other study ID #: 103413
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2003
• Last updated: September 22, 2016
• Start date: August 2003
• Est. completion date: February 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Agencia Espanola de Medicamentos y Productos SanitariosSlovakia: State Institute for Drug ControlMexico: Ministry of HealthPortugal: The National Institue of Pharmacy and Medicines (Infarmed)Belgium: Federal Agency for Medicinal Products and Health ProductsBrazil: National Health Surveillance AgencySlovenia: Ministry of Health Agency for Medicinal ProductsChile:Ministerio de Salud de ChileGreece: National Organization of MedicinesHungary: National Institute of PharmacyLatvia: State Agency of MedicinesUnited States: Food and Drug AdministrationTaiwan: Department of HealthLithuania: SMCA (State Medicine Control Agency)Austria: BMGF, Bundesministerium für Gesundheit und FrauenRussia: Russian Ministry of HealthUkraine: State Pharmacological Center of Ministry of Health of UkraineItaly: Ministry of HealthRomania: Minister of HealthGermany: Federal Institute for Drugs and Medical DevicesArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaHong Kong: Department of HealthEstonia: The State Agency of MedicineCanada: Health CanadaSwitzerland: 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)Malaysia: National Pharmaceutical Control BureauIsrael: Ministry of HealthPoland: Ministry of Health & Social WelfareSweden: Medical Products AgencyChina: Food and Drug AdministrationBulgaria: Bulgarian Drug Agency (BDA)South Korea: Food and Drug AdministrationIndia: Drugs Controller General of India (DCGI)Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.

Description:

This is a randomized, double blind, controlled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI randomized within 24 hours of the onset of symptoms. Patients with confirmed STEMI were assigned into one of the following strata, based on local preference:

Stratum 1: No indication for UFH; it is generally accepted that patients receiving streptokinase or those not receiving a thrombolytic agent were assigned to this stratum.

Stratum 2: Indication for UFH; it is generally accepted that patients receiving a fibrin-specific agent (such as alteplase, reteplase or tenecteplase) or those undergoing primary PCI were assigned to this stratum.

Patients who were ineligible for fibrinolysis (e.g. because of late presentation or absolute contra-indication for reperfusion therapy) may fall into either stratum 1 or stratum 2 at investigator's discretion. Following allocation to one of the strata, patients were randomized to fondaparinux or control treatment. Control treatment was dependent on whether the patient was assigned to stratum 1 or stratum 2:

Stratum 1: fondaparinux sc* versus fondaparinux-placebo sc for 8 days or until hospital discharge, whichever was earlier.

Stratum 2: fondaparinux sc* for 8 days or until hospital discharge, whichever was earlier and UFH-placebo for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) versus UFH for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) and fondaparinux-placebo for 8 days or until hospital discharge, whichever was earlier.

(*First dose intravenous bolus) Patients were followed up for 6 months

Other known NCT identifiers

• NCT01352156

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12092
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Subjects who presented or were admitted to hospital with:

1. Signs and symptoms of AMI

2. Were able to randomize within 12 hours of symptom onset; and-

3. Had definite ECG changes indicating STEMI: persistent ST-elevation (=0.2mV in two contiguous precordial leads, or =0.1mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI.

• Written informed consent

• Able to be randomized within 24 hours of symptom onset

Exclusion Criteria:

• Age <21 years.

• Was currently receiving an oral anticoagulant agent with an INR >1.8.

• Had any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding.

• Had hemorrhagic stroke within the last 12 months.

• Had an indication for anticoagulation other than ACS.

• Pregnant women or women of child-bearing potential who were not using an effective method of contraception.

• Had a co-morbid condition with a life-expectancy <6 months.

• Previous enrollment in one of the fondaparinux ACS trials.

• Participation in another pharmacotherapeutic study within the prior 30 days or was currently receiving an experimental pharmacological agent.

• Had a known allergy to heparin or fondaparinux.

• Had severe renal insufficiency (i.e. serum creatinine =3mg/dL or =265µmol/L).

• Had >5000IU UFH administered prior to randomization.

• Had LMWH administered prior to randomization.

• Subject had pre-randomization revascularization (PCI) for the index event.

• Subject had pre-randomization rescue PCI.

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Thromboembolism

Intervention

Drug:
• fondaparinux - UFH not indicated
2.5mg od, sc (1st dose IV) x 8 days or discharge

Other:
• Control - UFH not indicated
Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Drug:
• Fondaparinux - UFH indicated
2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion
• Control - UFH
UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Sanofi

References & Publications (1)

Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA; OASIS-6 Trial Group. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or recurrent myocardial infarction	the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction	up to day 30	No
Primary	Severe hemorrhage	Severe hemorrhage (modified TIMI criteria)	up to Day 9	Yes
Secondary	Death or recurrent myocardial infarction	The first occurrence of any component of the composite of death (all-cause mortality) or recurrent myocardial infarction	up to Day 9, 90 and 180	No
Secondary	Death, recurrent myocardial infarction or refractory ischemia	The first occurrence of any component of the composite of death (all-cause mortality), recurrent myocardial infarction or refractory ischemia	up to Day 9, 30, 90 and 180	No

External Links

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