OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction
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.
1 other identifier
interventional
12,092
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2003
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2003
CompletedStudy Start
First participant enrolled
August 1, 2003
CompletedFirst Posted
Study publicly available on registry
October 17, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedSeptember 23, 2016
September 1, 2016
2.5 years
July 8, 2003
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Death or recurrent myocardial infarction
the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction
up to day 30
Severe hemorrhage
Severe hemorrhage (modified TIMI criteria)
up to Day 9
Secondary Outcomes (2)
Death or recurrent myocardial infarction
up to Day 9, 90 and 180
Death, recurrent myocardial infarction or refractory ischemia
up to Day 9, 30, 90 and 180
Study Arms (4)
Fondaparinux - UFH not indicated
EXPERIMENTALSubjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge
Control - UFH not indicated
PLACEBO COMPARATORSubjects with no indication for UFH therapy: Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Fondaparinux - UFH indicated
EXPERIMENTALSubjects indicated for UFH: 2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus + 24-48 hr infusion
Control - unfractionated heparin
ACTIVE COMPARATORSubjects indicated for 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
Interventions
2.5mg od, sc (1st dose IV) x 8 days or discharge
Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion
UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Eligibility Criteria
You may qualify if:
- Subjects who presented or were admitted to hospital with:
- Signs and symptoms of AMI
- Were able to randomize within 12 hours of symptom onset; and-
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- Sanoficollaborator
Related Publications (2)
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 myocardial infarction: the OASIS-6 randomized trial. JAMA. 2006 Apr 5;295(13):1519-30. doi: 10.1001/jama.295.13.joc60038. Epub 2006 Mar 14.
PMID: 16537725RESULTDiaz R, Goyal A, Mehta SR, Afzal R, Xavier D, Pais P, Chrolavicius S, Zhu J, Kazmi K, Liu L, Budaj A, Zubaid M, Avezum A, Ruda M, Yusuf S. Glucose-insulin-potassium therapy in patients with ST-segment elevation myocardial infarction. JAMA. 2007 Nov 28;298(20):2399-405. doi: 10.1001/jama.298.20.2399.
PMID: 18042917DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2003
First Posted
October 17, 2003
Study Start
August 1, 2003
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
September 23, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.