AzTrials
AzTrials

ThromboembolismPhase 3NCT00139815

Michelangelo - Oasis 5

A Phase 3 study testing Fondaparinux and enoxaparin in people with Thromboembolism, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Thromboembolism
What is being tested?
Fondaparinux and enoxaparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20,078 participants
Where
No sites listed yet
Study dates
Apr 2003to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read more

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
Read the 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]).

Conditions
Thromboembolism
Being tested
Fondaparinux, enoxaparin
Keywords
unstable angina, acute coronary syndrome, fondaparinux sodium, non ST segment elevation myocardial infarction, myocardial infarction
Medical subject headings
Thromboembolism, Angina, Unstable, Acute Coronary Syndrome, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FondaparinuxDrug

    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

  • enoxaparinDrug

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

Study groups in NCT00139815
Study groupRoleWhat they receive
EnoxaparinActive comparatorNot described
Receives: Drug: enoxaparin
FondaparinuxExperimentalNot described
Receives: Drug: Fondaparinux

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. death, myocardial infarction or refractory

    first occurrence of any component of death, myocardial infarction or

    Measured: up to and including Day 9

  2. major bleeding

    incidence of adjudicated major bleeding

    Measured: Up to Day 9

Secondary outcomes (5)

  1. Death, myocardial infarction or refractory

    Incidence of the individual components of death, myocardial

    Measured: up to Day 9, Day 14, Day 30,

  2. major bleeding

    incidence of adjudicated major bleeding

    Measured: up to and including Day 14, Day

  3. Any bleeding (major or minor)

    Any bleeding (major or minor) as reported by the investigator as

    Measured: up to and including Day 9, Day

  4. Severe bleeding complications

    Severe bleeding complications according to modified thrombolysis in

    Measured: up to and including Day 9, Day

  5. Death, myocardial infarction

    composite of death, myocardial infarction

    Measured: up to Days 9, 14, 30, 90 and

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2005 (estimated)
  2. Study startApr 2003
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20,078 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00139815
Sponsor's protocol ID
103420
Status last verified
Sep 2016
First submitted
29 Aug 2005
Last updated
15 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 16537663

  • 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.

    PubMed 20124123

  • 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.

    PubMed 19825809

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fondaparinux and enoxaparin in people with Thromboembolism, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

death, myocardial infarction or refractory (time frame: up to and including Day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00139815, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in