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Study ID

123456

Study Title FondaparinUx Trial with Unfractionated Heparin (UFH) during Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with Unstable Angina/Non ST segment elevation myocardial infarction (UA/NSTEMI) initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)
Patient Level Data Study Listed on ClinicalStudyDataRequest.com
Clinicaltrials.gov Identifier ABC00000000
Sponsor Company
Collaborators N/A
Study Recruitment Status Completed
Generic Name fondaparinux sodium
Trade Name Arixtra
Study Indication Acute Coronary Syndrome; acute coronary syndrome
Study Participant Screener PARTICIPANTS REGISTER HERE
Study Investigator Screener INVESTIGATORS REGISTER HERE
Study Data Request REQUEST STUDY DATA HERE
First Received Last Updated
November 06, 2008 July 09, 2015
Title FondaparinUx Trial with Unfractionated Heparin (UFH) during Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with Unstable Angina/Non ST segment elevation myocardial infarction (UA/NSTEMI) initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)
Phase phase 4
Acronym FUTURA/OASIS 8
Secondary IDs
FDA Regulated Intervention? Yes
Section 801 Clinical Trial Yes
Delayed Posting No
IND/IDE Protocol yes
IND/IDE Grantor CDER
IND/IDE Number 51,126
IND/IDE Serial Number
Has Expanded Access no
Study Type Interventional
Oversight Authority
  • Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
  • Russia: Russian Ministry of Health
  • Canada: Health Canada
  • Brazil: ANVISA
  • United Kingdom: Medicines and Healthcare products Regulatory Agency
  • South Korea: Food and Drug Administration
  • Argentina: Ministry of Health - A.N.M.A.T
  • India: Drugs Controlle Gerneral of India
  • Europe: European Medicines Agency
  • Japan: Ministry of Health, Labour and Welfare
  • United States: Food and Drug Administration
Sponsor Company
Collaborators
Brief Summary The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.
Detailed Description Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo angiography (ideally within 72 hours) will be assessed for eligibility and consented. Suitable subjects will be enrolled and commence treatment with open-label fondaparinux, 2.5 milligram (mg), subcutaneous (s.c.), once daily. Following angiography subjects indicated for PCI and meeting the additional requirements for randomization will be randomised to receive one of two dose regimens of UFH either standard dose or low dose immediately prior to the PCI procedure. Post-PCI, therapy with fondaparinux (2.5 mg, s.c.) may be resumed at the investigator’s discretion for up to a maximum of 8 days or hospital discharge, whichever is earlier. Subjects not indicated for PCI, will continue treatment with fondaparinux, 2.5mg, s.c, once daily for up to 8 days or hospital discharge, whichever is earlier. All subjects will be followed up for 30 days after randomization/angiography.
Record Verification Date June 23, 2011
Status Completed
Why Study Stopped
Study Start Date February 2009
Study Completion Date May 2010
Study Completion Date Type Actual
Primary Completion Date May 2010
Primary Completion Date Type Actual
Primary Purpose treatment
Allocation Randomized
Masking Double Blind
Masked Subject yes
Masked Caregiver yes
Masked Investigator yes
Masked Assessor yes
Study Design (Assignment) Parallel Assignment
Study Classification (Endpoint) Safety Study
Primary Outcomes
  • Composite of major bleeding, minor bleeding or major vascular access site complications
    Time Frame: Time of randomization up to 48 hours post PCI procedure
    Safety Issue: No
Secondary Outcomes
  • Major vascular access site complications
    Time Frame: Over the course of the study
    Safety Issue: No
  • Composite of major bleeding with death, MI or target vessel revascularization
    Time Frame: Major bleeding from randomisation until 48 hours post PCI; Death, MI or target vessel revascularisation at Day 30
    Safety Issue: No
  • Major PCI-related procedural complications
    Time Frame: Randomization until 48 hours following PCI
    Safety Issue: No
  • Definite and probable stent thrombosis
    Time Frame: Over the course of the study
    Safety Issue: No
  • Stroke
    Time Frame: Over the course of the study
    Safety Issue: No
  • Major bleeding, minor bleeding assessed separately
    Time Frame: Over the course of the study
    Safety Issue: No
  • Composite of death, MI, target vessel revascularization plus the components assessed separately
    Time Frame: Over the course of the study
    Safety Issue: No
Arms
  • Open label fondaparinux background and standard dose UFH
    Subjects indicated for PCI and randomized to receive standard dose UFH

  • Open label fondaparinux background and low dose UFH
    Subjects indicated for PCI and randomized to receive low dose UFH

  • Open label fondapaparinux
    Subjects not indicated for PCI and not randomized

Interventions
  • fondaparinux background and standard dose UFH Type: drug
    Description: Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned glycoprotein [GP] IIb/IIIa inhibitor use: 60 units/kilogram (U/kg); no planned use: 85 U/kg and adjusted based on activated clotting time (ACT) [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
    Arms: Open label fondaparinux background and standard dose UFH

  • Open label fondaparinux Type: drug
    Description: Open-label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for PCI and not randomized
    Arms: Open label fondapaparinux

  • Fondaparinux background and low dose heparin Type: drug
    Description: Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose UFH (50 U/kg), which was not adjusted for planned GPIIb/IIIa inhibitor use or ACT). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
    Arms: Open label fondaparinux background and low dose UFH

Conditions
  • acute coronary syndrome
Keywords
  • Unstable angina
  • Non ST elevation myocardial infarction
  • PCI
  • unfractionated heparin
  • fondaparinux
  • acute coronary syndrome
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender Both
Minimum Age 21 Years
Maximum Age
Enrollment 3235
Enrollment Type Actual
Healthy Volunteers none
Central Contact Call Center
Central Contact Phone 123-456-7890
Central Contact Email ClinicalSupport@Company.com
Overall Study Official Company Clinical Trials
Overall Study Official Affiliation Company
Overall Study Official Role Study Director
Responsible Party Name/Official Title John Doe; Clinical Disclosure Advisor
Responsible Party Organization Company Clinical Disclosure