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ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"

Primary Purpose

Ischemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient hospitalised with ischemic symptoms (onset < 48 hours) and at least one of the following characteristics of NSTEMI: ECG ST or T changes positive troponin Patient treated on admission with 250-500 mg aspirin (oral or IV) and who will receive low dose aspirin (< or = 100 mg daily) from the next day on Patient treated with bid LMWH (indicated dosage for this indication) Exclusion Criteria: Catheterization scheduled within 24 hours after randomisation Patient presenting an absolute contra-indication to the use of clopidogrel and/or ASA: - history of drug allergy to thienopyridine derivatives or ASA Severe uncontrolled hypertension (BP > 180 / 100 despite therapy) Platelet count < 100 000 / mm3 Neutrophil count < 1800 / mm3 Patient with increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy History of severe systemic bleeding Patient with any contraindication to LMWH Patient treated with clopidogrel within the last 10 days Patient treated with oral anticoagulants or hirudin or planned to receive these products during the hospitalisation period Patient treated with ticlopidine, dipyridamol, NSAIDs (including Cox1 and Cox2 inhibitors), cilostazol, GPIIb IIIa antagonists or planned to receive any of these products within the next 24 hours following randomisation. Patient whose arm venous status is incompatible with an indwelling catheter Patient presenting an evolving cancer Patient with NYHA class IV heart failure Intubated and ventilated patient

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Maximum intensity of platelet aggregation induced by ADP 5 µmol/L.

    Secondary Outcome Measures

    Kinetic profile by aggregometry. Kinetic profile of platelet activation by flow cytometry - Inflammation parameters/markers of necrosis. Death, myocardial infarction, ischemic recurrences leading to revascularisation and/or rehospitalisation.Safety.

    Full Information

    First Posted
    August 3, 2006
    Last Updated
    August 30, 2010
    Sponsor
    Sanofi
    Collaborators
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00360386
    Brief Title
    ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"
    Official Title
    Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    February 2005 (Actual)
    Study Completion Date
    February 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi
    Collaborators
    Bristol-Myers Squibb

    4. Oversight

    5. Study Description

    Brief Summary
    To compare the Kinetics of inhibition of platelet aggregation (aggregometry) and platelet activation (flow cytometry) with different loading doses of clopidogrel To evaluate the effect on various parameters of inflammation and necrosis and the safety of these loading doses

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    110 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel
    Primary Outcome Measure Information:
    Title
    Maximum intensity of platelet aggregation induced by ADP 5 µmol/L.
    Secondary Outcome Measure Information:
    Title
    Kinetic profile by aggregometry. Kinetic profile of platelet activation by flow cytometry - Inflammation parameters/markers of necrosis. Death, myocardial infarction, ischemic recurrences leading to revascularisation and/or rehospitalisation.Safety.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient hospitalised with ischemic symptoms (onset < 48 hours) and at least one of the following characteristics of NSTEMI: ECG ST or T changes positive troponin Patient treated on admission with 250-500 mg aspirin (oral or IV) and who will receive low dose aspirin (< or = 100 mg daily) from the next day on Patient treated with bid LMWH (indicated dosage for this indication) Exclusion Criteria: Catheterization scheduled within 24 hours after randomisation Patient presenting an absolute contra-indication to the use of clopidogrel and/or ASA: - history of drug allergy to thienopyridine derivatives or ASA Severe uncontrolled hypertension (BP > 180 / 100 despite therapy) Platelet count < 100 000 / mm3 Neutrophil count < 1800 / mm3 Patient with increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy History of severe systemic bleeding Patient with any contraindication to LMWH Patient treated with clopidogrel within the last 10 days Patient treated with oral anticoagulants or hirudin or planned to receive these products during the hospitalisation period Patient treated with ticlopidine, dipyridamol, NSAIDs (including Cox1 and Cox2 inhibitors), cilostazol, GPIIb IIIa antagonists or planned to receive any of these products within the next 24 hours following randomisation. Patient whose arm venous status is incompatible with an indwelling catheter Patient presenting an evolving cancer Patient with NYHA class IV heart failure Intubated and ventilated patient
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SAGNARD Luc
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16949482
    Citation
    Montalescot G, Sideris G, Meuleman C, Bal-dit-Sollier C, Lellouche N, Steg PG, Slama M, Milleron O, Collet JP, Henry P, Beygui F, Drouet L; ALBION Trial Investigators. A randomized comparison of high clopidogrel loading doses in patients with non-ST-segment elevation acute coronary syndromes: the ALBION (Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis) trial. J Am Coll Cardiol. 2006 Sep 5;48(5):931-8. doi: 10.1016/j.jacc.2006.04.090. Epub 2006 Aug 17.
    Results Reference
    result

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    ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"

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