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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360386
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : August 31, 2010
Bristol-Myers Squibb
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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

Condition or disease Intervention/treatment Phase
Ischemia Drug: Clopidogrel Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis.
Study Start Date : March 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Maximum intensity of platelet aggregation induced by ADP 5 µmol/L.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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
  2. 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
  3. Patient treated with bid LMWH (indicated dosage for this indication)

Exclusion Criteria:

  1. Catheterization scheduled within 24 hours after randomisation
  2. Patient presenting an absolute contra-indication to the use of clopidogrel and/or ASA:

    - history of drug allergy to thienopyridine derivatives or ASA

  3. Severe uncontrolled hypertension (BP > 180 / 100 despite therapy)
  4. Platelet count < 100 000 / mm3
  5. Neutrophil count < 1800 / mm3
  6. Patient with increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
  7. History of severe systemic bleeding
  8. Patient with any contraindication to LMWH
  9. Patient treated with clopidogrel within the last 10 days
  10. Patient treated with oral anticoagulants or hirudin or planned to receive these products during the hospitalisation period
  11. 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.
  12. Patient whose arm venous status is incompatible with an indwelling catheter
  13. Patient presenting an evolving cancer
  14. Patient with NYHA class IV heart failure
  15. Intubated and ventilated patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00360386

Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: SAGNARD Luc Sanofi

Publications of Results:
Layout table for additonal information Identifier: NCT00360386     History of Changes
Other Study ID Numbers: C_9108
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
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Pathologic Processes
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs