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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00360386
First received: August 3, 2006
Last updated: August 30, 2010
Last verified: August 2010
  Purpose
  • 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 Intervention Phase
Ischemia
Drug: Clopidogrel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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.

Estimated Enrollment: 110
Study Start Date: March 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360386

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

Publications:
ClinicalTrials.gov Identifier: NCT00360386     History of Changes
Other Study ID Numbers: C_9108
Study First Received: August 3, 2006
Last Updated: August 30, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Clopidogrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014