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

August 30, 2010 updated by: Sanofi

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

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

110

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: SAGNARD Luc, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 3, 2006

First Posted (Estimate)

August 4, 2006

Study Record Updates

Last Update Posted (Estimate)

August 31, 2010

Last Update Submitted That Met QC Criteria

August 30, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C_9108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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