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OpenTrials
Completed

NCT Number: NCT00360386

ALBION "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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Aug 4, 2006
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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