Status:
COMPLETED
ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Ischemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00360386
Start Date
March 1 2004
End Date
February 1 2005
Last Update
August 31 2010
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