ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemia
Intervention: Clopidogrel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
SAGNARD Luc, Study Director, Affiliation: Sanofi-Aventis
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
Clinical Details
Official title: Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis.
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Maximum intensity of platelet aggregation induced by ADP 5 µmol/L.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Clinical Study Results
Starting date: March 2004
Last updated: January 18, 2008
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