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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Notify MeKey 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
Primary outcomes
-
Maximum intensity of platelet aggregation induced by ADP 5 µmol/L.
Secondary outcomes
-
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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