ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00360386
First received: August 3, 2006
Last updated: August 30, 2010
Last verified: August 2010
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Purpose
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemia |
Drug: Clopidogrel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Maximum intensity of platelet aggregation induced by ADP 5 µmol/L.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 110 |
| Study Start Date: | March 2004 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00360386 History of Changes |
| Other Study ID Numbers: | C_9108 |
| Study First Received: | August 3, 2006 |
| Last Updated: | August 30, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Inflammation Ischemia Necrosis Pathologic Processes Clopidogrel Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013