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

NCT00360386 | Completed Phase 2

• 1 other identifier: C_9108
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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 parameters of inflammation and necrosis and the safety of these loading doses

Conditions

Ischemia

Outcome Measures

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.

Interventions

Clopidogrel DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

Related Publications (1)

• Montalescot G, Sideris G, Meuleman C, Bal-dit-Sollier C, Lellouche N, Steg PG, Slama M, Milleron O, Collet JP, Henry P, Beygui F, Drouet L; ALBION Trial Investigators. A randomized comparison of high clopidogrel loading doses in patients with non-ST-segment elevation acute coronary syndromes: the ALBION (Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis) trial. J Am Coll Cardiol. 2006 Sep 5;48(5):931-8. doi: 10.1016/j.jacc.2006.04.090. Epub 2006 Aug 17.

  PMID: 16949482 RESULT

MeSH Terms

Conditions

Ischemia

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• SAGNARD Luc

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 4, 2006
• Study Start: March 1, 2004
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: August 31, 2010

Record last verified: 2010-08