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

NCT ID: NCT00360386

Last Updated: 2010-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Clopidogrel

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

SAGNARD Luc

Role: STUDY_DIRECTOR

Sanofi

References

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.

Reference Type: RESULT

PMID: 16949482 (View on PubMed)

Other Identifiers

C_9108

Identifier Type: -

Identifier Source: org_study_id