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

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360386
• Other study ID #: C_9108
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2006
• Last updated: August 30, 2010
• Start date: March 2004
• Est. completion date: February 2005

Study information

• Verified date: August 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia

Intervention

Drug:
• Clopidogrel

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

References & 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-segme — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum intensity of platelet aggregation induced by ADP 5 µmol/L.
Secondary	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.