NCT01335048

Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ospedale Misericordia e Dolce · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable patients with high on-treatment reactivity according to a point-of-care platelet function assay.

Detailed description

This is a prospective, randomized, open-label, control-active trial performed in elective patients candidates to coronary drug eluting stent implantation who presented high-on-treatment platelet reactivity, immediately before coronary intervention (PCI). All patients are treated with aspirin (100 mg/day) and standard-dose clopidogrel (600 mg as loading dose and 75 mg daily as maintenance dose)for at least 7 days before PCI. Platelet function is assessed by the VerifyNow P2Y12 assay (Accumetrics, San Diego, CA). Patients are eligible to be enrolled if they have high-on-treatment reactivity defined as P2Y12 reaction units (PRU) \>= 230, immediately before PCI. After PCI, patients are randomized to receive high-dose clopidogrel (150 mg daily) or high-dose atorvastatin (80mg/day) + high-dose clopidogrel (150 mg daily). Study visits and platelet function testing with the VerifyNow P2Y12 test are conducted at 7 and 30 days after randomization.

Conditions

• Stable Angina

Interventions

Type	Name	Description
DRUG	atorvastatin and clopidogrel	Atorvastatin 80 mg daily + clopidogrel 150 mg daily
DRUG	Clopidogrel	Clopidogrel 150 mg daily

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2011-04-13
• Last updated: 2012-01-26

Locations

1 site across 1 country: Italy