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

Phase 4

Completed

• Conditions: Stable Angina
• Interventions: Drug: atorvastatin and clopidogrel; Drug: Clopidogrel

• Registration Number: NCT01335048
• Lead Sponsor: Ospedale Misericordia e Dolce

Brief 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Primary Completion: 2011-12
• Status Verified: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Stable angina
• candidates to drug eluting stent implantation
• High on-treatment platelet reactivity according to a point-of-care platelet function test

Exclusion Criteria

• chronic therapy with statins
• inability to provide informed consent
• intolerance to statins
• acute or chronic liver failure or ALT > 2 times ULN
• known myopathy
• CKD stage IV or dialysis treatment
• pregnancy or breast-feeding
• malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin-Clopidogrel group	atorvastatin and clopidogrel	Patients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day
Clopidogrel group	Clopidogrel	Patients who receive clopidogrel 150 mg daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in on-treatment platelet reactivity at 7 and 30 days	pre-PCI, 7 days and 30 days	Pharmacodynamic analysis of the randomized groups includes a) assessment of the absolute level of on-treatment reactivity, b) change in on-treatment reactivity, c) rate of high on-treatment reactivity at 7 and 30 days. The platelet reactivity is measured with the VerifyNow P2Y12 test (Accumetrics, SanDiego, CA).

Trial Locations

Locations (1)

Cardiology Department, Ospedale Misericordia e Dolce; 🇮🇹 Prato, Italy