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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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

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Stable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorvastatin-Clopidogrel group

Patients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day

Group Type EXPERIMENTAL

atorvastatin and clopidogrel

Intervention Type DRUG

Atorvastatin 80 mg daily + clopidogrel 150 mg daily

Clopidogrel group

Patients who receive clopidogrel 150 mg daily

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel 150 mg daily

Interventions

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