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

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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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiology Department, Ospedale Misericordia e Dolce

Prato, 59100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin and clopidogrel

Drug

Atorvastatin 80 mg daily + clopidogrel 150 mg daily

clopidogrel

Drug

Clopidogrel 150 mg daily

Primary outcomes

Change from baseline in on-treatment platelet reactivity at 7 and 30 days

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ospedale Misericordia e Dolce

Other

Registry information

Acronym: ACHIDO

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Apr 13, 2011
Registry last updated: Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed