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

Ospedale Misericordia e Dolce

Status and phase: Completed; Phase 4

Conditions: Stable Angina

Treatments: Drug: atorvastatin and clopidogrel; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01335048

6332011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Atorvastatin-Clopidogrel group

Experimental group

Description:

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

Treatment:

Drug: atorvastatin and clopidogrel

Clopidogrel group

Active Comparator group

Description:

Patients who receive clopidogrel 150 mg daily

Treatment:

Drug: Clopidogrel