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

Stable Angina Clinical Trial

— ACHIDO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335048
• Other study ID #: 6332011
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2011
• Last updated: January 24, 2012
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Ospedale Misericordia e Dolce
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Intervention

Drug:
• atorvastatin and clopidogrel
Atorvastatin 80 mg daily + clopidogrel 150 mg daily
• Clopidogrel
Clopidogrel 150 mg daily

Locations

Country	Name	City	State
Italy	Cardiology Department, Ospedale Misericordia e Dolce	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in on-treatment platelet reactivity at 7 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).	pre-PCI, 7 days and 30 days	No