Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity
ACHIDO
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
April 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 26, 2012
January 1, 2012
8 months
April 11, 2011
January 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Atorvastatin-Clopidogrel group
EXPERIMENTALPatients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day
Clopidogrel group
ACTIVE COMPARATORPatients who receive clopidogrel 150 mg daily
Interventions
Atorvastatin 80 mg daily + clopidogrel 150 mg daily
Eligibility Criteria
You may qualify if:
- Stable angina
- candidates to drug eluting stent implantation
- High on-treatment platelet reactivity according to a point-of-care platelet function test
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology Department, Ospedale Misericordia e Dolce
Prato, 59100, Italy
Related Publications (1)
Leoncini M, Toso A, Maioli M, Angiolillo DJ, Giusti B, Marcucci R, Abbate R, Bellandi F. High-dose atorvastatin on the pharmacodynamic effects of double-dose clopidogrel in patients undergoing percutaneous coronary interventions: The ACHIDO (Atorvastatin and Clopidogrel HIgh DOse in stable patients with residual high platelet activity) study. JACC Cardiovasc Interv. 2013 Feb;6(2):169-79. doi: 10.1016/j.jcin.2012.09.013.
PMID: 23428009DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Leoncini, MD
Ospedale Misericordia e Dolce, Prato
- PRINCIPAL INVESTIGATOR
Anna Toso, MD
Ospedale Misericordia e Dolce, Prato
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 11, 2011
First Posted
April 13, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
January 26, 2012
Record last verified: 2012-01