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

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ClinicalTrials.gov Identifier: NCT01335048
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : January 26, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Stable Angina Drug: atorvastatin and clopidogrel Drug: Clopidogrel Phase 4

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity
Study Start Date : April 2011
Primary Completion Date : December 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Atorvastatin-Clopidogrel group
Patients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day
Drug: atorvastatin and clopidogrel
Atorvastatin 80 mg daily + clopidogrel 150 mg daily
Active Comparator: Clopidogrel group
Patients who receive clopidogrel 150 mg daily
Drug: Clopidogrel
Clopidogrel 150 mg daily

Outcome Measures

Primary Outcome Measures :
  1. 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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335048

Cardiology Department, Ospedale Misericordia e Dolce
Prato, Italy, 59100
Sponsors and Collaborators
Ospedale Misericordia e Dolce
Principal Investigator: Mario Leoncini, MD Ospedale Misericordia e Dolce, Prato
Principal Investigator: Anna Toso, MD Ospedale Misericordia e Dolce, Prato
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toso Anna, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT01335048     History of Changes
Other Study ID Numbers: 6332011
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Toso Anna, Ospedale Misericordia e Dolce:
Platelet reactivity
Point-of-care platelet function test

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents