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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Toso Anna, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT01335048
First received: April 11, 2011
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Stable Angina
 Drug: atorvastatin and clopidogrel
Drug: Clopidogrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedale Misericordia e Dolce:

Primary Outcome Measures:
  • Change from baseline in on-treatment platelet reactivity at 7 and 30 days [ Time Frame: pre-PCI, 7 days and 30 days ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 50
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335048

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

No publications provided by Ospedale Misericordia e Dolce

Additional 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
Study First Received: April 11, 2011
Last Updated: January 24, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale Misericordia e Dolce:
Clopidogrel
Statins
Platelet reactivity
Point-of-care platelet function test

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Atorvastatin
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 18, 2013