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

January 24, 2012 updated by: Toso Anna, Ospedale Misericordia e Dolce
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Prato, Italy, 59100
        • Cardiology Department, Ospedale Misericordia e Dolce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
pre-PCI, 7 days and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6332011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Angina

Clinical Trials on atorvastatin and clopidogrel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe