Statin Contrast Induced Nephropathy Prevention (PRATO-ACS)

October 18, 2012 updated by: Anna Toso, Centro Cardiopatici Toscani

Protective Effect of Rosuvastatin and Antiplatelet Therapy On Contrast-induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention; PRATO-ACS Trial

This open-label study, prospective, randomized trial evaluating the acute (in-hospital) pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with acute coronary syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this study is to determine whether, in patients with acute coronary syndromes not taking statins in chronic administration, high doses of a hydrophilic statin (rosuvastatin) administered before coronary angiography and/or angioplasty, may exert a renal-protective effect by reducing the incidence of contrast nephropathy. Contrast induced nephropathy is defined as increased values of creatinine >= 0.3 mg/dl from baseline values, within 72 hours after contrast medium exposure.

Secondary end points: 1) verify if short-term (<48 hours)statin administration reduces the peak levels and the curve areas of markers of myocardial necrosis throughout the hospitalization period and if reduces the occurrence of periprocedural infarction. Biochemical markers (quantitative creatine kinase-MB (CK-MB) mass and Troponin I) are measured at admission and at 6, 12, and 24 hours during the first day then once daily, immediately before angiography, and 24 hours thereafter. In patients who underwent coronary angioplasty (PCI), biochemical markers were measured at 12 and 24 hours after the procedure. Data were fitted, peak values and curve areas calculated; the occurrence of periprocedural infarction was defined as a CK-MB mass elevation more than three times the upper limit of normal within 24 hours after PCI. 2) determine the distribution of peripheral lymphocytic populations at the entry and at discharge using the flow cytometric analysis; 3) analyze the clinical composite outcome of death, myocardial infarction, urgent revascularization, dialysis and stroke at 30 days and 6 months.

Study Type

Interventional

Enrollment (Actual)

500

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 Division, Prato Hospital

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

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Are eligible for the study all patients admitted to CCU for Acute Coronary Syndrome without ST elevation (NSTEMI) candidates for early invasive strategy (coronary angiography within 48 hours from the admission) and without previous therapy with statins.

Exclusion Criteria:

  1. inability to provide consent
  2. pregnancy or lactation
  3. intolerance to statins
  4. therapy with other lipid lowering drugs
  5. acute or chronic liver disease
  6. chronic muscle disease
  7. acute renal failure or chronic renal failure stage IV
  8. neoplastic
  9. exposure to iodinated contrast medium in the previous 10 days

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Rosuvastatin
Drug: Rosuvastatin
One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak levels and curve areas of myocardial necrosis markers measured throughout the hospitalization period.
Time Frame: 5 days (average)
Quantitative creatine kinase-MB (CK-MB) mass and cTn I were measured at admission and at 6, 12, and 24 hours during the first day then once daily, immediately before angiography, and 24 hours thereafter. In patients who underwent angioplasty, biochemical markers were measured at 12 and 24 hours after procedure.
5 days (average)
Distribution of peripheral lymphocyte populations at the entry and at discharge
Time Frame: 5 days (average)
Comparison between groups for the distribution of peripheral lymphocyte sub-population evaluated bu Flow Cytometric Analysis at the admission and at discharge.
5 days (average)
Incidence of clinical composite outcome (death, myocardial infarction, urgent revascularization, dialysis and stroke).
Time Frame: 30 days and 6 months
Clinical follow-up at 30 days and 6 month after the hospitalization for the Acute Coronary Syndrome.
30 days and 6 months

Collaborators and Investigators

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

Sponsor

Centro Cardiopatici Toscani

Investigators

  • Study Chair: Anna Toso, MD, Misericordia e Dolce, Prato Hospital, Cardiology Unit

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

July 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 552010

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.

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