NCT01185938

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

2.2 years

First QC Date

August 3, 2010

Last Update Submit

October 18, 2012

Conditions

Acute Coronary Syndrome

Keywords

statinCINperiprocedural damage

Outcome Measures

Primary Outcomes (1)

  • Incidence of contrast-induced nephropathy in patients with Acute Coronary Syndrome treated with rosuvastatin versus control

    3 days

Secondary Outcomes (3)

  • Peak levels and curve areas of myocardial necrosis markers measured throughout the hospitalization period.

    5 days (average)

  • Distribution of peripheral lymphocyte populations at the entry and at discharge

    5 days (average)

  • Incidence of clinical composite outcome (death, myocardial infarction, urgent revascularization, dialysis and stroke).

    30 days and 6 months

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR
Drug: Rosuvastatin

Control

NO INTERVENTION

Interventions

RosuvastatinDRUG

One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.

Rosuvastatin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • inability to provide consent
  • pregnancy or lactation
  • intolerance to statins
  • therapy with other lipid lowering drugs
  • acute or chronic liver disease
  • chronic muscle disease
  • acute renal failure or chronic renal failure stage IV
  • neoplastic
  • exposure to iodinated contrast medium in the previous 10 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Division, Prato Hospital

Prato, Prato, 59100, Italy

Location

Related Publications (3)

  • Toso A, Leoncini M, Maioli M, Tropeano F, Di Vincenzo E, Villani S, Bellandi F. Relationship between inflammation and benefits of early high-dose rosuvastatin on contrast-induced nephropathy in patients with acute coronary syndrome: the pathophysiological link in the PRATO-ACS study (Protective Effect of Rosuvastatin and Antiplatelet Therapy on Contrast-Induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention). JACC Cardiovasc Interv. 2014 Dec;7(12):1421-9. doi: 10.1016/j.jcin.2014.06.023.

    PMID: 25523533DERIVED

  • Leoncini M, Toso A, Maioli M, Tropeano F, Badia T, Villani S, Bellandi F. Early high-dose rosuvastatin and cardioprotection in the protective effect of rosuvastatin and antiplatelet therapy on contrast-induced acute kidney injury and myocardial damage in patients with acute coronary syndrome (PRATO-ACS) study. Am Heart J. 2014 Nov;168(5):792-7. doi: 10.1016/j.ahj.2014.08.005. Epub 2014 Aug 10.

    PMID: 25440809DERIVED

  • Leoncini M, Toso A, Maioli M, Tropeano F, Villani S, Bellandi F. Early high-dose rosuvastatin for contrast-induced nephropathy prevention in acute coronary syndrome: Results from the PRATO-ACS Study (Protective Effect of Rosuvastatin and Antiplatelet Therapy On contrast-induced acute kidney injury and myocardial damage in patients with Acute Coronary Syndrome). J Am Coll Cardiol. 2014 Jan 7-14;63(1):71-9. doi: 10.1016/j.jacc.2013.04.105. Epub 2013 Sep 26.

    PMID: 24076283DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Anna Toso, MD

    Misericordia e Dolce, Prato Hospital, Cardiology Unit

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 20, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

October 19, 2012

Record last verified: 2012-10

Locations

IT(1)