NCT01870804

Brief Summary

The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
760

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

May 30, 2013

Last Update Submit

October 5, 2016

Conditions

Acute Coronary Syndrome

Keywords

StatinsContrast-Induced Acute Kidney InjuryPeriprocedural Myocardial Damage

Outcome Measures

Primary Outcomes (1)

  • Contrast Induced-Acute Kidney Injury

    Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure

    72 hours

Secondary Outcomes (5)

  • Renal function at 30 days

    30 days after discharge

  • Cardiovascular and renal outcome

    30 days, 6 months, 12 months

  • Anti-inflammatory effect of rosuvastatin and atorvastatin

    On admission (baseline), at discharge (after 5 days) & at 30 days

  • Lipid-modulatory effects of atorvastatin and rosuvastatin

    On admission (baseline), at discharge (after 5 days) & at 30 days

  • Myocardial Damage

    During hospitalization (average 5 days)

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin (40 mg on-admission followed by 20 mg/day) until discharge; then 20 mg/day (10 mg/day if creatinine clearance \< 30 ml/min)

Drug: Rosuvastatin

Atorvastatin

ACTIVE COMPARATOR

atorvastatin (80 mg on-admission followed by 40 mg/day before and after discharge)

Drug: Atorvastatin

Interventions

RosuvastatinDRUG
Rosuvastatin
AtorvastatinDRUG
Atorvastatin

Eligibility Criteria

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

You may qualify if:

  • All consecutive statin-naive patients with non ST-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment

You may not qualify if:

  • Current statin treatment
  • High-risk features warranting emergency coronary angiography (within 2 hours)
  • Acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl
  • Severe comorbidities which precluded early invasive strategy
  • Contraindications to statin treatment
  • Contrast media administration within the last 10 days
  • Pregnancy
  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Division, Prato Hospital

Prato, Prato, 59100, Italy

Location

Related Publications (1)

  • Toso A, Leoncini M, Maioli M, Tropeano F, Villani S, Bellandi F. A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study. Cardiorenal Med. 2020;10(5):288-301. doi: 10.1159/000506857. Epub 2020 May 20.

    PMID: 32434204DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Anna Toso, MD

    Prato Hospital, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 6, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

IT(1)