NCT00770796

Brief Summary

In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

October 9, 2008

Last Update Submit

October 15, 2015

Conditions

Contrast Induced Nephropathy

Keywords

Contrast induced nephropathy

Outcome Measures

Primary Outcomes (1)

  • Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards

    within 5 days after contrast exposure

Secondary Outcomes (2)

  • Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration

    within 5 days after contrast agent administration

  • Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration

    1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Atorvastatin

ACTIVE COMPARATOR

80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

80 mg die

Atorvastatin
PlaceboDRUG
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with pre-angiographic estimated creatinine clearance \< 60 ml/min

You may not qualify if:

  • contrast medium administration within the previous 10 days
  • end-stage renal failure requiring dialysis
  • refusal to give informed consent
  • previous therapy with statin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Mauro Maioli, MD

    Ospedale Misericordia e Dolce, Prato

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

April 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 16, 2015

Record last verified: 2015-10