NCT02113540

Brief Summary

As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

2.3 years

First QC Date

April 5, 2014

Last Update Submit

April 10, 2014

Conditions

Contrast Induced Nephropathy

Keywords

coronary angiographychronic stable anginaCIN

Outcome Measures

Primary Outcomes (1)

  • Contrast induced nephropathy (CIN) incidence

    CIN is determined as an increase in post-procedural serum creatinine of \> 0.5 mg/dl or \> 25% from baseline in the absence of any other causes

    48 hours after the procedure

Secondary Outcomes (1)

  • serum creatinine (Cr) level

    48 hours after the procedure

Study Arms (3)

placebo group

PLACEBO COMPARATOR

taking atorvastatin like placebo 12 hours before the procedure

long term statin group

NO INTERVENTION

taking atorvastatin for a long time before entering the study (their routine treatment)

preoperation statin group

EXPERIMENTAL

taking atorvastatin 12 hours before the procedure

Drug: Atorvastatin

Interventions

AtorvastatinDRUG
preoperation statin group

Eligibility Criteria

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

You may qualify if:

  • having chronic stable angina who were referred for coronary angiography
  • non-pregnant female subjects
  • no history of diabetes mellitus
  • no history of renal failure
  • no history of single kidney
  • no history of cardiogenic shock
  • no history of unstable angina
  • no history of myocardial infarction
  • no history of hypersensitivity to statins
  • no history of previous intravascular contrast injection during one month before admission

You may not qualify if:

  • glomerular filtration rate (GFR) \<60
  • cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Isfahan, Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Angina, Stable

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr peyman bidram

Study Record Dates

First Submitted

April 5, 2014

First Posted

April 14, 2014

Study Start

January 1, 2012

Primary Completion

May 1, 2014

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

IR(1)