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A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN). (CLEAR-CIN)

Primary Purpose

Nephropathy

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Rosuvastatin

About this trial

This is an interventional prevention trial for Nephropathy focused on measuring Contrast,nephropathy, angioplasty, stable coronary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

chronic statin use
positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
elective angioplasty.

Exclusion Criteria:

non-statin therapy
any presentation of ACS within 24 hours before the time of randomization
current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine
renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine > 3.0 mg/dl).

Sites / Locations

Instituto Dante Pazzanese de Cardiologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rosuvastatin

Control

Arm Description

40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.

Use of standard therapy in elective angioplasty.

Outcomes

Primary Outcome Measures

Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline

Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline

Secondary Outcome Measures

Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.

Death, myocardial infarction or kidney insufficiency

Full Information

NCT ID

NCT02737319

First Posted

April 8, 2016

Last Updated

April 12, 2016

Sponsor

University of Sao Paulo

Collaborators

Instituto Dante Pazzanese de Cardiologia

1. Study Identification

Unique Protocol Identification Number

NCT02737319

Brief Title

A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).

Acronym

CLEAR-CIN

Official Title

A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

Collaborators

Instituto Dante Pazzanese de Cardiologia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.

Detailed Description

Patients with stable coronary artery disease already taking chronic statin undergoing elective angioplasty are at risk for contrast-medium-induced nephropathy because there are specified risk factors as age more than 75 years, chronic renal insufficiency, diabetes, use of contrast and the lack of effective prophylaxis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nephropathy

Keywords

Contrast,nephropathy, angioplasty, stable coronary

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

493 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rosuvastatin

Arm Type

Experimental

Arm Description

40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Use of standard therapy in elective angioplasty.

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Group 1

Intervention Description

40 mg of rosuvastatin before angioplasty

Primary Outcome Measure Information:

Title

Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline

Description

Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.

Description

Death, myocardial infarction or kidney insufficiency

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: chronic statin use positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography elective angioplasty. Exclusion Criteria: non-statin therapy any presentation of ACS within 24 hours before the time of randomization current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine > 3.0 mg/dl).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kleber Bomfim A Martins, MD, PhD

Organizational Affiliation

Instituto Date Pazzanese de Cardiologia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Dante Pazzanese de Cardiologia

City

São Paulo

ZIP/Postal Code

04012-909

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).

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