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

Nephropathy Clinical Trial

— CLEAR-CIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737319
• Other study ID #: IDPC3851
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2016
• Last updated: April 12, 2016
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Nephropathy

Intervention

Drug:
• Rosuvastatin
40 mg of rosuvastatin before angioplasty

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours	No
Secondary	Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.	Death, myocardial infarction or kidney insufficiency	48 hours	Yes