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Statin Therapy In Atrial Refractoriness and Reperfusion Injury

NCT01780740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-08-07

No results posted yet for this study

Summary

Patients with coronary artery disease are often prescribed drugs called statins because research has shown that, by lowering cholesterol, they reduce the risk of having a heart attack or other complications in the long-term. Experimental studies have suggested that statins may also have rapid anti-inflammatory, anti-oxidant and anti arrhythmic actions; however, whether these effects are of any benefit to patients remains to be proven. The purpose of STARR trial (Statin Therapy in Atrial Refractoriness and Reperfusion injury) is to evaluate whether a short course of a commonly used statin (atorvastatin, 80 mg once a day) decreases inflammation and stabilises electrical properties of the upper chamber of the heart in the post operative period of patients undergoing cardiac surgery on the heart-lung machine either for valve replacement and/or coronary artery bypass grafting. It will also examine whether this treatment can protect the heart from sustaining tissue damage when blood supply is restored after a period of ischaemia during the course of the surgery.In addition it will also explore the impact of this intervention on biology of the vessels used for bypass surgery and the fat tissue in the vicinity of the heart \& blood vessels.

Conditions

  • Disorder; Heart, Functional, Postoperative, Cardiac Surgery
  • Cardiac Insufficiency Following Cardiac Surgery
  • Atrial Fibrillation
  • Ischaemia-reperfusion Injury

Interventions

DRUG

Atorvastatin

Atorvastatin (80 mg od) started not earlier than 6 days before surgery and continued until the 5th post-operative day included;

DRUG

Placebo

Placebo started not earlier than 6 days before surgery and continued until the 5th post-operative day included;

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Prof.Barbara Casadei, MD.DPhil.FRCP · Department of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford

  • Dr.Raja Jayaram, MD · Department of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01780740 on ClinicalTrials.gov