Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation

July 20, 2015 updated by: The Third Xiangya Hospital of Central South University

The Study of Rosuvastatin for Reduction of Postoperative Paroxysmal Atrial Fibrillation in Patient Undergoing Radiofrequency Catheter Ablation

The study will select all recruited patients with paroxysmal atrial fibrillation will be randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before ablation and last for 3 months. To observe the early relapse of atrial fibrillation and the changes of white blood cell count, hs-C reactive protein (CRP), interleukin (IL)-6 and tumor necrosis factor (TNF)-α, and the changes of safety indicators .

This study assumes that the early atrial fibrillation (AF) recurrence will be decreased in patients with paroxysmal AF if rosuvastatin 20mg/d is received from 7 days before surgery in these patients who plan to undergo radiofrequency catheter ablation for consecutive 3 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, open-label, multi-centers, parallel-control study to explore whether rosuvastatin 20mg/d could decrease early AF recurrence in patients with paroxysmal AF after radiofrequency catheter ablation. 346 patients with paroxysmal AF are planned to be enrolled. The patients are randomized to receive oral rosuvastatin 20mg/d or control therapy from 7 days before operation and last for 3 months. The early AF recurrence within 90 days after ablation and the changes of 4 inflammatory markers including white blood cell count, hs-CRP, IL-6 and TNF-α and safety indicators will be observed. The study is aim to evaluate the efficacy and safety of rosuvastatin on decreasing early recurrence in patients with paroxysmal AF and discuss its mechanisms of action.

Study Type

Interventional

Enrollment (Anticipated)

346

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures;
  2. Age from 18 to 75 years old, male or female;
  3. The course of paroxysmal AF is more than 3 months and confirmed by ECG;
  4. Plan to undergo radiofrequency catheter ablation

Exclusion Criteria:

  1. Concomitant with serious organic heart disease such as valvular heart diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardial infarction and unstable angina pectoris;
  2. Concomitant with sinoatrial node functional disorder and (or) atrioventricular block;
  3. Acute cerebral apoplexy or contraindication of anticoagulant;
  4. Thyroid function abnormality;
  5. Accepted radiofrequency catheter ablation (RFCA) previously;
  6. Being receiving other statins;
  7. Be allergic to statins;
  8. Pregnancy or women during lactation period;
  9. Be not aligning to treatment or follow-up due to mental disorders or other reasons;
  10. Be with myopathy or active hepatopathy including agnogenic persistent elevation of serum transaminase and any serum transaminase being over 3 times of upper limit of normal;
  11. Be with serious renal dysfunction (creatinine≥3 mg/dL);
  12. Need steroid or non-steroid anti-inflammatory drugs to treat inflammation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: rosuvastatin 20mg/day
To receive oral rosuvastatin 20mg/day and regular therapy from 7 days before ablation and last for 3 months.
Drug: rosuvastatin
All recruited patients with paroxysmal atrial fibrillation will be randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before ablation and last for 3 months.
Other Names:
  • crestor
NO_INTERVENTION: blank control
Regular therapy from 7 days before ablation and last for 3 months. Regular medicines used for AF includes warfarin, metoprolol sustained release tablet, amiodarone, perindopril and irbesartan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the AF recurrence rate
Time Frame: within 90 days after radiofrequency catheter ablation.
within 90 days after radiofrequency catheter ablation.

Secondary Outcome Measures

Outcome Measure
Time Frame
the AF recurrence rate
Time Frame: at 24 hours, 72 hours, 1month, 2 months and 3 months after operation
at 24 hours, 72 hours, 1month, 2 months and 3 months after operation
The inflammatory markers (white blood cell count)
Time Frame: at 24 hours, 72 hours, and 3 months after operation
at 24 hours, 72 hours, and 3 months after operation
The inflammatory markers (hs-CRP)
Time Frame: at 24 hours, 72 hours, and 3 months after operation
at 24 hours, 72 hours, and 3 months after operation
The inflammatory markers (IL-6)
Time Frame: at 24 hours, 72 hours, and 3 months after operation
at 24 hours, 72 hours, and 3 months after operation
The inflammatory markers (TNF-α)
Time Frame: at 24 hours, 72 hours, and 3 months after operation
at 24 hours, 72 hours, and 3 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: zhihui zhang, ViceDirector, Third Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (ESTIMATE)

July 20, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSCRES0175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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