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Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
The Third Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial Fibrillation, statin, radiofrequency ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    rosuvastatin 20mg/day

    blank control

    Arm Description

    To receive oral rosuvastatin 20mg/day and regular therapy from 7 days before ablation and last for 3 months.

    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.

    Outcomes

    Primary Outcome Measures

    the AF recurrence rate

    Secondary Outcome Measures

    the AF recurrence rate
    The inflammatory markers (white blood cell count)
    The inflammatory markers (hs-CRP)
    The inflammatory markers (IL-6)
    The inflammatory markers (TNF-α)

    Full Information

    First Posted
    July 16, 2015
    Last Updated
    July 20, 2015
    Sponsor
    The Third Xiangya Hospital of Central South University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02502110
    Brief Title
    Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation
    Official Title
    The Study of Rosuvastatin for Reduction of Postoperative Paroxysmal Atrial Fibrillation in Patient Undergoing Radiofrequency Catheter Ablation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Third Xiangya Hospital of Central South University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paroxysmal Atrial Fibrillation
    Keywords
    Atrial Fibrillation, statin, radiofrequency ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    346 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rosuvastatin 20mg/day
    Arm Type
    Experimental
    Arm Description
    To receive oral rosuvastatin 20mg/day and regular therapy from 7 days before ablation and last for 3 months.
    Arm Title
    blank control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    rosuvastatin
    Other Intervention Name(s)
    crestor
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    the AF recurrence rate
    Time Frame
    within 90 days after radiofrequency catheter ablation.
    Secondary Outcome Measure Information:
    Title
    the AF recurrence rate
    Time Frame
    at 24 hours, 72 hours, 1month, 2 months and 3 months after operation
    Title
    The inflammatory markers (white blood cell count)
    Time Frame
    at 24 hours, 72 hours, and 3 months after operation
    Title
    The inflammatory markers (hs-CRP)
    Time Frame
    at 24 hours, 72 hours, and 3 months after operation
    Title
    The inflammatory markers (IL-6)
    Time Frame
    at 24 hours, 72 hours, and 3 months after operation
    Title
    The inflammatory markers (TNF-α)
    Time Frame
    at 24 hours, 72 hours, and 3 months after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Age from 18 to 75 years old, male or female; The course of paroxysmal AF is more than 3 months and confirmed by ECG; Plan to undergo radiofrequency catheter ablation Exclusion Criteria: Concomitant with serious organic heart disease such as valvular heart diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardial infarction and unstable angina pectoris; Concomitant with sinoatrial node functional disorder and (or) atrioventricular block; Acute cerebral apoplexy or contraindication of anticoagulant; Thyroid function abnormality; Accepted radiofrequency catheter ablation (RFCA) previously; Being receiving other statins; Be allergic to statins; Pregnancy or women during lactation period; Be not aligning to treatment or follow-up due to mental disorders or other reasons; 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; Be with serious renal dysfunction (creatinine≥3 mg/dL); Need steroid or non-steroid anti-inflammatory drugs to treat inflammation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zhihui zhang, ViceDirector
    Phone
    +86-13687338286
    Email
    zhangzhihui0869@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    zhihui zhang, ViceDirector
    Organizational Affiliation
    Third Xiangya Hospital of Central South University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation

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