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
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial Fibrillation, statin, radiofrequency ablation
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.
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
NCT ID
NCT02502110
First Posted
July 16, 2015
Last Updated
July 20, 2015
Sponsor
The Third Xiangya Hospital of Central South University
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
Citations:
PubMed Identifier
20802247
Citation
European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available. Erratum In: Eur Heart J. 2011 May;32(9):1172.
Results Reference
background
PubMed Identifier
17599958
Citation
Neuman RB, Bloom HL, Shukrullah I, Darrow LA, Kleinbaum D, Jones DP, Dudley SC Jr. Oxidative stress markers are associated with persistent atrial fibrillation. Clin Chem. 2007 Sep;53(9):1652-7. doi: 10.1373/clinchem.2006.083923. Epub 2007 Jun 28.
Results Reference
background
PubMed Identifier
19559266
Citation
Anselmi A, Possati G, Gaudino M. Postoperative inflammatory reaction and atrial fibrillation: simple correlation or causation? Ann Thorac Surg. 2009 Jul;88(1):326-33. doi: 10.1016/j.athoracsur.2009.01.031.
Results Reference
background
PubMed Identifier
17888965
Citation
Ramlawi B, Otu H, Mieno S, Boodhwani M, Sodha NR, Clements RT, Bianchi C, Sellke FW. Oxidative stress and atrial fibrillation after cardiac surgery: a case-control study. Ann Thorac Surg. 2007 Oct;84(4):1166-72; discussion 1172-3. doi: 10.1016/j.athoracsur.2007.04.126.
Results Reference
background
PubMed Identifier
12960937
Citation
Korantzopoulos P, Kolettis T, Siogas K, Goudevenos J. Atrial fibrillation and electrical remodeling: the potential role of inflammation and oxidative stress. Med Sci Monit. 2003 Sep;9(9):RA225-9.
Results Reference
background
PubMed Identifier
20006465
Citation
Chimenti C, Russo MA, Carpi A, Frustaci A. Histological substrate of human atrial fibrillation. Biomed Pharmacother. 2010 Mar;64(3):177-83. doi: 10.1016/j.biopha.2009.09.017. Epub 2009 Nov 18.
Results Reference
background
PubMed Identifier
15312874
Citation
Kottkamp H, Tanner H, Kobza R, Schirdewahn P, Dorszewski A, Gerds-Li JH, Carbucicchio C, Piorkowski C, Hindricks G. Time courses and quantitative analysis of atrial fibrillation episode number and duration after circular plus linear left atrial lesions: trigger elimination or substrate modification: early or delayed cure? J Am Coll Cardiol. 2004 Aug 18;44(4):869-77. doi: 10.1016/j.jacc.2004.04.049.
Results Reference
background
PubMed Identifier
15133358
Citation
Lee SH, Tai CT, Hsieh MH, Tsai CF, Lin YK, Tsao HM, Yu WC, Huang JL, Ueng KC, Cheng JJ, Ding YA, Chen SA. Predictors of early and late recurrence of atrial fibrillation after catheter ablation of paroxysmal atrial fibrillation. J Interv Card Electrophysiol. 2004 Jun;10(3):221-6. doi: 10.1023/B:JICE.0000026915.02503.92.
Results Reference
background
PubMed Identifier
20339034
Citation
Sawhney N, Anousheh R, Chen W, Feld GK. Circumferential pulmonary vein ablation with additional linear ablation results in an increased incidence of left atrial flutter compared with segmental pulmonary vein isolation as an initial approach to ablation of paroxysmal atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Jun;3(3):243-8. doi: 10.1161/CIRCEP.109.924878. Epub 2010 Mar 25.
Results Reference
background
PubMed Identifier
18834466
Citation
McCabe JM, Smith LM, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Scheinman MM, Olgin JE, Marcus GM. Protracted CRP elevation after atrial fibrillation ablation. Pacing Clin Electrophysiol. 2008 Sep;31(9):1146-51. doi: 10.1111/j.1540-8159.2008.01155.x.
Results Reference
background
PubMed Identifier
10769273
Citation
Kothe H, Dalhoff K, Rupp J, Muller A, Kreuzer J, Maass M, Katus HA. Hydroxymethylglutaryl coenzyme A reductase inhibitors modify the inflammatory response of human macrophages and endothelial cells infected with Chlamydia pneumoniae. Circulation. 2000 Apr 18;101(15):1760-3. doi: 10.1161/01.cir.101.15.1760.
Results Reference
background
PubMed Identifier
15975993
Citation
Engelmann MD, Svendsen JH. Inflammation in the genesis and perpetuation of atrial fibrillation. Eur Heart J. 2005 Oct;26(20):2083-92. doi: 10.1093/eurheartj/ehi350. Epub 2005 Jun 23.
Results Reference
background
PubMed Identifier
11854129
Citation
Hayashidani S, Tsutsui H, Shiomi T, Suematsu N, Kinugawa S, Ide T, Wen J, Takeshita A. Fluvastatin, a 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor, attenuates left ventricular remodeling and failure after experimental myocardial infarction. Circulation. 2002 Feb 19;105(7):868-73. doi: 10.1161/hc0702.104164.
Results Reference
background
PubMed Identifier
14675569
Citation
Young-Xu Y, Jabbour S, Goldberg R, Blatt CM, Graboys T, Bilchik B, Ravid S. Usefulness of statin drugs in protecting against atrial fibrillation in patients with coronary artery disease. Am J Cardiol. 2003 Dec 15;92(12):1379-83. doi: 10.1016/j.amjcard.2003.08.040.
Results Reference
background
PubMed Identifier
20624624
Citation
Kourliouros A, Valencia O, Hosseini MT, Mayr M, Sarsam M, Camm J, Jahangiri M. Preoperative high-dose atorvastatin for prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. J Thorac Cardiovasc Surg. 2011 Jan;141(1):244-8. doi: 10.1016/j.jtcvs.2010.06.006. Epub 2010 Jul 10.
Results Reference
background
PubMed Identifier
16679090
Citation
Ozaydin M, Varol E, Aslan SM, Kucuktepe Z, Dogan A, Ozturk M, Altinbas A. Effect of atorvastatin on the recurrence rates of atrial fibrillation after electrical cardioversion. Am J Cardiol. 2006 May 15;97(10):1490-3. doi: 10.1016/j.amjcard.2005.11.082. Epub 2006 Mar 29.
Results Reference
background
PubMed Identifier
14636918
Citation
Siu CW, Lau CP, Tse HF. Prevention of atrial fibrillation recurrence by statin therapy in patients with lone atrial fibrillation after successful cardioversion. Am J Cardiol. 2003 Dec 1;92(11):1343-5. doi: 10.1016/j.amjcard.2003.08.023.
Results Reference
background
PubMed Identifier
19202157
Citation
Almroth H, Hoglund N, Boman K, Englund A, Jensen S, Kjellman B, Tornvall P, Rosenqvist M. Atorvastatin and persistent atrial fibrillation following cardioversion: a randomized placebo-controlled multicentre study. Eur Heart J. 2009 Apr;30(7):827-33. doi: 10.1093/eurheartj/ehp006. Epub 2009 Feb 6.
Results Reference
background
PubMed Identifier
17000910
Citation
Patti G, Chello M, Candura D, Pasceri V, D'Ambrosio A, Covino E, Di Sciascio G. Randomized trial of atorvastatin for reduction of postoperative atrial fibrillation in patients undergoing cardiac surgery: results of the ARMYDA-3 (Atorvastatin for Reduction of MYocardial Dysrhythmia After cardiac surgery) study. Circulation. 2006 Oct 3;114(14):1455-61. doi: 10.1161/CIRCULATIONAHA.106.621763. Epub 2006 Sep 25.
Results Reference
background
PubMed Identifier
19717850
Citation
Maggioni AP, Fabbri G, Lucci D, Marchioli R, Franzosi MG, Latini R, Nicolosi GL, Porcu M, Cosmi F, Stefanelli S, Tognoni G, Tavazzi L; GISSI-HF Investigators. Effects of rosuvastatin on atrial fibrillation occurrence: ancillary results of the GISSI-HF trial. Eur Heart J. 2009 Oct;30(19):2327-36. doi: 10.1093/eurheartj/ehp357. Epub 2009 Aug 30.
Results Reference
background
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Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation
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