Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation

NCT02502110 | Unknown Phase 4 DMC

• 1 other identifier: ISSCRES0175
• Study Type: interventional
• Target: 346
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial Fibrillation; statin; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• the AF recurrence rate

  within 90 days after radiofrequency catheter ablation.

Secondary Outcomes (5)

• the AF recurrence rate

  at 24 hours, 72 hours, 1month, 2 months and 3 months after operation

• The inflammatory markers (white blood cell count)

  at 24 hours, 72 hours, and 3 months after operation

• The inflammatory markers (hs-CRP)

  at 24 hours, 72 hours, and 3 months after operation

• The inflammatory markers (IL-6)

  at 24 hours, 72 hours, and 3 months after operation

• The inflammatory markers (TNF-α)

  at 24 hours, 72 hours, and 3 months after operation

Study Arms (2)

rosuvastatin 20mg/day

EXPERIMENTAL

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

Drug: rosuvastatin

blank control

NO INTERVENTION

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.

Interventions

rosuvastatin DRUG

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.

Also known as: crestor

rosuvastatin 20mg/day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Related Publications (20)

• 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.

  PMID: 20802247 BACKGROUND

• 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.

  PMID: 17599958 BACKGROUND

• 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.

  PMID: 19559266 BACKGROUND

• 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.

  PMID: 17888965 BACKGROUND

• 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.

  PMID: 12960937 BACKGROUND

• 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.

  PMID: 20006465 BACKGROUND

• 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.

  PMID: 15312874 BACKGROUND

• 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.

  PMID: 15133358 BACKGROUND

• 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.

  PMID: 20339034 BACKGROUND

• 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.

  PMID: 18834466 BACKGROUND

• 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.

  PMID: 10769273 BACKGROUND

• 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.

  PMID: 15975993 BACKGROUND

• 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.

  PMID: 11854129 BACKGROUND

• 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.

  PMID: 14675569 BACKGROUND

• 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.

  PMID: 20624624 BACKGROUND

• 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.

  PMID: 16679090 BACKGROUND

• 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.

  PMID: 14636918 BACKGROUND

• 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.

  PMID: 19202157 BACKGROUND

• 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.

  PMID: 17000910 BACKGROUND

• 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.

  PMID: 19717850 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• zhihui zhang, ViceDirector

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhihui zhang, ViceDirector

CONTACT

+86-13687338286; zhangzhihui0869@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 20, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 21, 2015

Record last verified: 2015-07