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Paroxysmal Atrial FibrillationPhase 4NCT02502110

Study of Statin for Reduction of Postoperative Paroxysmal Atrial Fibrillation

A Phase 4 study testing rosuvastatin in people with Paroxysmal Atrial Fibrillation, run by The Third Xiangya Hospital of Central South University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
346 participants
Where
No sites listed yet
Study dates
Aug 2015to Jun 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet.

zhihui zhang, ViceDirector contact

+86-13687338286

zhangzhihui0869@163.com

About this study

Official title: 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.

Read the 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.

Being tested
rosuvastatin
Keywords
Atrial Fibrillation, statin, radiofrequency ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rosuvastatinDrug

    Also called crestor

    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.

Study groups in NCT02502110
Study groupRoleWhat they receive
rosuvastatin 20mg/dayExperimentalTo receive oral rosuvastatin 20mg/day and regular therapy from 7 days before ablation and last for 3 months.
Receives: Drug: rosuvastatin
blank controlNo interventionRegular 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. the AF recurrence rate

    Measured: within 90 days after radiofrequency catheter ablation.

Secondary outcomes (5)
  1. the AF recurrence rate

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

  2. The inflammatory markers (white blood cell count)

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

  3. The inflammatory markers (hs-CRP)

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

  4. The inflammatory markers (IL-6)

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

  5. The inflammatory markers (TNF-α)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionMar 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
346 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02502110
Sponsor's protocol ID
ISSCRES0175
Status last verified
Jul 2015
First submitted
16 Jul 2015
Last updated
21 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20802247
  • 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.

    PubMed 17599958
  • 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.

    PubMed 19559266
  • 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.

    PubMed 17888965
  • 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.

    PubMed 12960937
  • 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.

    PubMed 20006465
  • 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.

    PubMed 15312874
  • 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.

    PubMed 15133358
  • 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.

    PubMed 20339034
  • 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.

    PubMed 18834466
  • 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.

    PubMed 10769273
  • 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.

    PubMed 15975993
  • 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.

    PubMed 11854129
  • 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.

    PubMed 14675569
  • 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.

    PubMed 20624624

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosuvastatin in people with Paroxysmal Atrial Fibrillation, run by The Third Xiangya Hospital of Central South University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact zhihui zhang, ViceDirector (+86-13687338286, zhangzhihui0869@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the AF recurrence rate (time frame: within 90 days after radiofrequency catheter ablation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02502110, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.

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