Clinical trial NCT02502110: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial Fibrillation
statin
radiofrequency ablation
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the AF recurrence rate
timeFrame: within 90 days after radiofrequency catheter ablation.
Secondary outcomes:
measure: the AF recurrence rate
timeFrame: at 24 hours, 72 hours, 1month, 2 months and 3 months after operation
measure: The inflammatory markers (white blood cell count)
timeFrame: at 24 hours, 72 hours, and 3 months after operation
measure: The inflammatory markers (hs-CRP)
timeFrame: at 24 hours, 72 hours, and 3 months after operation
measure: The inflammatory markers (IL-6)
timeFrame: at 24 hours, 72 hours, and 3 months after operation
measure: The inflammatory markers (TNF-α)
timeFrame: at 24 hours, 72 hours, and 3 months after operation
Other outcomes:
Locations:
Study officials:
affiliation: Third Xiangya Hospital of Central South University
name: zhihui zhang, ViceDirector
role: PRINCIPAL_INVESTIGATOR
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