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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP) values in the blood.
Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative therapy has recently become possible.
There is growing evidence that inflammation may be involved in the pathogenesis of AF. CRP, a sensitive marker of systemic inflammation, is increased in patients with AF compared with patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new onset AF and with recurrence of AF after successful cardioversion. Clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against AF.
125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure.
Patients will have baseline lipids, CRP, endothelial function tests and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days |
|
| Placebo | Placebo Comparator | Placebo (dummy) tablet taken once daily by mouth for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 80 mg tablet taken by mouth daily for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months | Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group). | Baseline through 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Without Atrial Arrhythmia at 3 Months | Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter. | Baseline through 3 months |
| Change in Mean C-Reactive Protein Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Friedman, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14623805 | Background | Aviles RJ, Martin DO, Apperson-Hansen C, Houghtaling PL, Rautaharju P, Kronmal RA, Tracy RP, Van Wagoner DR, Psaty BM, Lauer MS, Chung MK. Inflammation as a risk factor for atrial fibrillation. Circulation. 2003 Dec 16;108(24):3006-10. doi: 10.1161/01.CIR.0000103131.70301.4F. Epub 2003 Nov 17. | |
| 16198844 | Background |
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847 patients were screened and of those, 567 were excluded, primarily because they were already receiving statin therapy (68%) and/or had known inflammatory disease (16%). 280 met entry criteria but 155 were not willing to participate. 125 were enrolled in the study.
Patients were enrolled in this trial between January 2008 and December 2009 at Mayo Clinic in Rochester, Minnesota (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days |
| FG001 | Placebo | Placebo (dummy) tablet taken once daily by mouth for 90 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days |
| BG001 | Placebo | Placebo (dummy) tablet taken once daily by mouth for 90 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months | Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group). | Intent-to-treat analysis population. | Posted | Number | Percentage of subjects | Baseline through 3 months |
|
Baseline to 3 months post ablation procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin | Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clot formation in left atrium during ablation procedure | Surgical and medical procedures | Non-systematic Assessment |
The population was restricted to patients who did not have an indication for statin treatment. The lack of transtelephonic or prolonged Holter monitoring likely resulted in underestimation of the rate of asymptomatic episodes of AF.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul A. Friedman, MD | Mayo Clinic | 507-255-2398 | friedman.paul@mayo.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo tablet taken by mouth once daily for 90 days |
|
|
| Baseline and 3 months |
| Change in Mean Quality of Life Score | A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group. | Baseline and 3 months |
| Change in Lipid Levels | The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated. | Baseline and 3 months |
| Malouf JF, Kanagala R, Al Atawi FO, Rosales AG, Davison DE, Murali NS, Tsang TS, Chandrasekaran K, Ammash NM, Friedman PA, Somers VK. High sensitivity C-reactive protein: a novel predictor for recurrence of atrial fibrillation after successful cardioversion. J Am Coll Cardiol. 2005 Oct 4;46(7):1284-7. doi: 10.1016/j.jacc.2005.06.053. |
| 17000910 | 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. |
| 15582310 | Background | Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062. |
| 21920481 | Result | Suleiman M, Koestler C, Lerman A, Lopez-Jimenez F, Herges R, Hodge D, Bradley D, Cha YM, Brady PA, Munger TM, Asirvatham SJ, Packer DL, Friedman PA. Atorvastatin for prevention of atrial fibrillation recurrence following pulmonary vein isolation: a double-blind, placebo-controlled, randomized trial. Heart Rhythm. 2012 Feb;9(2):172-8. doi: 10.1016/j.hrthm.2011.09.016. Epub 2011 Sep 13. |
| Withdrawal by Subject |
|
| AF returned after ablation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Paroxysmal Atrial Fibrillation | Paroxysmal atrial fibrillation is atrial fibrillation that comes and goes, starting and stopping suddenly. Not all patients experience this type of atrial fibrillation, therefore, the number reported for each group will differ from the number of overall participants per group. | Number | Participants |
|
| Duration of Atrial Fibrillation | Median | Full Range | Months |
|
| Years of Atrial Fibrillation | Mean | Standard Deviation | Years |
|
| Concomitant Conditions | Not all subjects had all concomitant medical conditions, therefore the number reported for each condition will not match the overall/total number of subjects per treatment group. | Number | Participants |
|
| Medication on admission | Not all subjects were taking all medications upon admission, therefore the number reported for each medication class will not match the overall/total number of subjects per treatment group. | Number | Participants |
|
| Antiarrhythmic drugs | Not all subjects were taking antiarrhythmic drugs upon admission, therefore the numbers reported will differ from the number of overall subjects in each treatment group. | Number | Participants |
|
| Echocardiographic parameter-LA diameter, long axis | LA = left atrium (chamber of heart) | Mean | Standard Deviation | millimeters |
|
| Echocardiographic parameter-LA volume index | Mean | Standard Deviation | cc/m^2 |
|
| Echocardiographic parameter-LVEF | LVEF= left ventricular ejection fraction, which is the volume of blood pumped out of the heart with each heartbeat. A normal LVEF ranges from 55-70%. A LVEF of 65, for example, means that 65% of the total amount of blood in the left ventricle is pumped out with each heartbeat. | Mean | Standard Deviation | Percentage |
|
| Procedural time | Mean | Standard Deviation | Minutes |
|
| Anatomical area of ablation | The catheter ablation procedure involves intentional destruction of left atrial (LA) tissue via radiofrequency energy and is used to treat atrial fibrillation (AF). Lesions often extend to the pericardium and pericardiac tissues, therefore the total number of various anatomical ablation locations reported will not total the overall number of subjects in a treatment group. | Number | Participants |
|
|
|
|
| Secondary | Percentage of Subjects Without Atrial Arrhythmia at 3 Months | Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter. | Intent-to-treat analysis population. | Posted | Number | Percentage of subjects | Baseline through 3 months |
|
|
|
|
| Secondary | Change in Mean C-Reactive Protein Level | Intent-to-treat analysis population. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 months |
|
|
|
|
| Secondary | Change in Mean Quality of Life Score | A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group. | Intent-to-treat analysis population. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months |
|
|
|
|
| Secondary | Change in Lipid Levels | The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated. | Intent-to-treat analysis population. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 months |
|
|
|
|
| 0 |
| 62 |
| 1 |
| 62 |
| EG001 | Placebo | Placebo (dummy) tablet taken once daily by mouth for 90 days | 0 | 63 | 1 | 63 |
| Puncture of the subclavian artery during ablation procedure | Surgical and medical procedures | Non-systematic Assessment | The puncture was repaired surgically. |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain resolved two days after stopping Lipitor. |
|
| Elevated liver function tests | Hepatobiliary disorders | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment | Headache resolved within 24 hours of stopping atorvastatin. |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Change in HDL (high-density lipoprotein) cholest. |
|
| t-test, 2 sided |
| <0.001 |
A p-value of < 0.05 was considered statistically significant. |
| 95 |
| No |
| Superiority or Other |
| The change in HDL cholesterol was compared between treatment groups. | t-test, 2 sided | 0.92 | A p-value of < 0.05 was considered statistically significant. | 95 | No | Superiority or Other |