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The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery |
|
| Control | Placebo Comparator | Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Incidence After Open Cardiac Valve Repair | Within 5 days after open cardiac valve repair |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yousef Rezaei, M.D | Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seyyed-al-Shohada Heart Center | Urmia | West Azerbaijan Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25540059 | Derived | Dehghani MR, Kasianzadeh M, Rezaei Y, Sepehrvand N. Atorvastatin Reduces the Incidence of Postoperative Atrial Fibrillation in Statin-Naive Patients Undergoing Isolated Heart Valve Surgery: A Double-Blind, Placebo-Controlled Randomized Trial. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):465-72. doi: 10.1177/1074248414564869. Epub 2014 Dec 24. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery |
| FG001 | Control | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled patients completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery |
| BG001 | Control | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Atrial Fibrillation Incidence After Open Cardiac Valve Repair | Posted | Number | participants | Within 5 days after open cardiac valve repair |
|
|
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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 | Treatment | Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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The sample size of this study was small
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yousef Rezaei | Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences | +989126231864 | yousefrezaei1986@gmail.com |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 1 |
| 29 |
| 0 |
| 29 |
| EG001 | Control | Placebo | 2 | 29 | 0 | 29 |
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |