NCT02084069

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 4, 2015

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

March 8, 2014

Results QC Date

January 21, 2015

Last Update Submit

February 13, 2015

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation Incidence After Open Cardiac Valve Repair

    Within 5 days after open cardiac valve repair

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery

Drug: Atorvastatin

Control

PLACEBO COMPARATOR

Placebo

Interventions

AtorvastatinDRUG
Treatment

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 25 y/o
  • No occurrence of intra- or post-operative cardiopulmonary arrest
  • Not consuming drugs affecting atrial rhythm
  • Having sinus rhythm before surgery
  • Lack of paroxysmal atrial fibrillation history
  • Only undergo heart valve surgery
  • Lack of considerable heart ischemia needed atorvastatin use
  • Routine cares in ward, post-operative ward, and intensive care unit were done

You may not qualify if:

  • Lesser than 25 y/o
  • History of atrial fibrillation
  • History of taking anti-arrhythmic drugs
  • History of implementing pacemakers
  • Severe heart failure
  • Renal failure
  • Hepatic failure
  • Severe pulmonary diseases
  • Heart block or bradyarrhythmia
  • Routine cares in ward, post-operative ward, and intensive care unit were not done
  • Performing concomitant cardiac surgery except valve repair
  • Having considerable heart ischemia needed atorvastatin use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyyed-al-Shohada Heart Center

Urmia, West Azerbaijan Province, Iran

Location

Related Publications (1)

  • 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.

    PMID: 25540059DERIVED

Related Links

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Limitations and Caveats

The sample size of this study was small

Results Point of Contact

Title
Yousef Rezaei
Organization
Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences
yousefrezaei1986@gmail.com
+989126231864

Study Officials

  • Yousef Rezaei, M.D

    Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2014

First Posted

March 11, 2014

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 4, 2015

Results First Posted

February 4, 2015

Record last verified: 2015-02

Locations

IR(1)