Protocol summary

Summary
A total of 100 patients with AF who underwent catheter ablation were randomized to treatment with dabigatran (D) 110 mg twice daily or warfarin (W) adjusted to an international normalized ratio (INR) of 2.0 to 3.0 for 3 months after ablation procedure. C - reactive protein (CRP), D-dimer, prothrombin fragment F1+2 (F1+2), were measured at baseline before ablation procedures, after 30 days and after 90 days of treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122311855N1
Registration date: 2013-01-18, 1391/10/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-01-18, 1391/10/29
Registrant information
Name
Shahideh Amini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2139
Email address
sh_amini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized comparison between dabigatran and warfarin on coagulation activity and inflammatory markers in patients with atrial fibrillation
Public title
ِDabigatran versus warfarin in atrial fibrillation patients post catheter ablation
Purpose
Prevention
Inclusion/Exclusion criteria
drug-refractory, symptomatic AF who had indications for ablation included in this study. Patients were excluded in the presence of a severe heart-valve disorder, stroke within 14 days or severe stroke within 6 months before screening, a condition that increased the risk of hemorrhage, a creatinine clearance of less than 30 ml per minute, an active liver disease, and pregnancy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Univercity of medical sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2011-06-13, 1390/03/23
Ethics committee reference number
8933

Health conditions studied

1

Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
CRP
Timepoint
baseline, first month, third month
Method of measurement
serum samples

2

Description
D-Dimer
Timepoint
baseline, first month, third month
Method of measurement
serum samples

3

Description
prothrombin fragment F1+2
Timepoint
baseline, first month, third month
Method of measurement
serum samples

Secondary outcomes

1

Description
bleeding
Timepoint
baseline, first month, third month
Method of measurement
CBC test

Intervention groups

1

Description
dabigatran (D) 110 mg twice daily (intervention group)
Category
Treatment - Drugs

2

Description
warfarin (W) adjusted to an international normalized ratio (INR) of 2.0 to 3.0 (control group)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center, Tehran University of Medical Sciences
Full name of responsible person
Bahram Fariborz Farsad
Street address
Niayesh_Valiasr Crossroads
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
shahideh amini
Street address
Tehran University of Medical Science
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahideh Amini
Position
Pharm D
Other areas of specialty/work
Street address
Pharmacy School, TUMS
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
sh_amini@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Bahram Fariborz Farsad
Position
Pharm D
Other areas of specialty/work
Street address
Niayesh-Valiasr Crossroad
City
Tehran
Postal code
Phone
+98 21 2392 2139
Fax
Email
ffarsad@yaoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Hooman Bakhshandeh
Position
MD, PhD
Other areas of specialty/work
Street address
Niayesh-Valiasr Crossraods
City
Tehran
Postal code
Phone
+98 21 2392 3138
Fax
Email
hooman.bakhshande@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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