Long-term Safety in Atrial Fibrillation Patients | NCT00645853

Long-term Safety in Atrial Fibrillation Patients | NCT00645853 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: AZD0837
2	Active Comparator		Drug: VKA INR 2-3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD0837	Drug	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od	1

Outcomes Module

Measure	Description	Time Frame
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period	Participants	154-711 days on treatment

Secondary Outcomes

Measure	Description	Time Frame
Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline	ULN=Upper limit of Normal	From baseline to Follow up
Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline

Contacts/Locations Module

Name	Affiliation	Role
Lars Hvilstedt Rasmussen, MD, PhD, FESC	Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark	Principal Investigator

Arm/Group Information

ID	Title	Description
FG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
FG001	VKA, INR 2-3	Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000288 subjects FG001235 subjects
No of Patients After Dose Switch		FG000209 subjectsAll patients in the AZD0837 arm switched from their initial doses, to a general dose of 300 mg od FG001188 subjectsNo changes for VKA patients
Discontinued Patient No Due to Closure		FG000196 subjectsNo of patients discontinued due the study termination caused tablet formulation stability problems FG001178 subjectsNo of patients discontinued due the study termination caused tablet formulation stability problems
AZ Study Closure in Hungary		FG00060 subjects FG00140 subjects
COMPLETED		FG000196 subjects FG001178 subjects
NOT COMPLETED		FG00092 subjects FG00157 subjects

Type	Comment	Reasons
Adverse Event		FG00018 subjects FG0017 subjects
AZ study closure in Hungary		FG00060 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
BG001	VKA, INR 2-3

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period

Participants

Posted

Number

Participants

154-711 days on treatment

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
OG001	VKA, INR 2-3	Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Gerard Lynch	AstraZeneca			aztrial_results_posting@astrazeneca.com

Intervention Browse Module

ID	Term
C551586	AZD 0837
D014859	Warfarin

ID	Term
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573

Secondary

Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline

ULN=Upper limit of Normal

Posted

Number

Participants

From baseline to Follow up

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
OG001	VKA, INR 2-3	Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Units	Counts
Participants	OG000288 OG001235

Title

Denominators

Categories

Title	Measurements
	OG0009 OG0016

Secondary

Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline

Posted

Number

Participants

From baseline to Follow up

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
OG001	VKA, INR 2-3	Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Units	Counts
Participants	OG000288 OG001235

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0013

Secondary

Creatinine: Absolute Change From Baseline, at End of Treatment

Posted

Mean

Full Range

µmol/L

Baseline and End of treatment

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
OG001	VKA, INR 2-3	Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Units	Counts
Participants	OG000288 OG001235

Title

Denominators

Categories

Title	Measurements
	OG0003.70± -67.0(-67.0 to 120.0) OG001-1.17± -56.0(-56.0 to 116)

Secondary

D-dimer:Median and Quartile Range at End of Treatment

Median (Lower Quartile-Upper Quartile ), ng/mL

Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis

Posted

Median

Inter-Quartile Range

ng/mL

End of treatment

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
OG001	VKA, INR 2-3	Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5

Units	Counts
Participants	OG000193 OG001232

Title

Denominators

Categories

Title	Measurements
	OG00068.9(43.3 to 128.4) OG00154.9(31.9 to 99.0)

Secondary

Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment

Median Full range, Seconds

Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis

Posted

Median

Full Range

sec

Baseline and End of treatment

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.

Units	Counts
Participants	OG000173

Title

Denominators

Categories

Title	Measurements
	OG00012.9(-62 to 43)

Secondary

Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment

Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis

Posted

Median

Full Range

sec

Baseline and End of Treatment

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.

Units	Counts
Participants	OG000129

Title

Denominators

Categories

Title	Measurements
	OG00049.0(-5 to 96)

Secondary

AZD0837: Plasma Concentration of AZD0837 at End of Treatment

Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis

Posted

Median

Full Range

nmol/L

End of treatment

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.

Units	Counts
Participants	OG000195

Title

Denominators

Categories

Title	Measurements
	OG000675(10 to 4090)

Secondary

AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment

Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis

Posted

Median

Full Range

nmol/L

154-711 days on treatment

ID	Title	Description
OG000	AZD0837	Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.

Units	Counts
Participants	OG000195

Title

Denominators

Categories

Title	Measurements
	OG000341(10 to 929)