SPORTIF II (ximelagatran vs warfarin standard dose) Trial

SPORTIF II (ximelagatran vs warfarin standard dose) study, 2002	TRC2636
	download pdf: ximelagatran \| antithrombotics for atrial fibrillation

Treatments

Studied treatment	ximelegatran 20,40,60 mg twice daily
Control treatment	warfarin standard dose(target INR 2-3)
Concomittant treatment	Beta-blockers,angiotensin-converting enzyme inhibitors,calcium antagonists Low doses of aspirin are accepted(up to 160 mg/day)
Remarks	-treatment with either NSAI agents or fibrinolytic agents within the week before the start was prohibited -patient previously receiving warfarin were given ximelegatran once INR value was 1.5 or under/after the end of the study patients who stopped ximelegatran began warfarin 12 to 24 h after last intake.

Patients

Medium to high risk patients with chronic non valvular atrial fibrillation.

Inclusion criteria

-one or more stroke risk factor in addition to AF:history of hypertension,age >65,previous stroke or TIA,previous systemic embolism,left ventricular dysfunction,diabete mellitus,coronary heart disease -age>18 -paroxysmal or persistent NVAF verified by at least 2 ECG

Exclusion criteria

Stroke and /or systemic embolism within the previous 2 years,Condition associated with increased risk of bleeding,NVAF secondary to other reversible disorders,presence of mecanical heart valves,Myocardial infarction,coronary artery bypass grafting or Percutaneous transluminal coronary angioplasty within previous 3 month,Diagnosis of left ventricular aneurysm or atrial myxoma,Treatment with NSAIDs or fibrinolytics within previous week,Renal impairment,Blood pressure >180/100,History of rheumatic fever,Liver insufficiency,Hb<100g/l,Plat<100000,Contra-indication to warfarin treatment

Remarks

-SPORTIF II is a dose guiding study -66 patient received 20mg,62 received 40mg,59 received 60 mg

Baseline characteristics

age(mean)	70
male(%)	61
hypertension(%)	57
diabete mellitus(%)	21
left ventricular dysfunction(%)	31
subgroup test	d

Method and design

Randomized effectives	187 / 67 (studied vs. control)
Design	Parallel groups
Blinding	Open
Follow-up duration	16 weeks
Number of centre	37
Geographic area	Europe ,USA
Primary endpoint	Thrombo-embolic events and bleedings
Remarks	it is a dose guiding study

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

systemic thrombo-embolic complication

0 / 187
0 / 67
classic 0,36 [0,00;90,95]

stroke (fatal and non fatal)

1 / 187
0 / 67
classic 1,79 [0,02;130,07]

ischemic stroke

1 / 187
0 / 67
classic 1,79 [0,02;130,07]

All cause death

1 / 187
0 / 67
classic 1,79 [0,02;130,07]

Major bleeding

0 / 187
1 / 67
classic 0,07 [0,00;5,20]

Minor bleeding

16 / 187
6 / 67
classic 0,96 [0,39;2,34]

Haemmorhagic stroke

0 / 187
0 / 67
classic 0,36 [0,00;90,95]

Fatal stroke

0 / 187
0 / 67
classic 0,36 [0,00;90,95]

Adverse events

90 / 187
34 / 67
0,95 [0,72;1,25] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
systemic thrombo-embolic complication	0 / 187 (0,3%)	0 / 67 (0,7%)	0,36	[0,01;17,88]
stroke (fatal and non fatal)	1 / 187 (0,5%)	0 / 67 (0,7%)	0,72	[0,02;21,12]	assessed by computed tomography or magnetic resona
ischemic stroke	1 / 187 (0,5%)	0 / 67 (0,7%)	0,72	[0,02;21,12]
All cause death	1 / 187 (0,5%)	0 / 67 (0,7%)	0,72	[0,02;21,12]
Major bleeding	0 / 187 (0,3%)	1 / 67 (1,5%)	0,18	[0,01;5,28]	clinically overt bleeding and critical site bleeding(intracranial,retroperitoneal,intraocular,spinal,pericardial) and/or number of units transfused <2 or drop of Hb>2.0g/l and/or need for a medical or surgical intervention
Minor bleeding	16 / 187 (8,6%)	6 / 67 (9,0%)	0,96	[0,39;2,34]	clinically overt bleeding , no critical site bleeding, no drop of Hb >2g/l, no need for medical or surgical intervention
Haemmorhagic stroke	0 / 187 (0,3%)	0 / 67 (0,7%)	0,36	[0,01;17,88]
Fatal stroke	0 / 187 (0,3%)	0 / 67 (0,7%)	0,36	[0,01;17,88]
Adverse events	90 / 187 (48,1%)	34 / 67 (50,7%)	0,95	[0,72;1,25]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 16 weeks)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Minor bleeding	8,56%	8,96%	-0,40%
Adverse events	48,13%	50,75%	-2,62%

Meta-analysis of all similar trials:

antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

direct antithrombins in atrial fibrillation for all type of patients

new oral anticoagulants in atrial fibrillation for all type of patients

Reference(s)

TrialResults-center ID	TRC2636
Trials register #	NA