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See also:
All pulmonary embolism clinical trials
All venous thrombosis clinical trials
All clinical trials of direct oral anticoagulant (DAO)
All clinical trials of apixaban (without LMWH)
|
|
Treatments
Studied treatment |
apixaban 10 mg twice daily for 7 days then 5 mg, twice daily, 6 months
|
Control treatment |
conventional
therapy: enoxaparin 1mg/kg twice daily until INR>=2 then warfarin for an INR between 2-4, once daikly, 6 months
|
Patients
Patients |
patients with deep vein thrombosis or pulmonary embolism |
Exclusion criteria |
contraindications for enoxaparin or warfarin; active bleeding or high risk for serious bleeding; short life expectancy; uncontrolled high blood pressure; significantly impaired kidney or liver function
|
Method and design
Randomized effectives |
2691 / 2704 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
6 mo |
Primary endpoint |
Venous thromboembolic recurrence or death |
Results
Endpoints and data reported in the trial's publication(s)
Endpoint |
Events (%) |
Relative Risk |
95% CI |
|
Studied treat. |
Control treat. |
First recurrent VTE or VTE-related death � no. (%) |
59 / 2609 (2,3%) |
71 / 2635 (2,7%) |
0,84 |
[0,60;1,18] |
|
Fatal PE |
1 / 2609 (0,0%) |
2 / 2635 (0,1%) |
0,50 |
[0,05;5,57] |
|
Death for which PE could not be ruled out |
11 / 2609 (0,4%) |
13 / 2635 (0,5%) |
0,85 |
[0,38;1,90] |
|
Nonfatal PE with or without DVT |
27 / 2609 (1,0%) |
23 / 2635 (0,9%) |
1,19 |
[0,68;2,06] |
|
DVT only |
20 / 2609 (0,8%) |
33 / 2635 (1,3%) |
0,61 |
[0,35;1,06] |
|
Major bleeding � no. (%)� |
15 / 2676 (0,6%) |
49 / 2689 (1,8%) |
0,31 |
[0,17;0,55] |
|
Fatal bleeding� |
1 / 2676 (0,0%) |
2 / 2689 (0,1%) |
0,50 |
[0,05;5,54] |
|
Nonfatal major bleeding at a critical site |
4 / 2676 (0,1%) |
14 / 2689 (0,5%) |
0,29 |
[0,09;0,87] |
|
Intracranial Nonfatal major bleeding |
3 / 2676 (0,1%) |
6 / 2689 (0,2%) |
0,50 |
[0,13;2,01] |
|
Retroperitoneal Nonfatal major bleeding |
1 / 2676 (0,0%) |
3 / 2689 (0,1%) |
0,33 |
[0,03;3,22] |
|
Intrathoracic Nonfatal major bleeding |
0 / 2676 (0,0%) |
1 / 2689 (0,0%) |
0,50 |
[0,02;14,97] |
|
Intraocular Nonfatal major bleeding |
0 / 2676 (0,0%) |
2 / 2689 (0,1%) |
0,25 |
[0,01;5,57] |
|
Intraarticular Nonfatal major bleeding |
0 / 2676 (0,0%) |
2 / 2689 (0,1%) |
0,25 |
[0,01;5,57] |
|
Other nonfatal major bleeding |
10 / 2676 (0,4%) |
33 / 2689 (1,2%) |
0,30 |
[0,15;0,62] |
|
Gastrointestinal Nonfatal major bleeding |
7 / 2676 (0,3%) |
18 / 2689 (0,7%) |
0,39 |
[0,16;0,93] |
|
Intramuscular Nonfatal major bleeding |
0 / 2676 (0,0%) |
5 / 2689 (0,2%) |
0,10 |
[0,01;1,84] |
|
Epistaxis non fatal |
1 / 2676 (0,0%) |
1 / 2689 (0,0%) |
1,00 |
[0,06;16,06] |
|
Urogenital Nonfatal major bleeding |
1 / 2676 (0,0%) |
3 / 2689 (0,1%) |
0,33 |
[0,03;3,22] |
|
non fatal Subcutaneous hematoma |
1 / 2676 (0,0%) |
6 / 2689 (0,2%) |
0,17 |
[0,02;1,39] |
|
all cause death |
41 / 2676 (1,5%) |
52 / 2689 (1,9%) |
0,79 |
[0,53;1,19] |
|
|
41 / 2676 (1,5%) |
52 / 2689 (1,9%) |
0,79 |
[0,53;1,19] |
|
death PE or PE not ruled out |
12 / 2676 (0,4%) |
16 / 2689 (0,6%) |
0,75 |
[0,36;1,59] |
|
death Cardiovascular cause |
3 / 2676 (0,1%) |
7 / 2689 (0,3%) |
0,43 |
[0,11;1,66] |
|
death Bleeding |
2 / 2676 (0,1%) |
3 / 2689 (0,1%) |
0,67 |
[0,11;4,01] |
|
death Cancer |
14 / 2676 (0,5%) |
14 / 2689 (0,5%) |
1,00 |
[0,48;2,10] |
|
death Infectious disease |
9 / 2676 (0,3%) |
7 / 2689 (0,3%) |
1,29 |
[0,48;3,46] |
|
death Other |
1 / 2676 (0,0%) |
5 / 2689 (0,2%) |
0,20 |
[0,02;1,72] |
|
VTE or death from cardiovascular cause |
61 / 2609 (2,3%) |
77 / 2635 (2,9%) |
0,80 |
[0,57;1,11] |
|
VTE or death from any cause |
84 / 2609 (3,2%) |
104 / 2635 (3,9%) |
0,82 |
[0,62;1,08] |
|
VTE, VTE-related death, or major bleeding |
73 / 2609 (2,8%) |
118 / 2635 (4,5%) |
0,62 |
[0,47;0,83] |
|
Any Adverse events during treatment |
1795 / 2676 (67,1%) |
1923 / 2689 (71,5%) |
0,94 |
[0,91;0,97] |
|
Any serious adverse event during treatment |
417 / 2676 (15,6%) |
410 / 2689 (15,2%) |
1,02 |
[0,90;1,16] |
|
Any bleeding event |
415 / 2676 (15,5%) |
695 / 2689 (25,8%) |
0,60 |
[0,54;0,67] |
|
Any adverse event resulting in permanent discontinuation of study drug |
162 / 2676 (6,1%) |
199 / 2689 (7,4%) |
0,82 |
[0,67;1,00] |
|
Clinically relevant nonmajor bleeding |
103 / 2676 (3,8%) |
215 / 2689 (8,0%) |
0,48 |
[0,38;0,61] |
|
Major bleeding or clinically relevant nonmajor bleeding |
115 / 2676 (4,3%) |
261 / 2689 (9,7%) |
0,44 |
[0,36;0,55] |
|
Endpoints used by the meta-analysis and data retained for this trial
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Major bleeding
15 / 2676
49 / 2689
0,31 [0,17;0,55]
Symptomatic deep-vein thrombosis
20 / 2609
33 / 2635
0,61 [0,35;1,06]
Death related to venous thromboembolism
11 / 2609
13 / 2635
0,85 [0,38;1,90]
fatal pulmonary embolism
1 / 2609
2 / 2635
classic
0,50 [0,05;5,57]
VTE
59 / 2609
71 / 2635
0,84 [0,60;1,18]
recurrent VTE during treatment
59 / 2609
71 / 2635
0,84 [0,60;1,18]
symptomatic pulmonary embolism
27 / 2609
23 / 2635
classic
1,19 [0,68;2,06]
All cause death
41 / 2676
52 / 2689
0,79 [0,53;1,19]
non-fatal pulmonary embolism
27 / 2609
23 / 2635
classic
1,19 [0,68;2,06]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Major bleeding
|
15 / 2676 (0,6%) |
49 / 2689 (1,8%) |
0,31 |
[0,17;0,55] |
Major bleeding � no. (%)� |
|
recurrent VTE during treatment
|
59 / 2609 (2,3%) |
71 / 2635 (2,7%) |
0,84 |
[0,60;1,18] |
First recurrent VTE or VTE-related death � no. (%) |
|
symptomatic pulmonary embolism
|
27 / 2609 (1,0%) |
23 / 2635 (0,9%) |
1,19 |
[0,68;2,06] |
Nonfatal PE with or without DVT |
|
All cause death
|
41 / 2676 (1,5%) |
52 / 2689 (1,9%) |
0,79 |
[0,53;1,19] |
all cause death |
|
non-fatal pulmonary embolism
|
27 / 2609 (1,0%) |
23 / 2635 (0,9%) |
1,19 |
[0,68;2,06] |
Nonfatal PE with or without DVT |
|
VTE
|
59 / 2609 (2,3%) |
71 / 2635 (2,7%) |
0,84 |
[0,60;1,18] |
First recurrent VTE or VTE-related death � no. (%) |
|
Symptomatic deep-vein thrombosis
|
20 / 2609 (0,8%) |
33 / 2635 (1,3%) |
0,61 |
[0,35;1,06] |
DVT only |
|
Death related to venous thromboembolism
|
11 / 2609 (0,4%) |
13 / 2635 (0,5%) |
0,85 |
[0,38;1,90] |
Death for which PE could not be ruled out |
|
fatal pulmonary embolism
|
1 / 2609 (0,0%) |
2 / 2635 (0,1%) |
0,50 |
[0,05;5,57] |
Fatal PE |
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 6 mo)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Major bleeding |
5,61‰ |
1,82% |
-1,26%
|
recurrent VTE during treatment |
2,26% |
2,69% |
-0,43%
|
symptomatic pulmonary embolism |
1,03% |
8,73‰ |
0,16%
|
All cause death |
1,53% |
1,93% |
-0,40%
|
non-fatal pulmonary embolism |
1,03% |
8,73‰ |
0,16%
|
VTE |
2,26% |
2,69% |
-0,43%
|
Symptomatic deep-vein thrombosis |
7,67‰ |
1,25% |
-0,49%
|
Death related to venous thromboembolism |
4,22‰ |
4,93‰ |
-0,07%
|
fatal pulmonary embolism |
0,38‰ |
0,76‰ |
-0,04%
|
Meta-analysis of all similar trials:
antithrombotics in pulmonary embolism for all type of patients
antithrombotics in venous thrombosis for all type of patients
direct oral anticoagulant (DAO) in venous thrombosis for all types of patients
Reference(s)
TrialResults-center ID |
TRC10328
|
Trials register # |
NCT00643201
|
-
Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI.
Oral apixaban for the treatment of acute venous thromboembolism..
N Engl J Med 2013 Aug 29;369:799-808
- 10.1056/NEJMoa1302507
Pubmed
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Hubmed
| Fulltext
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