A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa or warfarin for prevention of recurrent DVT in patients with angiographically confirmed acute massive pulmonary embolism undergoIng endovascular mechanical fragmentation and thrombolytic therapy. \[RE-SPIRE study\]
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
All patients in this group continue to receive unfractionated heparin for 5-7 days, and then transferred to the drug Pradaxa dose of 150 mg 2 times a day. Pradaxa administration continued until the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.
all patients continue to receive unfractionated heparin intravenously and at the same time (from the date of randomization) start warfarin, accompanied by regular measurement of the INR every day or every other day. As soon as INR reaches the range of 2.0 to 3.0, the administration of the unfractionated heparin should be discontinued. Further measurements of INR should be performed once a month during outpatient visits. The patient continues to receive warfarin under the control of the INR till the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Novosibirsk, Russia
RECRUITINGrecurrent PE
according to Echocardiogram, scintigraphy of the lungs
Time frame: 6 month
death
Time frame: 6 month
hemorrhagic complications
according to the ISTH criteria
Time frame: 6 month
postembolic residual pulmonary hypertension
according to scintigraphy of the lungs
Time frame: 6 month
recurrent deep vein thrombosis
according to ultrasound of the deep veins
Time frame: 3 month
recurrent deep vein thrombosis
according to ultrasound of the deep veins
Time frame: 6 month
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