Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism undergoIng Endovascular Mechanical Fragmentation and Thrombolytic Therapy

Phase 4

• Conditions: Angiographically Confirmed Acute Massive Pulmonary Embolism Treated With Endovascular Mechanical Fragmentation and Thrombolytic Therapy
• Interventions: Drug: Dabigatran Etexilate; Drug: Warfarin

• Registration Number: NCT02979561
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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. \[RE-SPIRE study\]

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Status Verified: 2016-11
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-01
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Men and women aged > 18 years
• Angiographically confirmed acute massive pulmonary embolism with involvement of Central pulmonary arteries.
• endovascular mechanical thrombus fragmentation + thrombolytic therapy (using recombinant tissue activator of plasminogen), performed for treatment of the above-mentioned pulmonary embolism in less than 48 hours before randomization. The patient should be randomized no earlier than 24 hours after procedures endovascular mechanical thrombus fragmentation + thrombolytic therapy
• Written informed consent signed by patient.

Exclusion Criteria

• Signs of hemodynamic instability (i.e. systolic blood pressure <100 mm Hg.St. or episode of systolic blood pressure fall for ≥40 mm Hg. / or heart rate > 110 lasting more than 15 min) or need for ventilatory support within 12 hours prior to randomisation.
• The indication for oral anticoagulation, associated with others disease.
• malignant neoplasm of any location
• Contraindications to warfarin or pradaxa according to Russian Instructions for medical use of these drugs
• Indications for concomitant treatment with antiplatelet agents
• Any stroke within 6 months before randomization
• Intracranial hemorrhage in anamnesis
• Active bleeding, bleeding diathesis.
• Clinically significant bleeding within the last 30 days.
• Trauma or extensive surgery within 1 month before randomization or surgery planned in the next 6 months after randomization.
• Intracranial pathology: tumor, arteriovenous fistula or aneurysm.
• Gastrointestinal bleeding in the previous 3 months.
• Gastric ulcer or duodenal ulcer with clinical manifestations or endoscopically identified acute ulcer without signs of scarring during previous 30 days.
• Uncontrolled hypertension (systolic blood pressure> 180 mm Hg. and / or diastolic blood pressure> 100 mm.hg in patients receiving antihypertensive drugs).
• Pregnancy, lactation.
• Life expectancy <6 months.
• Clinically significant liver disease.
• Creatinine clearance (estimated by Cockcroft-Gault) <30 ml / min.
• hemoglobin level <90 g/l), thrombocytopenia <100x10^9 / L.
• Patients who, in the opinion of the researcher, are not suitable for inclusion in the study, for example, due to the low likelihood of doctor's recommendations following.
• Long-term use of NSAIDs
• Current participation in another clinical study.
• Allergic to contrast substance or radioisotope drugs used in procedures to assess endpoints of the study, which according to researchers, may be a contraindication to the implementation of these research methods.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group of dabigatran	Dabigatran Etexilate	-
group of warfarin	Warfarin	-

Primary Outcome Measures

Name	Time	Method
recurrent PE	6 month	according to Echocardiogram, scintigraphy of the lungs
death	6 month

Secondary Outcome Measures

Name	Time	Method
recurrent deep vein thrombosis	6 month	according to ultrasound of the deep veins
hemorrhagic complications	6 month	according to the ISTH criteria
postembolic residual pulmonary hypertension	6 month	according to scintigraphy of the lungs

Trial Locations

Locations (1)

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology; 🇷🇺 Novosibirsk, Russian Federation