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

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ClinicalTrials.gov Identifier: NCT02979561
Recruitment Status : Unknown
Verified November 2016 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : December 1, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
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]

Condition or disease Intervention/treatment Phase
Angiographically Confirmed Acute Massive Pulmonary Embolism Treated With Endovascular Mechanical Fragmentation and Thrombolytic Therapy Drug: Dabigatran Etexilate Drug: Warfarin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Study to Evaluate Outcomes of the Treatment With Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism Undergoing Endovascular Mechanical Fragmentation and Thrombolytic Therapy
Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: group of dabigatran Drug: Dabigatran Etexilate
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.

Active Comparator: group of warfarin Drug: Warfarin
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.




Primary Outcome Measures :
  1. recurrent PE [ Time Frame: 6 month ]
    according to Echocardiogram, scintigraphy of the lungs

  2. death [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. hemorrhagic complications [ Time Frame: 6 month ]
    according to the ISTH criteria

  2. postembolic residual pulmonary hypertension [ Time Frame: 6 month ]
    according to scintigraphy of the lungs

  3. recurrent deep vein thrombosis [ Time Frame: 3 month ]
    according to ultrasound of the deep veins

  4. recurrent deep vein thrombosis [ Time Frame: 6 month ]
    according to ultrasound of the deep veins



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979561


Contacts
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Contact: Andrey Karpenko, MD\PhD a_karpenko@meshalkin.ru
Contact: Alexey Cheban, MD cheban_a@meshalkin.ru

Locations
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Russian Federation
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Alexey Cheban, MD       cheban_a@meshalkin.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02979561     History of Changes
Other Study ID Numbers: RE-SPIRE study
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Dabigatran etexilate
Recurrence of DVT
Pulmonary Embolism
Warfarin

Additional relevant MeSH terms:
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Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Dabigatran
Fibrinolytic Agents
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrin Modulating Agents