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

NCT ID: NCT02979561

Last Updated: 2016-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-06-30

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]

Conditions

Angiographically Confirmed Acute Massive Pulmonary Embolism Treated With Endovascular Mechanical Fragmentation and Thrombolytic Therapy

Keywords

Dabigatran etexilate; Recurrence of DVT; Pulmonary Embolism; Warfarin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group of dabigatran

Group Type: EXPERIMENTAL

Dabigatran Etexilate

Intervention Type: DRUG

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.

group of warfarin

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology

Novosibirsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Andrey Karpenko, MD\PhD

Role: CONTACT

Email: a_karpenko@meshalkin.ru

Alexey Cheban, MD

Role: CONTACT

Email: cheban_a@meshalkin.ru

Facility Contacts

Alexey Cheban, MD

Role: primary

Other Identifiers

RE-SPIRE study

Identifier Type: -

Identifier Source: org_study_id