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

NCT02979561 | Unknown Phase 4

• 1 other identifier: RE-SPIRE study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• recurrent PE

  according to Echocardiogram, scintigraphy of the lungs

  6 month

• death

  6 month

Secondary Outcomes (4)

• hemorrhagic complications

  6 month

• postembolic residual pulmonary hypertension

  6 month

• recurrent deep vein thrombosis

  3 month

• recurrent deep vein thrombosis

  6 month

Study Arms (2)

group of dabigatran

EXPERIMENTAL

Drug: Dabigatran Etexilate

group of warfarin

ACTIVE COMPARATOR

Drug: Warfarin

Interventions

Dabigatran Etexilate 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 dabigatran

Warfarin 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.

group of warfarin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

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

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Dabigatran; Warfarin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Central Study Contacts

Andrey Karpenko, MD\PhD

CONTACT

a_karpenko@meshalkin.ru

Alexey Cheban, MD

CONTACT

cheban_a@meshalkin.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 1, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 20, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)