The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism
1 other identifier
interventional
392
1 country
1
Brief Summary
Anticoagulation is the most important treatment for pulmonary thromboembolism (PTE). The thromboembolism risk is especially high in patients with chronic obstructive pulmonary disease (COPD) exacerbations. However, there's no agreement on the most appropriate duration of anticoagulation in COPD with PTE to balance the risk of recurrence of thrombosis and bleeding. This randomized, controlled trial aims to evaluate the risk and benefit of prolonged anticoagulation compared with the regular 3-month anticoagulation in COPD with PTE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 14, 2017
June 1, 2017
3.5 years
June 12, 2017
June 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Venous thromboembolism recurrence
recurrence rate in %
3 years
Secondary Outcomes (1)
Chronic obstructive pulmonary disease exacerbations
3 year
Study Arms (2)
Prolonged anticoagulation
EXPERIMENTAL3 months longer anticoagulation after regular treatment
Regular anticoagulation
NO INTERVENTIONstop anticoagulation after regular treatment
Interventions
tailored dose according to international normalized ratio (INR) for 3 months
Eligibility Criteria
You may qualify if:
- Hospitalized patients due to chronic obstructive pulmonary disease exacerbation and diagnosed as newly developed pulmonary thromboembolism
- Regular anticoagulation for 3 months and got CT pulmonary angiography
You may not qualify if:
- Patients with major bleeding during prior anticoagulation
- Patients need long term anticoagulation to treat other diseases
- Patients unwilling to receive prolonged anticoagulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100043, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Pulmonary Vascular Disease Center
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 14, 2017
Study Start
June 15, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 14, 2017
Record last verified: 2017-06