The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism

NCT03185845 — Not applicable, Unknown, 392 participants, Chinese Academy of Medical Sciences, Fuwai Hospital

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The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism-- A National Multicenter, Prospective, Randomized, Controlled Clinical Trial

Registry	NCT03185845
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	392 (Estimated)
Sponsor	Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
Conditions	COPD Exacerbation, PTE - Pulmonary Thromboembolism
Interventions	Warfarin (Drug)
Dates	start 2017-06-15 (estimated), primary completion 2020-12-31 (estimated), completion 2020-12-31 (estimated), first posted 2017-06-14, last updated 2017-06-14
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Prolonged anticoagulation	Experimental	Drug: Warfarin	3 months longer anticoagulation after regular treatment
Regular anticoagulation	No intervention		stop anticoagulation after regular treatment

Warfarin (Drug): tailored dose according to international normalized ratio (INR) for 3 months

+Outcome measures

Primary outcomes

Venous thromboembolism recurrence [3 years]: recurrence rate in %

Secondary outcomes

Chronic obstructive pulmonary disease exacerbations [3 year]: total times

+Eligibility

Sex: All, ages: 40 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with major bleeding during prior anticoagulation
* Patients need long term anticoagulation to treat other diseases
* Patients unwilling to receive prolonged anticoagulation

+Locations (1)

Facility	City	Country	Status
Beijing Chaoyang Hospital	Beijing, Beijing Municipality	China	Recruiting

My Notes

Public

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