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NCT03185845 Clinical Trial

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

COPD Exacerbation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03185845
Other study ID # 2016YFC1304402B
Secondary ID
Status Recruiting
Phase N/A
First received June 12, 2017
Last updated June 12, 2017
Start date June 15, 2017
Est. completion date December 31, 2020

Study information
Verified date June 2017
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Yuanhua Yang, MD
Phone 13911773607
Email yyh1031@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 392
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Beijing Chaoyang Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Venous thromboembolism recurrence recurrence rate in % 3 years
Secondary Chronic obstructive pulmonary disease exacerbations total times 3 year
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