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

Overview

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.

Full Title of Study: “The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism—— A National Multicenter, Prospective, Randomized, Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Prolonged anticoagulation
    • 3 months longer anticoagulation after regular treatment
  • No Intervention: Regular anticoagulation
    • stop anticoagulation after regular treatment

Clinical Trial Outcome Measures

Primary Measures

  • Venous thromboembolism recurrence
    • Time Frame: 3 years
    • recurrence rate in %

Secondary Measures

  • Chronic obstructive pulmonary disease exacerbations
    • Time Frame: 3 year
    • total times

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jianguo He, Chief of Pulmonary Vascular Disease Center – Chinese Academy of Medical Sciences, Fuwai Hospital
  • Overall Contact(s)
    • Yuanhua Yang, MD, 13911773607, yyh1031@sina.com

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