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

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

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.

Study Overview

• Status: Unknown
• Conditions: COPD Exacerbation; PTE - Pulmonary Thromboembolism
• Intervention / Treatment: Drug: Warfarin

• Study Type: Interventional
• Enrollment (Anticipated): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100043
      • Recruiting
      • Beijing Chaoyang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prolonged anticoagulation; 3 months longer anticoagulation after regular treatment	Drug: Warfarin; tailored dose according to international normalized ratio (INR) for 3 months
NO_INTERVENTION: Regular anticoagulation; stop anticoagulation after regular treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous thromboembolism recurrence	recurrence rate in %	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic obstructive pulmonary disease exacerbations	total times	3 year

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 15, 2017
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Thromboembolism; Pulmonary Embolism; Anticoagulants; Warfarin
• Other Study ID Numbers: 2016YFC1304402B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No