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

Primary Purpose

COPD Exacerbation, PTE - Pulmonary Thromboembolism

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Warfarin
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Chaoyang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prolonged anticoagulation

Regular anticoagulation

Arm Description

3 months longer anticoagulation after regular treatment

stop anticoagulation after regular treatment

Outcomes

Primary Outcome Measures

Venous thromboembolism recurrence
recurrence rate in %

Secondary Outcome Measures

Chronic obstructive pulmonary disease exacerbations
total times

Full Information

First Posted
June 12, 2017
Last Updated
June 12, 2017
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03185845
Brief Title
The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism
Official Title
The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism-- A National Multicenter, Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation, PTE - Pulmonary Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
392 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prolonged anticoagulation
Arm Type
Experimental
Arm Description
3 months longer anticoagulation after regular treatment
Arm Title
Regular anticoagulation
Arm Type
No Intervention
Arm Description
stop anticoagulation after regular treatment
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
tailored dose according to international normalized ratio (INR) for 3 months
Primary Outcome Measure Information:
Title
Venous thromboembolism recurrence
Description
recurrence rate in %
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Chronic obstructive pulmonary disease exacerbations
Description
total times
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanhua Yang, MD
Phone
13911773607
Email
yyh1031@sina.com
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100043
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanhua Yang, MD
Phone
13911773607
Email
yyh1031@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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