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Trial record 57 of 291 for:    warfarin AND anticoagulation

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

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ClinicalTrials.gov Identifier: NCT03185845
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation PTE - Pulmonary Thromboembolism Drug: Warfarin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism—— A National Multicenter, Prospective, Randomized, Controlled Clinical Trial
Estimated Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Venous thromboembolism recurrence [ Time Frame: 3 years ]
    recurrence rate in %


Secondary Outcome Measures :
  1. Chronic obstructive pulmonary disease exacerbations [ Time Frame: 3 year ]
    total times



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185845


Contacts
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Contact: Yuanhua Yang, MD 13911773607 yyh1031@sina.com

Locations
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China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100043
Contact: Yuanhua Yang, MD    13911773607    yyh1031@sina.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital

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Responsible Party: Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03185845     History of Changes
Other Study ID Numbers: 2016YFC1304402B
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warfarin
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Embolism
Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Embolism
Anticoagulants