The Appropriate Anticoagulation Duration for Chronic Obst... | NCT03185845

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

NCT03185845

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Jun 14, 2017Actual

Enrollment

392Estimated

Phase

Not Applicable

Conditions

COPD Exacerbation
PTE - Pulmonary Thromboembolism

Interventions

Warfarin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jun 12, 2017

First Submission Date that Met QC Criteria

Jun 12, 2017

First Posted Date

Jun 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2017

Last Update Posted Date

Jun 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

392Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prolonged anticoagulation	Experimental	3 months longer anticoagulation after regular treatment	Drug: Warfarin
Regular anticoagulation	No Intervention	stop anticoagulation after regular treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Warfarin	Drug	tailored dose according to international normalized ratio (INR) for 3 months	Prolonged anticoagulation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuanhua Yang, MD	Contact	13911773607		yyh1031@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Chaoyang Hospital	Recruiting	Beijing	Beijing Municipality	100043	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014859	Warfarin

Ancestor Terms

ID	Term
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573

Browse Leaves

Not provided

Browse Branches

Not provided