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

NCT ID: NCT03185845

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation PTE - Pulmonary Thromboembolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prolonged anticoagulation

3 months longer anticoagulation after regular treatment

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

tailored dose according to international normalized ratio (INR) for 3 months

Regular anticoagulation

stop anticoagulation after regular treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Warfarin

tailored dose according to international normalized ratio (INR) for 3 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianguo He

Chief of Pulmonary Vascular Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuanhua Yang, MD

Role: CONTACT

13911773607

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuanhua Yang, MD

Role: primary

13911773607

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016YFC1304402B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chemoprophylaxis Plus Early Ambulation
NCT03862755 COMPLETED PHASE4
Diclofenac for Submassive PE
NCT01590342 TERMINATED PHASE2/PHASE3