COPD ExacerbationNCT03185845
The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism
A study testing Warfarin in people with COPD Exacerbation and PTE - Pulmonary Thromboembolism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation, PTE - Pulmonary Thromboembolism
- What is being tested?
- Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with major bleeding during prior anticoagulation
- Patients need long term anticoagulation to treat other diseases
- Patients unwilling to receive prolonged anticoagulation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100043
Yuanhua Yang, MD, 13911773607, yyh1031@sina.com
About this study
Official title: 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.
- Conditions
- COPD Exacerbation, PTE - Pulmonary Thromboembolism
- Being tested
- Warfarin
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
tailored dose according to international normalized ratio (INR) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Prolonged anticoagulation | Experimental | 3 months longer anticoagulation after regular treatment Receives: Drug: Warfarin |
| Regular anticoagulation | No intervention | stop anticoagulation after regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism recurrence
recurrence rate in %
Measured: 3 years
Secondary outcomes (1)
Chronic obstructive pulmonary disease exacerbations
total times
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185845
- Sponsor's protocol ID
- 2016YFC1304402B
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism-- A National Multicenter, Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03185845
- Acronym / sponsor ID
- 2016YFC1304402B
- Conditions
- COPD Exacerbation, PTE - Pulmonary Thromboembolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged anticoagulation | Experimental | Drug: Warfarin3 months longer anticoagulation after regular treatment |
| Regular anticoagulation | No intervention | –stop anticoagulation after regular treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with major bleeding during prior anticoagulation
- Patients need long term anticoagulation to treat other diseases
- Patients unwilling to receive prolonged anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarintailored dose according to international normalized ratio (INR) for 3 months | Drug | Prolonged anticoagulation |
Primary outcome
Venous thromboembolism recurrence
Time frame: 3 years
recurrence rate in %
1 secondary outcome
Chronic obstructive pulmonary disease exacerbations
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin in people with COPD Exacerbation and PTE - Pulmonary Thromboembolism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanhua Yang, MD (13911773607, yyh1031@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism recurrence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.