Trial Outcomes & Findings for Pulmonary Embolism as a Cause of COPD Exacerbations (NCT NCT02238639)

NCT ID: NCT02238639

Last Updated: 2022-12-01

Results Overview

Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 746 participants
• Primary outcome timeframe: 90-day follow-up
• Results posted on: 2022-12-01

Participant Flow

Participant milestones

Measure	Active Search for Pulmonary Embolism All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Overall Study STARTED	374	372
Overall Study COMPLETED	370	367
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pulmonary Embolism as a Cause of COPD Exacerbations

Baseline characteristics by cohort

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.	Total n=737 Participants Total of all reporting groups
Age, Continuous	70.2 years STANDARD_DEVIATION 9.9 • n=5 Participants	70.6 years STANDARD_DEVIATION 9.9 • n=7 Participants	70.3 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	109 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	284 Participants n=5 Participants	258 Participants n=7 Participants	542 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	370 Participants n=5 Participants	367 Participants n=7 Participants	737 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	370 participants n=5 Participants	367 participants n=7 Participants	737 participants n=5 Participants

PRIMARY outcome

Timeframe: 90-day follow-up

Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.

Outcome measures

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.	110 Participants	107 Participants

SECONDARY outcome

Timeframe: 90-day follow-up

All-cause mortality.

Outcome measures

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
All-cause Mortality	23 participants	29 participants

SECONDARY outcome

Timeframe: 90-day follow-up

Symptomatic venous thromboembolic recurrence confirmed by objective testing.

Outcome measures

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Symptomatic Recurrent Venous Thromboembolism	2 participants	9 participants

SECONDARY outcome

Timeframe: 90-day follow-up

Need for readmission.

Outcome measures

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Hospitalization	94 participants	84 participants

SECONDARY outcome

Timeframe: 90-day follow-up

Major bleeding (defined according to previously published criteria)

Outcome measures

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Major Bleeding	3 participants	3 participants

SECONDARY outcome

Timeframe: 90-day follow-up

Clinically relevant non major bleeding (defined according to previously published criteria)

Outcome measures

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Clinically Relevant Non Major Bleeding	1 participants	1 participants

SECONDARY outcome

Timeframe: 90-day follow-up

Serious adverse events.

Outcome measures

Measure	Active Search for Pulmonary Embolism n=370 Participants All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 Participants All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Serious Adverse Events	18 participants	18 participants

Adverse Events

Active Search for Pulmonary Embolism

Serious events: 18 serious events

Other events: 0 other events

Deaths: 23 deaths

Standard Management

Serious events: 18 serious events

Other events: 0 other events

Deaths: 29 deaths

Serious adverse events

Measure	Active Search for Pulmonary Embolism n=370 participants at risk All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).: If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.	Standard Management n=367 participants at risk All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Investigations SAEs	4.9% 18/370 • Number of events 18 • 3 months. Please see protocol.	4.9% 18/367 • Number of events 18 • 3 months. Please see protocol.

Other adverse events

Adverse event data not reported

Additional Information

David Jimenez

Hospital Ramon y Cajal

Phone: +34913368133

Email: djimenez.hrc@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60