Trial Outcomes & Findings for Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism (NCT NCT04168203)

Last Updated: 2025-11-14

Results Overview

DVT is diagnosed as a newly non-compressible venous segment or segments on ultrasonography or a filling defect on computed tomographic (CT) venography, magnetic resonance (MR) venography, or contrast venography. PE is diagnosed based on new mismatched perfusion defect(s) on ventilation perfusion scan, the presence of a new pulmonary artery filling defect on contrast-enhanced chest CT, a new finding of intraluminal filling defect on invasive pulmonary angiography, or evidence of PE at autopsy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

600 participants

Primary outcome timeframe

12 months

Results posted on

2025-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Extended Duration Thromboprophylaxis apixaban 2.5 mg orally twice daily for a duration of 12 months Apixaban 2.5 MG: apixaban 2.5 mg orally twice daily for a duration of 12 months	Control oral placebo for a duration of 12 months Placebo oral tablet: placebo oral tables twice daily for a duration of 12 months
Overall Study STARTED	300	300
Overall Study COMPLETED	300	300
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Duration Thromboprophylaxis n=300 Participants apixaban 2.5 mg orally twice daily for a duration of 12 months Apixaban 2.5 MG: apixaban 2.5 mg orally twice daily for a duration of 12 months	Control n=300 Participants oral placebo for a duration of 12 months Placebo oral tablet: placebo oral tables twice daily for a duration of 12 months	Total n=600 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	200 Participants n=10 Participants	200 Participants n=10 Participants	400 Participants n=20 Participants
Age, Categorical >=65 years	100 Participants n=10 Participants	100 Participants n=10 Participants	200 Participants n=20 Participants
Age, Continuous	59.1 years STANDARD_DEVIATION 15.2 • n=10 Participants	59.9 years STANDARD_DEVIATION 15.2 • n=10 Participants	59.5 years STANDARD_DEVIATION 15.2 • n=20 Participants
Sex: Female, Male Female	176 Participants n=10 Participants	166 Participants n=10 Participants	342 Participants n=20 Participants
Sex: Female, Male Male	124 Participants n=10 Participants	134 Participants n=10 Participants	258 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	4 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	33 Participants n=10 Participants	37 Participants n=10 Participants	70 Participants n=20 Participants
Race (NIH/OMB) White	246 Participants n=10 Participants	239 Participants n=10 Participants	485 Participants n=20 Participants
Race (NIH/OMB) More than one race	1 Participants n=10 Participants	3 Participants n=10 Participants	4 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=10 Participants	20 Participants n=10 Participants	36 Participants n=20 Participants
Region of Enrollment United States	300 participants n=10 Participants	300 participants n=10 Participants	600 participants n=20 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Extended Duration Thromboprophylaxis n=300 Participants apixaban 2.5 mg orally twice daily for a duration of 12 months Apixaban 2.5 MG: apixaban 2.5 mg orally twice daily for a duration of 12 months	Control n=300 Participants oral placebo for a duration of 12 months Placebo oral tablet: placebo oral tables twice daily for a duration of 12 months
Frequency of Symptomatic, Recurrent VTE Defined as the Composite of Deep Vein Thrombosis and/or Pulmonary Embolism	4 Participants	30 Participants

PRIMARY outcome

Timeframe: 12 months

Defined as overt bleeding that is associated with a decrease in the hemoglobin level ≥ 2 g/dL, leads to transfusion ≥ 2 units of packed red blood cells, occurs in a critical site, or contributes to death

Outcome measures

Outcome measures
Measure	Extended Duration Thromboprophylaxis n=300 Participants apixaban 2.5 mg orally twice daily for a duration of 12 months Apixaban 2.5 MG: apixaban 2.5 mg orally twice daily for a duration of 12 months	Control n=300 Participants oral placebo for a duration of 12 months Placebo oral tablet: placebo oral tables twice daily for a duration of 12 months
Frequency of Major Bleeding	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

An acute MI is defined as the presence of at least 2 of 3 following conditions (29): * Cardiac biomarkers, with at least one of the values being elevated with at least one value above the 99th percentile upper reference limit) and with at least one of the following: * symptoms of myocardial ischemia * new (or presumably new) significant ST-segment/T-wave changes or left bundle branch block * development of pathological Q waves on ECG * new loss of viable myocardium or regional wall motion abnormality by imaging * identification of intracoronary thrombus by angiography or autopsy An acute stroke is defined as a new, focal neurologic deficit of sudden onset, lasting at least 24 hours confirmed by a neurologist and neuroimaging (7). Cardiovascular death is defined as a death for which a definite non-cardiovascular cause (e.g. cancer) has not been identified. Major adverse limb events include acute limb ischemia (ALI) and critical limb ischemia (CLI) (30).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Overt bleeding that does not meet the criteria for major bleeding but that is associated with the need for medical intervention, unscheduled contact with a physician, interruption or discontinuation of the study drug, or discomfort or impairment of activities of daily living

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Total number of doses taken divided by the total number of doses prescribed

Outcome measures

Outcome data not reported

Adverse Events

Extended Duration Thromboprophylaxis

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

Control

Serious events: 0 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Extended Duration Thromboprophylaxis n=300 participants at risk apixaban 2.5 mg orally twice daily for a duration of 12 months Apixaban 2.5 MG: apixaban 2.5 mg orally twice daily for a duration of 12 months	Control n=300 participants at risk oral placebo for a duration of 12 months Placebo oral tablet: placebo oral tables twice daily for a duration of 12 months
General disorders Adverse Drug Reactions	2.0% 6/300 • Number of events 6 • 1 year Definitions do not differ	2.0% 6/300 • Number of events 6 • 1 year Definitions do not differ

Additional Information

Physician

BWH

Phone: 6177326984

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place