Trial Outcomes & Findings for Calf Deep Vein Thrombosis Treatment Trial (NCT NCT03590743)

Results Overview

The composite VTE event will include thrombus propagation either within the calf veins or into proximal deep veins (popliteal, femoral or iliac veins), symptomatic or incidental VTE recurrence or all-cause mortality within 3 months of therapy initiation. All suspected VTE events will be evaluated by a central, blinded, independent adjudication committee.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Within 3 months of therapy initiation

Results posted on

2020-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Apixaban Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months). Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment.	Placebo Patients will receive matching placebo. Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Apixaban Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months). Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment.	Placebo Patients will receive matching placebo. Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apixaban n=2 Participants Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months). Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment.	Placebo n=3 Participants Patients will receive matching placebo. Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.	Total n=5 Participants Total of all reporting groups
Age, Continuous	77 years STANDARD_DEVIATION 9.9 • n=2 Participants	60 years STANDARD_DEVIATION 17.69 • n=3 Participants	67.3 years STANDARD_DEVIATION 16.36 • n=5 Participants
Sex: Female, Male Female	2 Participants n=2 Participants	1 Participants n=3 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=2 Participants	2 Participants n=3 Participants	2 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	3 participants n=3 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 months of therapy initiation

Population: Study terminated due to lack of subject enrollment. Data was not analyzed.

The composite VTE event will include thrombus propagation either within the calf veins or into proximal deep veins (popliteal, femoral or iliac veins), symptomatic or incidental VTE recurrence or all-cause mortality within 3 months of therapy initiation. All suspected VTE events will be evaluated by a central, blinded, independent adjudication committee.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Within 3 months of therapy initiation

Population: Study terminate to due lack of subject enrollment. Data was not analyzed.

Major bleeding is defined as overt bleeding plus a hemoglobin decrease of ≥ 2 g/dL or transfusion of ≥ 2 units of packed red blood cells, or bleeding at a critical site: intracranial, intraspinal, intraocular, retroperitoneal, pericardial intra-articular, intramuscular with compartment syndrome, or fatal bleeding. Clinically relevant non-major bleeding is defined as any overt, actionable sign of hemorrhage meeting at least one of the following criteria: (i) requiring nonsurgical, medical intervention by a healthcare professional, (ii) leading to hospitalization or increased level of care, or (iii) prompting evaluation. All patients who received at least one dose of study medication will be included in the safety analysis. All suspected bleeding events will be evaluated by a central, blinded, independent adjudication committee.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 3 months of therapy initiation

Population: Study terminated due to lack of subject enrollment. Data was not analyzed.

The timing of thrombus propagation for those individuals who have suffered such an event. The date of thrombus propagation confirmation will be compared to the date of the original Deep Vein Thrombosis (DVT) diagnosis for this purpose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 3 months of therapy initiation.

Population: Study terminated to due lack of subject enrollment. Data was not analyzed.

The outcome of net clinical benefit or harm will be assessed as the composite of the primary efficacy outcome or the principal safety outcome up to day 90. The difference in the incidences of the combined endpoint at 3 months between treatment arms will be estimated and tested using a normal approximation of the binomial distribution. All tests will be conducted at the two-sided 0.05 significance level.

Outcome measures

Outcome data not reported

Adverse Events

Apixaban

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Apixaban n=2 participants at risk Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months). Apixaban: Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment.	Placebo n=3 participants at risk Patients will receive matching placebo. Placebo: apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.
Vascular disorders Nose Bleed	100.0% 2/2 • Number of events 2 • Adverse events were collected for approximately 3 mos post enrollment for each subject	0.00% 0/3 • Adverse events were collected for approximately 3 mos post enrollment for each subject
Respiratory, thoracic and mediastinal disorders Shortness of Breath	50.0% 1/2 • Number of events 1 • Adverse events were collected for approximately 3 mos post enrollment for each subject	0.00% 0/3 • Adverse events were collected for approximately 3 mos post enrollment for each subject

Additional Information

Robert D. McBane, II M.D.

Mayo Clinic

Phone: 507-266-3964

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place