Trial Outcomes & Findings for Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism (NCT NCT00423683)

Results Overview

Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

64 participants

Primary outcome timeframe

3 years or until death

Results posted on

2016-06-08

Participant Flow

recruitment was slowed due to newly approved medications so study was stopped early.

Participant milestones

Participant milestones
Measure	2 Arixtra+ Filter Arixtra subq injection + IVC filter	1-Arixtra Alone Arixtra treatment without inferior vena cava filter
Overall Study STARTED	31	33
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2 Arixtra+ Filter n=31 Participants Arixtra subq injection + IVC filter	1- Arixtra Alone n=33 Participants Arixtra treatment without inferior vena cava filter	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	21 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 2 • n=5 Participants	67 years STANDARD_DEVIATION 14 • n=7 Participants	65 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	24 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	33 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years or until death

Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs

Outcome measures

Outcome measures
Measure	Arixtra n=33 Participants	Arixtra and Filter n=31 Participants
Adverse Outcomes	15.2 percentage of participants	16.1 percentage of participants

SECONDARY outcome

Timeframe: 3 years or until death

Outcome measures

Outcome measures
Measure	Arixtra n=33 Participants	Arixtra and Filter n=31 Participants
Overall Survival	493 days Interval 141.0 to 744.0	266 days Interval 118.0 to 426.0

SECONDARY outcome

Timeframe: 3 years or until death

Population: 33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites

Outcome measures

Outcome measures
Measure	Arixtra n=59 DVT sites	Arixtra and Filter n=48 DVT sites
Resolution of DVT	61.0 percentage of DVT sites	37.5 percentage of DVT sites

SECONDARY outcome

Timeframe: 3 years or until death

Population: 33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites

Outcome measures

Outcome measures
Measure	Arixtra n=25 PE sites	Arixtra and Filter n=18 PE sites
Resolution of PE	32.0 percentage of PE sites	66.7 percentage of PE sites

Adverse Events

2 Arixtra+ Filter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arixtra Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valerie Blake

North Shore LIJ Health System

Phone: 516-562-0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60