Cerebral Vein ThrombosisPhase 3NCT02585713

Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism

A Phase 3 study testing Apixaban, Dalteparin and Questionnaire Administration in people with Cerebral Vein Thrombosis and Deep Vein Thrombosis, run by Academic and Community Cancer Research United at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cerebral Vein Thrombosis, Deep Vein Thrombosis, Gonadal Thrombosis
What is being tested?: Apixaban, Dalteparin and Questionnaire Administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 18 sitesUnited States
Study dates: 20 Nov 2015to 24 Dec 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed acute lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis
Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; note: non-melanoma skin cancer does not meet the cancer requirement
Life expectancy >= 60 days
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
Obtained =< 30 days prior to randomization: Platelet count >= 50,000/mm^3
Obtained =< 30 days prior to randomization: Alanine aminotransferase (ALT) or aspartate transaminase (AST) =< 3 x upper limit of normal (ULN)

Show all 12Show fewer

Obtained =< 30 days prior to randomization: International normalized ratio (INR) =< 1.6 (if not taking anticoagulant therapy)
Obtained =< 30 days prior to randomization: Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula
Negative serum or urine pregnancy test done =< 24 hours prior to randomization, for women of childbearing potential only; note: a women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal; menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes
Ability to complete questionnaire(s) by themselves or with assistance
Ability to provide informed written consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Who cannot join

Any of the following:
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Note: women of child bearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 33 days after finishing the last dose
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 93 days after finishing the last dose

Show all 40Show fewer

Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however they must still undergo pregnancy testing as described in this section
Note: investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly
At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:
HIGHLY EFFECTIVE METHODS OF CONTRACEPTION
Male condoms with spermicide
Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject?s WOCBP partner
Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug
IUDs, such as ParaGard
Tubal ligation
Vasectomy
Complete abstinence
Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence
Treatment with an anticoagulant for more than 7 days for the current blood clot, prior to randomization
Active bleeding
Severe hypersensitivity reaction to apixaban, dalteparin, heparin or pork products (e.g., anaphylactic reactions)
Use of the following CYP3A4 inducers: rifampin, rifabutin, carbamazepine, efavirenz, phenobarbital, phenytoin, fosphenytoin, primidone, and St. John?s wort)
Thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
Use of a Factor Xa inhibitor (e.g. apixaban, rivaroxaban, or edoxaban) =< 3 months prior to randomization
Treatment of a thromboembolic event =< 6 months prior to randomization
Documented venous thromboembolism while on therapeutic anticoagulation (?anticoagulation failure?)
Mechanical heart valve
Documented hemorrhagic tendencies
Bacterial endocarditis
History of heparin induced thrombocytopenia
Any of the following conditions:
Intracranial bleeding =< 6 months prior to randomization
Intraocular bleeding =< 6 months prior to randomization
Gastrointestinal bleeding and/or endoscopically proven ulcer =< 6 months prior to randomization
Head trauma or major trauma =<1 month prior to randomization
Neurosurgery =< 2 weeks prior to randomization
Major surgery =< 1 week prior to randomization
Overt major bleeding at the time of randomization
Gross hematuria at the time of randomization

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, 03106
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, 28374
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Mayo Clinic
Rochester, Minnesota, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism

This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism.

ADAM-VTE

Read the detailed description

PRIMARY OBJECTIVES:

Any episode of major bleeding including fatal bleeding.

SECONDARY OBJECTIVES:

Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism.

II. Any episode of major bleeding including fatal bleeding or any episode of clinically relevant non-major bleeding.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.

ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC) once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.

After completion of study treatment, patients are followed up at 3 months.

Conditions: Cerebral Vein Thrombosis, Deep Vein Thrombosis, Gonadal Thrombosis, Hepatic Thrombosis, Malignant Neoplasm, Mesenteric Thrombosis
Being tested: Apixaban, Dalteparin, Questionnaire Administration
Medical subject headings: Intracranial Thrombosis, Venous Thrombosis, Neoplasms, Mesenteric Ischemia, Neoplasm Metastasis, Pulmonary Embolism, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApixabanDrug
Also called BMS-562247, BMS-562247-01, Eliquis
Given PO
DalteparinDrug
Given SC
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT02585713
Study group	Role	What they receive
Arm I (apixaban)	Experimental	Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180. Receives: Drug: Apixaban; Other: Questionnaire Administration
Arm II (dalteparin)	Experimental	Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180. Receives: Drug: Dalteparin; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

6 Month Bleeding Rate
The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.
Measured: Up to 6 months

Secondary outcomes (2)

Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed
A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.
Measured: Up to 6 months
Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE).
Measured: Up to 3 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201524 Dec 2019

First posted23 Oct 2015 (estimated)
Study start20 Nov 2015
Primary completion2 Apr 2018
Study completion24 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cerebral Vein ThrombosisStudies 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 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02585713
Sponsor's protocol ID: RU221501I
Other IDs: NCI-2015-01573, CV185-444, RU221501I
Status last verified: Jun 2019
First submitted: 22 Oct 2015
Last updated: 4 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.
PubMed 31630479
McBane Ii R, Loprinzi CL, Ashrani A, Perez-Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Le-Rademacher JG, Wysokinski WE. Apixaban and dalteparin in active malignancy associated venous thromboembolism. The ADAM VTE Trial. Thromb Haemost. 2017 Oct 5;117(10):1952-1961. doi: 10.1160/TH17-03-0193. Epub 2017 Aug 24.
PubMed 28837207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Vein Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
ClinicalTrials.gov ID: NCT02585713
Acronym / sponsor ID: RU221501I
Conditions: Cerebral Vein Thrombosis, Deep Vein Thrombosis, Gonadal Thrombosis, Hepatic Thrombosis, Malignant Neoplasm, Mesenteric Thrombosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Academic and Community Cancer Research UnitedUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 20 Nov 2015 (actual)
Primary completion: 2 Apr 2018 (actual)
Study completion: 24 Dec 2019 (actual)
First posted: 23 Oct 2015 (estimated)
Results: Posted 24 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

ADAM-VTE

Detailed description

PRIMARY OBJECTIVES:

Any episode of major bleeding including fatal bleeding.

SECONDARY OBJECTIVES:

Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism.

II. Any episode of major bleeding including fatal bleeding or any episode of clinically relevant non-major bleeding.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.

ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC) once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.

After completion of study treatment, patients are followed up at 3 months.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (apixaban)	Experimental	Drug: Apixaban, Other: Questionnaire AdministrationPatients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
Arm II (dalteparin)	Experimental	Drug: Dalteparin, Other: Questionnaire AdministrationPatients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Confirmed acute lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis
Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; note: non-melanoma skin cancer does not meet the cancer requirement
Life expectancy >= 60 days
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
Obtained =< 30 days prior to randomization: Platelet count >= 50,000/mm^3

Key exclusion criteria (40 listed)

Any of the following:
Note: investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly
At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:
Treatment with an anticoagulant for more than 7 days for the current blood clot, prior to randomization
Active bleeding

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
ApixabanAlso: BMS-562247, BMS-562247-01, EliquisGiven PO	Drug	Arm I (apixaban)
DalteparinGiven SC	Drug	Arm II (dalteparin)
Questionnaire AdministrationAncillary studies	Other	Arm I (apixaban), Arm II (dalteparin)

Primary outcome

6 Month Bleeding Rate
Time frame: Up to 6 months
The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.

2 secondary outcomes

Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed
Time frame: Up to 6 months
Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
Time frame: Up to 3 months post-treatment

Results and safety

Results posted to the registry on 24 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A (Apixaban)	150	145
Arm B (Dalteparin)	150	142

Primary outcome: 6 Month Bleeding Rate

Time frame: Up to 6 months. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Arm A (Apixaban) n = 145	Arm B (Dalteparin) n = 142
Value	0 (0 to 0)	2.1 (0.6 to 6.6)

Population analysed: Primary Analysis Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 months after completion of treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A (Apixaban)	62 of 148 (41.9%)	78 of 148 (52.7%)	35 of 148
Arm B (Dalteparin)	51 of 143 (35.7%)	71 of 143 (49.7%)	25 of 143

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31630479McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.
Derived from this study: PubMed 28837207McBane Ii R, Loprinzi CL, Ashrani A, Perez-Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Le-Rademacher JG, Wysokinski WE. Apixaban and dalteparin in active malignancy associated venous thromboembolism. The ADAM VTE Trial. Thromb Haemost. 2017 Oct 5;117(10):1952-1961. doi: 10.1160/TH17-03-0193. Epub 2017 Aug 24.

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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.

Robert McBane principal investigator

Academic and Community Cancer Research United

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 40 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: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Month Bleeding Rate (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585713, which also lists 2 linked publications.

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 4 Aug 2020.