Deep Vein ThrombosisPhase 4NCT03590743

Calf Deep Vein Thrombosis Treatment Trial

A Phase 4 study testing Apixaban in people with Deep Vein Thrombosis, run by Mayo Clinic at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The primary objective is to evaluate whether apixaban is more effective in treating patients with isolated calf vein thrombosis (DVT) than serial imaging of the DVT for preventing thrombus spread, pulmonary embolism (PE) and/or recurring DVTs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Deep Vein Thrombosis
What is being tested?: Apixaban
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 3 sitesUnited States
Study dates: 19 Feb 2019to 3 Jun 2019
Phase: Phase 4
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

Age range: ≥ 18 years.
Both males and females
Confirmed acute calf vein thrombosis confined to either the deep (posterior tibial, anterior tibial, or peroneal) or muscular (gastrocnemius or soleal) veins.
Negative serum or urine pregnancy test done (within 2 weeks) prior to randomization, for women of childbearing potential only. Note: A woman 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 provide written informed consent.

Who cannot join

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
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.
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.

Show all 29Show fewer

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. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence
Acute co-existing proximal DVT (popliteal, femoral, iliac veins or IVC), pulmonary embolism, splanchnic vein thrombosis, cerebral venous sinus thrombosis within the past 3 months for whom anticoagulation therapy is indicated.
Age < 18 years.
Continuous treatment with therapeutic anticoagulant for more than 72 hours pre-randomization.
Contraindication to anticoagulant therapy
Significant kidney disease. Creatinine clearance < 25 ml/min using the Cockcroft-Gault equation: glomerular filtration rate (GFR) = (140-age) * (Wt in kg) * (0.85 if female) / (72 * Cr). (within last four weeks)
Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) (or AST) > 3 x upper limit of normal (ULN). (within last four weeks)
Platelet count < 50 x109/L.(within last four weeks)
Life expectancy < 12 months.
Current active bleeding.
Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers like rifampicin.
Active cancer defined as any evidence of cancer on cross-sectional imaging or cancer treatments within the past 6 months (chemotherapy, radiation therapy or cancer related surgery).
. Anticipated need for urgent/emergent surgery or major invasive procedure.
Dual antiplatelet therapy (thienopyridine plus aspirin) and/or aspirin greater than 165 mg while on study medication.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Mayo Clinic
Eau Claire, Wisconsin, 54701
Mayo Clinic
La Crosse, Wisconsin, 54601
Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis

Read the detailed description

This is a randomized double-blind placebo controlled superiority clinical trial. Patients will be identified at the time of the diagnosis of acute calf deep vein thrombosis and approached at that time. If they agree they would be randomly assigned to placebo or apixaban treatment for three months. Along with this they will also undergo repeat ultrasounds at 7, 14, and 90 days along with telephone follow-up at 30 and 60 days.

Conditions: Deep Vein Thrombosis
Being tested: Apixaban, Placebo
Medical subject headings: Venous Thrombosis

What participants receive

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

ApixabanDrug
Also called Eliquis
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.
PlaceboOther
apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.

Study groups in NCT03590743
Study group	Role	What they receive
Apixaban	Active comparator	Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months). Receives: Drug: Apixaban
Placebo	Placebo comparator	Patients will receive matching placebo. Receives: Other: Placebo

What is being measured

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

Number of Subjects Who Experience a Composite Venous Thromboembolism (VTE) Event Within 3 Months
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.
Measured: Within 3 months of therapy initiation
Number of Subjects Who Experience Either Major Bleeding or Clinically Relevant Non-major Bleeding Within 3 Months
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.
Measured: Within 3 months of therapy initiation

Secondary outcomes (2)

Mean Time of Thrombus Propagation
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.
Measured: Within 3 months of therapy initiation
Net Clinical Benefit or Harm for the Two Strategies
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.
Measured: Within 3 months of therapy initiation.

Timeline

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

19 Feb 20193 Jun 2019

First posted18 Jul 2018
Study start19 Feb 2019
Primary completion3 Jun 2019
Study completion3 Jun 2019

Why it stopped: Lack of participant enrollment

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.
Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Model description: Multicenter, randomized, double blind, placebo-controlled, superiority clinical trial.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03590743
Sponsor's protocol ID: 17-009022
Status last verified: Mar 2020
First submitted: 5 Jun 2018
Last updated: 25 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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

RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis

All Deep Vein Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis
ClinicalTrials.gov ID: NCT03590743
Acronym / sponsor ID: 17-009022
Conditions: Deep Vein Thrombosis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of participant enrollment
Enrolment: 5 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Bristol-Myers Squibb, Pfizer
Study start: 19 Feb 2019 (actual)
Primary completion: 3 Jun 2019 (actual)
Study completion: 3 Jun 2019 (actual)
First posted: 18 Jul 2018 (actual)
Results: Posted 25 Mar 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Multicenter, randomized, double blind, placebo-controlled, superiority clinical trial.

Arm	Type	Receives
Apixaban	Active comparator	Drug: ApixabanApixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).
Placebo	Placebo comparator	Other: PlaceboPatients will receive matching placebo.

Who may qualify

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

Key inclusion criteria (5 listed)

Age range: ≥ 18 years.
Both males and females
Confirmed acute calf vein thrombosis confined to either the deep (posterior tibial, anterior tibial, or peroneal) or muscular (gastrocnemius or soleal) veins.
Negative serum or urine pregnancy test done (within 2 weeks) prior to randomization, for women of childbearing potential only. Note: A woman 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 provide written informed consent.

Key exclusion criteria (29 listed)

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
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.
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:

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: EliquisActive anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment.	Drug	Apixaban
Placeboapixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.	Other	Placebo

Primary outcome

Number of Subjects Who Experience a Composite Venous Thromboembolism (VTE) Event Within 3 Months
Time frame: Within 3 months of therapy initiation
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.
Number of Subjects Who Experience Either Major Bleeding or Clinically Relevant Non-major Bleeding Within 3 Months
Time frame: Within 3 months of therapy initiation
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.

2 secondary outcomes

Mean Time of Thrombus Propagation
Time frame: Within 3 months of therapy initiation
Net Clinical Benefit or Harm for the Two Strategies
Time frame: Within 3 months of therapy initiation.

Results and safety

Results posted to the registry on 25 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apixaban	2	2
Placebo	3	2

Primary outcome: Number of Subjects Who Experience a Composite Venous Thromboembolism (VTE) Event Within 3 Months

Time frame: Within 3 months of therapy initiation

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

Primary outcome: Number of Subjects Who Experience Either Major Bleeding or Clinically Relevant Non-major Bleeding Within 3 Months

Time frame: Within 3 months of therapy initiation

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for approximately 3 mos post enrollment for each subject. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apixaban	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Placebo	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): Study was terminated due to lack of subjects enrollment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

Related trials for Deep Vein Thrombosis

RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
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DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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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 D McBane principal investigator

Mayo Clinic

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apixaban in people with Deep Vein Thrombosis, run by Mayo Clinic at 3 sites in United States.

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 5 inclusion and 29 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: stopped early, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 25 Mar 2020). 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?

Number of Subjects Who Experience a Composite Venous Thromboembolism (VTE) Event Within 3 Months (time frame: Within 3 months of therapy initiation). The study lists 2 primary outcomes in all. 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 NCT03590743.

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 25 Mar 2020.