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Calf Deep Vein Thrombosis Treatment Trial

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ClinicalTrials.gov Identifier: NCT03590743
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : March 12, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Information provided by (Responsible Party):
Robert D. McBane, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: Apixaban Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, randomized, double blind, placebo-controlled, superiority clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind, placebo controlled
Primary Purpose: Treatment
Official Title: A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Active Comparator: Apixaban
Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).
Drug: 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.
Other Name: Eliquis

Placebo Comparator: Placebo
Patients will receive matching placebo.
Other: Placebo
apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. Mean Time of Thrombus Propagation [ Time Frame: Within 3 months of therapy initiation ]
    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 DVT diagnosis for this purpose.

  2. Net Clinical Benefit or Harm for the Two Strategies [ Time Frame: Within 3 months of therapy initiation. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Age range: ≥ 18 years.
  2. Both males and females
  3. Confirmed acute calf vein thrombosis confined to either the deep (posterior tibial, anterior tibial, or peroneal) or muscular (gastrocnemius or soleal) veins.
  4. 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.
  5. Ability to provide written informed consent.

Exclusion criteria

  1. 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.

    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
  2. 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.
  3. Age < 18 years.
  4. Continuous treatment with therapeutic anticoagulant for more than 72 hours pre-randomization.
  5. Contraindication to anticoagulant therapy
  6. 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)
  7. 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)
  8. Platelet count < 50 x109/L.(within last four weeks)
  9. Life expectancy < 12 months.
  10. Current active bleeding.
  11. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers like rifampicin.
  12. 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).
  13. . Anticipated need for urgent/emergent surgery or major invasive procedure.
  14. Dual antiplatelet therapy (thienopyridine plus aspirin) and/or aspirin greater than 165 mg while on study medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590743


Contacts
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Contact: Dawn Shelstad 507-255-0473 shelstad.dawn@mayo.edu
Contact: Trevor Stromme 507-293-2754 Stromme.Trevor@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Mayo Clinic Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Andrew Calvin, MD    715-838-6836    calvin.andrew@mayo.edu   
Contact: Holly Hennlich    715-464-8172    hennlich.holly@mayo.edu   
Mayo Clinic Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Carolyn R Flock    608-392-9462    Flock.Carolyn@mayo.edu   
Contact: Patsy Cacerers Figueroa    608-392-9280    caceresfigueroa.patsy@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Bristol-Myers Squibb
Pfizer
Investigators
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Principal Investigator: Robert D McBane Mayo Clinic

Additional Information:
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Responsible Party: Robert D. McBane, Director Vascular Medicine Division, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03590743     History of Changes
Other Study ID Numbers: 17-009022
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants