Calf Deep Vein Thrombosis Treatment Trial

NCT03590743

Last updated date
Study Location
Mayo Clinic
Eau Claire, Wisconsin, 54701, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Deep Vein Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Deep Vein ThrombosisCalf Deep Vein Thrombosis Treatment Trial
NCT03590743
  1. Eau Claire, Wisconsin
  2. La Crosse, Wisconsin
  3. Rochester, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Calf Deep Vein Thrombosis Treatment Trial
Official Title  ICMJE A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Deep Vein Thrombosis
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: Apixaban
    Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).
    Intervention: Drug: Apixaban
  • Placebo Comparator: Placebo
    Patients will receive matching placebo.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2020)
5
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
250
Actual Study Completion Date  ICMJE June 3, 2019
Actual Primary Completion Date June 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03590743
Other Study ID Numbers  ICMJE 17-009022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert D. McBane, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Pfizer
Investigators  ICMJE
Principal Investigator:Robert D McBaneMayo Clinic
PRS Account Mayo Clinic
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP