Golden Calf Trial

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-009022
    • La Crosse, Wisconsin: 17-009022
    • Eau Claire, Wisconsin: 17-009022
    NCT ID: NCT03590743
    Sponsor Protocol Number: 17-009022

About this study

The purpose of this study is to determine whether prescribing apixaban (Eliquis®) is more effective in treating and preventing pulmonary embolisms and subsequent DVTs than monitoring the calf DVT with ultrasound imaging alone.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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 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.
  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
  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: 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 ALT (or AST) > 3 x 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 CYP 3A4 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.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert McBane, M.D.

Closed for enrollment

Contact information:

Dawn Shelstad

(507)255-0473

shelstad.dawn@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Robert McBane, M.D.

Closed for enrollment

Contact information:

Patsy Caceres Figueroa

(608)392-9280

CaceresFigueroa.Patsy@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Robert McBane, M.D.

Closed for enrollment

Contact information:

Holly Hennlich

(715)464-8172

Hennlich.Holly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20423643

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