Calf Deep Vein Thrombosis Treatment Trial

NCT03590743 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-009022
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 3 months of therapy initiation

Secondary Outcomes (2)

• Mean Time of Thrombus Propagation

  Within 3 months of therapy initiation

• Net Clinical Benefit or Harm for the Two Strategies

  Within 3 months of therapy initiation.

Study Arms (2)

Apixaban

ACTIVE COMPARATOR

Apixaban 5mg (10 mg twice daily for 7 days followed by 5 mg twice daily for 3 months).

Drug: Apixaban

Placebo

PLACEBO COMPARATOR

Patients will receive matching placebo.

Other: Placebo

Interventions

Apixaban DRUG

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.

Also known as: Eliquis

Apixaban

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Bristol-Myers Squibb: collaborator
• Pfizer: collaborator

Study Sites (3)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic

La Crosse, Wisconsin, 54601, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Venous Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study was terminated due to lack of subjects enrollment

Results Point of Contact

• Title: Robert D. McBane, II M.D.
• Organization: Mayo Clinic

mcbane.robert@mayo.edu

507-266-3964

Study Officials

• Robert D McBane

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Vascular Medicine Division, Professor of Medicine

Model Details: Multicenter, randomized, double blind, placebo-controlled, superiority clinical trial.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 18, 2018
• Study Start: February 19, 2019
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Locations

US (3)