MedTrace Logo

The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis

NCT04981327 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2021-07-29

No results posted yet for this study

Summary

Isolated distal DVT (iDDVT) is the most frequent clinical presentation of VTE and is associated with a significant morbidity and risks of long-term complications. Data from clinical trials highlighted that patients with iDDVT might require some level of AC treatment. However, the optimal anticoagulant intensity is uncertain, and it is plausible that the best benefit/risk ratio for AC might be achieved with lower intensity doses rather than therapeutic doses.

The principal research question of the Apixaban to treat calf vein thrombosis (API-CALF) study is to determine whether, after a conventional course of 7 days of Apixaban 10mg BID, Apixaban 2.5mg BID (experimental arm) is non inferior to Apixaban 5 mg BID (standard arm) in preventing VTE recurrence and bleeding in patients with iDDVT. Patients will be treated with Apixaban for a total of 3 months. In that perspective we will conduct an international multicentre open-label assessor-blinded study

Conditions

  • Deep Vein Thrombosis

Interventions

DRUG

Apixaban 2.5 MG Oral Tablet [ELIQUIS]

Apixaban 5 MG BID versus Apixaban 2.5 MG BID

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Jean-Philippe Galanaud, MD, PhD · Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Canada

  • Marc Righini, MD · Geneva University Hospital, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-08-31
Completion
2027-08-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04981327 on ClinicalTrials.gov