NCT02559856

Brief Summary

This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood thinners for the treatment of blood clots. Half of the patients will receive apixaban and half will receive rivaroxaban. The main objective is to determine the feasibility of patient recruitment and resources required to follow enrolled patients and inform for a larger, multi-centered trial and to assess which one is safer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

September 21, 2015

Last Update Submit

November 14, 2025

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (4)

  • Proportion of patients screened who are eligible to participate in the trial

    Assessing clinical feasibility for a larger multi-center trial - number of screened patients versus eligible patients

    For the duration of the study 3-6 months

  • Proportion of eligible patients who consent to participate in the trial

    Assessing clinical feasibility for a larger multi-center trial - number of eligible patients versus patients who consent to participate

    For the duration of the study 3-6 months

  • Proportion of patients who attend each follow-up visit

    Assessing clinical feasibility for a larger multi-center trial - number of patients that miss visits versus patients that attend visits.

    For the duration of the study 3-6 months

  • Proportion of patients completing all required study procedures, per follow-up visit

    Assessing clinical feasibility for a larger multi-center trial - number of patients that complete all required procedures/study visits versus patients that do not.

    For the duration of the study 3-6 months

Secondary Outcomes (5)

  • Bleeding Events

    For the duration of the study 3-6 months

  • Venous Thromboembolism

    For the duration of the study 3-6 months

  • Death

    For the duration of the study 3-6 months

  • Medication compliance

    For the duration of the study 3-6 months

  • Time-to-event analysis

    For the duration of the study 3-6 months

Study Arms (2)

Apixaban

ACTIVE COMPARATOR

10 mg PO twice-a-day for 1 week, then 5 mg PO, twice daily for 3 or 6 months of treatment.

Drug: Apixaban

Rivaroxaban

ACTIVE COMPARATOR

15 mg PO twice-a-day for 3 weeks, then 20 mg PO once daily for 3 or 6 months of treatment.

Drug: Rivaroxaban

Interventions

ApixabanDRUG
Also known as: Eliquis
Apixaban
RivaroxabanDRUG
Also known as: Xarelto
Rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed newly diagnosed acute VTE (proximal lower extremity deep vein thrombosis and segmental or greater pulmonary embolism)
  • Age ≥ 18 years old
  • Written informed consent

You may not qualify if:

  • Any contraindication for anticoagulation such as active bleeding
  • Clinically significant liver disease or alanine aminotransferase (ALT) levels ≥ 3 times the upper limit of normal range
  • Creatinine clearance \< 30 ml/min calculated with the Cockcroft-Gault formula (29)
  • Known allergies to either apixaban or rivaroxaban
  • Pregnancy
  • Use of contraindicated medications with apixaban or rivaroxaban
  • Active malignancy in the last 6 months (excluding localized skin malignancy)
  • No private insurance coverage for the study drug or not willing to pay for study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Hôtel-Dieu de Sherbrooke

Sherbrooke, Quebec, J1G 2E8, Canada

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

apixabanRivaroxaban

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lana Castellucci, MD, FRCPC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 24, 2015

Study Start

May 1, 2016

Primary Completion

November 1, 2017

Study Completion

February 1, 2018

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)