The goal of this clinical trial, called a pilot study or a feasibility study, is to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. This type of study includes a small number of participants so it is not expected to prove how safe the treatment is or how well the treatment works.
The main question it hopes to answer is:
1.What is the average number of patients that are recruited per month during the 12 month study period?
To test the study plan, adults being treated for a superficial vein thrombosis (SVT), which is a blood clot in the superficial veins of the leg, will be given a type of blood thinner called rivaroxaban. Half of the participants in this study will be given the standard (low-dose) rivaroxaban for 45 days, then 45 days of placebo (a substance that looks like the study medication but does not have any active or medicinal ingredients). The other half of participants will be given full-dose rivaroxaban for a total of 90 days. The placebo in this study is not intended to have any effect on the participants blood clot. A placebo is used to make the results of the study more reliable.
Adult patients age ≥ 18 years old.
Objectively confirmed diagnosis within 14 days of an acute symptomatic SVT of the lower extremities by standardized CUS, where SVT is defined as incompressibility of a venous segment located along the course of a known superficial vein.
Anticoagulation for SVT is warranted per clinicians.
Able and willing to provide written informed consent.
Other indication(s) for therapeutic or prophylactic dose anticoagulation (e.g. atrial fibrillation, mechanical valve, etc.).
History of PE or DVT within 6 months (180 days) of screening.
>5 days of any anticoagulants for the index SVT.
Requires use of aspirin >100mg daily or other antiplatelet agents.
Parallel
Full dose rivaroxaban
DrugThe intervention group will receive full dose rivaroxaban for 90 days.
Low dose rivaroxaban
DrugThe comparator group will receive the standard treatment of low dose rivaroxaban.
Placebo
DrugSince the treatment arm has an AM and PM dose of study drug from Day 1-21, the comparator group will take 1 placebo pill in the PM to keep the two arms blinded.
Primary Feasibility Outcome
The primary feasibility outcome of this pilot trial is the average number of patients recruited per month during the 12 month recruitment period.
Secondary Feasibility Outcomes
The rate (%) of eligible patients that give consent to participate.
Secondary Feasibility Outcomes
The rate (%) of patients that are not lost to follow-up.
Secondary Feasibility Outcomes
The rate (%) of patients who complete and adhere to the study procedures.
Secondary Feasibility Outcomes
Reasons why eligible patients chose not to participate.
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