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Apixaban 2.5 MG Oral Tablet [ELIQUIS] for Essential Thrombocythemia

The Ottawa Hospital, Ottawa, Canada
Essential Thrombocythemia+5 More ConditionsApixaban 2.5 MG Oral Tablet [ELIQUIS] - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new drug, apixaban, to see if it is safe and effective in treating myeloproliferative neoplasms (MPNs), which are blood disorders that occur when the body makes too many white or red blood cells, or platelets.

Eligible Conditions
  • Essential Thrombocythemia
  • Polycythemia Vera
  • Deep Vein Thrombosis (DVT)
  • Myeloproliferative Neoplasms
  • JAK2 V617F Mutation
  • Primary Myelofibrosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

6 Primary · 7 Secondary · Reporting Duration: For the duration of the study follow-up period: 7 months

Month 6
Average monthly subject recruitment rate of all study sites during a 6-month recruitment period
Number of JAK2MPN patients recruited in 6 months in comparison to a target recruitment total of 39 prevalent cases and 5 incident cases at minimum
Percentage of incident and prevalent cases included in the study
Study Feasibility 1: Feasibility of recruitment
Study Feasibility 2: Feasibility of enrollment
Month 7
Quality of life on apixaban and aspirin will be measured through the use of the RAND 36-Item Health Survey (SF-36), with scores being transformed into a 0-100 scale where the higher the score the less disability.
Rate of all-cause mortality
Rate of combined arterial and venous thrombotic events (MI, stroke, transient ischemic attack, peripheral arterial thrombosis, VTE)
Rate of major bleeding as per the International Society of Thrombosis and Hemostasis definitions
Rate of non-major clinically relevant bleeding as per the International Society of Thrombosis and Hemostasis definitions
Study Feasibility 3: Patient retention rate
Study drug compliance as assessed by the proportion of study drug prescribed to the patient versus the actual amount study drug taken by the patient
Study visit compliance as assessed by the number of study visits (in person and/or phone call) completed

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Aspirin and cytoreductive therapy (if applicable)
1 of 2
Apixaban and cytoreductive therapy (if applicable)
1 of 2

Active Control

Experimental Treatment

46 Total Participants · 2 Treatment Groups

Primary Treatment: Apixaban 2.5 MG Oral Tablet [ELIQUIS] · No Placebo Group · Phase 2

Apixaban and cytoreductive therapy (if applicable)
Drug
Experimental Group · 1 Intervention: Apixaban 2.5 MG Oral Tablet [ELIQUIS] · Intervention Types: Drug
Aspirin and cytoreductive therapy (if applicable)
Drug
ActiveComparator Group · 1 Intervention: Aspirin 81 mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: for the duration of the study follow-up period: 7 months

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
544 Previous Clinical Trials
2,517,961 Total Patients Enrolled
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) NetworkNETWORK
8 Previous Clinical Trials
15,984 Total Patients Enrolled
the Association médicale universitaire de l'Hôpital Montfort (AMUHM)UNKNOWN
Canadian Society of HematologyUNKNOWN
Miriam Kimpton, MDPrincipal InvestigatorThe Ottawa Hospital
Aurelien Delluc, MD, PhDPrincipal InvestigatorThe Ottawa Hospital

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The participant is able and willing to comply with study procedures and follow-up examinations contained within the written consent form.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
The Ottawa Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

Approximately how many individuals are engaged in this research?

"Affirmative. Clinical trials' website has published that this medical experiment, which was made public on February 17th 2021, is currently open for enrollment. A total of 46 individuals are desired from a single clinical facility." - Anonymous Online Contributor

Unverified Answer

Has the FDA given authorization to Apixaban 2.5 MG Oral Tablet [ELIQUIS] yet?

"The safety of Apixaban 2.5 MG Oral Tablet [ELIQUIS] has been evaluated as a two on the scale from one to three, given that this is a Phase II trial with some evidence for its security but no data confirming efficacy." - Anonymous Online Contributor

Unverified Answer

Is this an unprecedented clinical trial?

"Since its initial Phase 1 trial in 2005, sponsored by Abbott and involving 15480 patients, Apixaban 2.5 MG Oral Tablet [ELIQUIS] has been studied extensively with 207 active studies in 1452 cities across 62 countries leading to its approval for use as a medication." - Anonymous Online Contributor

Unverified Answer

What purposes does Apixaban 2.5 MG Oral Tablet [ELIQUIS] usually serve?

"Apixaban 2.5 MG Oral Tablet [ELIQUIS] is typically prescribed for deep vein thrombosis, but it may also be effective in mitigating death by myocardial infarction, back pain and after procedures such as percutaneous coronary intervention (PCI)." - Anonymous Online Contributor

Unverified Answer

Is access to this experiment available for prospective participants?

"According to the information posted on clinicaltrials.gov, recruitment for this medical study is still ongoing. The trial was initially created February 17th 2021 and recently modified April 19th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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