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Transient Ischemic AttackPhase 3ARESTNCT02283294

Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation

A Phase 3 study testing Apixaban and Warfarin in people with Transient Ischemic Attack and Stroke, run by University of South Florida at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate if Apixaban will decrease the complication of having another stroke for people who have atrial fibrillation if initiated earlier than standard of care. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apixaban and Warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
5 sitesUnited States
Study dates
Apr 2015to Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Written Informed Consent
  • Males and Females over 18 years of age.
  • History of Nonvalvular Atrial Fibrillation (NVAF) by documentation in the medical history or newly diagnosed nonvalvular Atrial Fibrillation at time of study randomization by ECG, device or telemetry .
  • Diagnosis of TIA or small or medium ischemic stroke 0 to 48 hours from signs or symptoms.
  • Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study and within 24 hours of study treatment initiation.
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug Apixaban plus 5 half-lives (approximately 3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion.
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  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with Apixaban plus 5 half-lives (approximately 3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion.
  • 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.
  • 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.
  • Complete Abstinence

Who cannot join

  • Hemorrhagic stroke
  • Large ischemic stroke
  • History of major bleeding within the last 6 months from time of subject enrollment (e.g. GI bleed).
  • History of intracranial bleed
  • Traumatic intracranial bleed within one year of randomization. (Traumatic ICH greater than one year of randomization is not an exclusion).
  • Current or history of bleeding disorders (e.g. blood dycrasias)
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  • Blood Pressure of 180/100 mmHg on hypertensive therapy day of randomization per PI discretion 20.
  • Current illicit drug use and/or chronic alcohol use per PI discretion.
  • Severe liver disease (AST/ALT 2x upper limit).
  • Patients with kidney disease meeting criteria to take 2.5 mg twice daily who are taking strong dual inhibitors of CYP3A4 and P-glycoprotein (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) .
  • Any other suspected etiology for stroke (e.g. ipsilateral carotid disease).
  • Greater than 3 Cerebral Micro-bleeds (CMB) on gradient recovery echo (GRE) or evidence of intracranial hemorrhage on CT at time of randomization. (SWI sequencing may be used if GRE sequencing is not obtainable)
  • Therapeutically anti-coagulated at time of admission (INR at admission greater than 2.0 on warfarin or took two consecutive doses of NOAC).
  • Absolute indication for use of warfarin only.( e.g. Mechanical Valve)
  • Absolute indication for anticoagulation prior to randomization window. (e.g. DVT)
  • Hemoglobin less than 9 gm/dl and/or platelet count less than 100 K/uL.
  • Requires dual antiplatelet therapy.
  • Daily use of NSAIDS
  • Pregnancy or lactation.
  • Any use of an investigational product within the past 30 days.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  • Concurrent participation in another clinical study where use of an investigational product is used

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Louisville

    Louisville, Kentucky, 40202

  • Bayfront Health St Petersburg

    St. Petersburg, Florida, 33701

  • Tampa General Hospital

    Tampa, Florida, 33602

  • University of South Florida

    Tampa, Florida, 33602

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

About this study

The purpose of this study is to evaluate if Apixaban will decrease the complication of having another stroke for people who have atrial fibrillation if initiated earlier than standard of care.

Read the detailed description

This is an Open label, randomized, active control, parallel-group pilot trial to examine the effect of initiation of APIXABAN at days 0-3 (TIA), days 3-5 (small stroke) and days 7-9 (medium stroke) to decrease fatal and/or recurrent stroke/TIA in 120 subjects who have suffered a recent( 0 to 48 hours from symptoms) TIA, or small to medium ischemic stroke compared to standard of care warfarin treatment regimen. Subjects will be randomly assigned in a 1:1 ratio to one of two treatment arms (apixaban or warfarin). Subjects will be followed for a total of 180 days during from screening through monthly follow-up visits.

Being tested
Apixaban, Warfarin
Medical subject headings
Ischemic Attack, Transient, Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02283294
Study groupRoleWhat they receive
ApixabanExperimentalApixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively
Receives: Drug: Apixaban
WarfarinActive comparatorstandard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).
Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA

    Measured: 180 days

Secondary outcomes (1)

  1. Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionJun 2019
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283294
Sponsor's protocol ID
PRO00019754
Acronym
AREST
Status last verified
Dec 2018
First submitted
29 Oct 2014
Last updated
30 Nov 2021
Data monitoring committee
Yes

Publications

  • Alrohimi A, Rose DZ, Burgin WS, Renati S, Hilker NC, Deng W, Oliveira GH, Beckie TM, Labovitz AJ, Fradley MG, Tran N, Gioia LC, Kate M, Ng K, Dowlatshahi D, Field TS, Coutts SB, Siddiqui M, Hill MD, Miller J, Jickling G, Shuaib A, Buck B, Sharma M, Butcher KS. Risk of hemorrhagic transformation with early use of direct oral anticoagulants after acute ischemic stroke: A pooled analysis of prospective studies and randomized trials. Int J Stroke. 2023 Aug;18(7):864-872. doi: 10.1177/17474930231164891. Epub 2023 Mar 26.

    PubMed 36907985

  • Labovitz AJ, Rose DZ, Fradley MG, Meriwether JN, Renati S, Martin R, Kasprowicz T, Murtagh R, Kip K, Beckie TM, Stoddard M, Bozeman AC, McTigue T, Kirby B, Tran N, Burgin WS; AREST Investigators. Early Apixaban Use Following Stroke in Patients With Atrial Fibrillation: Results of the AREST Trial. Stroke. 2021 Apr;52(4):1164-1171. doi: 10.1161/STROKEAHA.120.030042. Epub 2021 Feb 25.

    PubMed 33626904

  • Rose DZ, Meriwether JN, Fradley MG, Renati S, Martin RC, Kasprowicz T, Patel A, Mokin M, Murtagh R, Kip K, Bozeman AC, McTigue T, Hilker N, Kirby B, Wick N, Tran N, Burgin WS, Labovitz AJ. Protocol for AREST: Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation-A Randomized Controlled Trial of Early Anticoagulation After Acute Ischemic Stroke in Atrial Fibrillation. Front Neurol. 2019 Sep 20;10:975. doi: 10.3389/fneur.2019.00975. eCollection 2019.

    PubMed 31620067

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban and Warfarin in people with Transient Ischemic Attack and Stroke, run by University of South Florida at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283294, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

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