A Phase 3 interventional study of Apixaban and Warfarin in Transient Ischemic Attack, Stroke and Atrial Fibrillation, sponsored by University of South Florida. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by University of South Florida · Phase 3, Interventional, and Prevention
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.
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.
329 studies on the registry are indexed under Ischemic Attack, Transient; 71 are open to participants now.
This study's enrollment of 91 is below the median of 217 across 178 interventional studies indexed under Ischemic Attack, Transient.
Browse Ischemic Attack, Transient studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
History of intracranial bleed
a. Traumatic intracranial bleed within one year of randomization. (Traumatic ICH greater than one year of randomization is not an exclusion).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apixaban 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
Drug: Apixaban
standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).
Drug: Warfarin
Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA
Time frame: 180 days
Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT
Time frame: 180 days
| Milestone | Apixaban | Warfarin |
|---|---|---|
| Started | 41 | 47 |
| Received allocated treatment intervention | 38 | 31 |
| Completed | 38 | 39 |
| Not completed | 3 | 8 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 6 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Thrombus on transesophageal echocardiogram | 0 | 1 |
| Participants | Apixaban | Warfarin |
|---|---|---|
| Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA | 7 | 12 |
| Participants | Apixaban | Warfarin |
|---|---|---|
| Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT | 5 | 6 |
Collected over 210 +/- 10 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apixaban | 2/41 (4.9%) | 11/41 (26.8%) | 36/41 (87.8%) |
| Warfarin | 4/47 (8.5%) | 14/47 (29.8%) | 41/47 (87.2%) |
| Event | Apixaban | Warfarin |
|---|---|---|
| Recurrent StrokeGeneral disorders | 5/41 | 7/47 |
| Fatal StrokeGeneral disorders | 1/41 | 3/47 |
| Worsening Congestive Heart FailureCardiac disorders | 2/41 | 0/47 |
| Third Degree AV BlockCardiac disorders | 0/41 | 2/47 |
| Worsening Atrial FibrillationCardiac disorders | 1/41 | 2/47 |
| TIAGeneral disorders | 1/41 | 2/47 |
| PancolitisGastrointestinal disorders | 0/41 | 2/47 |
| Pancreatic CancerEndocrine disorders | 1/41 | 0/47 |
| Symptomatic HypotensionCardiac disorders | 1/41 | 0/47 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 1/41 | 0/47 |
| Event | Apixaban | Warfarin |
|---|---|---|
| Bilateral Lower Extremity EdemaCardiac disorders | 10/41 | 3/47 |
| DizzinessCardiac disorders | 2/41 | 9/47 |
| Supratherapeutic INRCardiac disorders | 0/41 | 9/47 |
| Fall without InjuryMusculoskeletal and connective tissue disorders | 7/41 | 3/47 |
| BruisingSkin and subcutaneous tissue disorders | 1/41 | 8/47 |
| Urinary Tract InfectionRenal and urinary disorders | 6/41 | 3/47 |
| Chest Pain or TightnessCardiac disorders | 6/41 | 3/47 |
| AbrasionsSkin and subcutaneous tissue disorders | 1/41 | 6/47 |
| FatigueCardiac disorders | 5/41 | 5/47 |
| Intermittent HeadachesGeneral disorders | 5/41 | 5/47 |
| Age, Categorical(Participants) | Apixaban | Warfarin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 25 |
| >=65 years | 28 | 35 | 63 |
| Age, Continuous(years) | Apixaban | Warfarin | Total |
|---|---|---|---|
| Mean | 72.6 ± 14.9 | 74.3 ± 10.5 | 73.5 ± 12.7 |
| Sex: Female, Male(Participants) | Apixaban | Warfarin | Total |
|---|---|---|---|
| Female | 26 | 23 | 49 |
| Male | 15 | 24 | 39 |
| Race/Ethnicity, Customized(Participants) | Apixaban | Warfarin | Total |
|---|---|---|---|
| Black | 7 | 5 | 12 |
| Hispanic | 3 | 6 | 9 |
| Non-Hispanic White | 31 | 35 | 66 |
| Other | 0 | 1 | 1 |
| Region of Enrollment(participants) | Apixaban | Warfarin | Total |
|---|---|---|---|
| United States | 41 | 47 | 88 |
| Hypertension(Participants) | Apixaban | Warfarin | Total |
|---|---|---|---|
| Count of participants | 38 | 46 | 84 |
| Hyperlipidemia(Participants) | Apixaban | Warfarin | Total |
|---|---|---|---|
| Count of participants | 24 | 34 | 58 |
| Coronary artery disease (CAD)(Participants) | Apixaban | Warfarin | Total |
|---|---|---|---|
| Count of participants | 13 | 18 | 31 |
29 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2015 to primary completion in Jun 2019, 50 months.
Results were first posted in Nov 2021, 2 years 5 months after primary completion.
Of 13 phase 3 interventional studies under Ischemic Attack, Transient, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 51. This study's 50 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apixaban