Prevention trial for Stroke
Official title Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
ClinicalTrials.gov ID: NCT03968393
What this study is testing
What is Non-vitamin K oral anticoagulant (NOAC)?
An investigational oral medicine being studied to prevent stroke and other cardiovascular events in people with transient atrial fibrillation. It is designed to block clotting factors (factor Xa or thrombin) to reduce the formation of blood clots.
Also referred to as Apixaban, Dabigatran, Edoxaban, Rivaroxaban.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether an oral blood‑thinner can prevent stroke in people who have brief, stress‑related episodes of irregular heart rhythm and other stroke risk factors.
- Who it's for
- You may be able to join if you have short episodes of atrial fibrillation that happen with stress and have other stroke risk factors.
- What's involved
- You might take a daily oral blood‑thinner or not take it. You will have check‑ups and simple tests to see if a stroke occurs.
- Time commitment
- The study lasts about a year with several visits at the start, middle, and end.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
- noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
- acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause...
- sinus rhythm at the time of randomization;
- age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative...
You likely can't join if
- any cardiac diagnosis as the primary reason for hospital admission;
- history of documented chronic AF prior to noncardiac surgery;
- need for long-term systemic anticoagulation;
- ongoing need for long-term dual antiplatelet treatment;
- contraindication to oral anticoagulation;
- severe renal insufficiency (CrCl \<20 ml/min);
See the full eligibility criteria
- noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
- noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
- acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator;
- sinus rhythm at the time of randomization;
- age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
- age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
- age ≥75 years.;
- provide written informed consent
- any cardiac diagnosis as the primary reason for hospital admission;
- history of documented chronic AF prior to noncardiac surgery;
- need for long-term systemic anticoagulation;
- ongoing need for long-term dual antiplatelet treatment;
- contraindication to oral anticoagulation;
- severe renal insufficiency (CrCl \<20 ml/min);
- severe liver cirrhosis (i.e., Child-Pugh Class C)
- acute stroke in the past 14 days;
- underwent cardiac surgery in the past 35 days;
- history of nontraumatic intracranial, intraocular, or spinal bleeding;
- hemorrhagic disorder or bleeding diathesis;
- expected to be non-compliant with follow-up and/or study medications;
- known life expectancy less than 1 year due to concomitant disease;
- women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
- previously enrolled in the trial
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Houston, Texas, United States
- Coronel Suárez, Buenos Aires, Argentina
- Rosario, Santa Fe Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Chivilcoy, Argentina
- San Miguel de Tucumán, Argentina
- Garran, Australian Capital Territory, Australia
- Bankstown, New South Wales, Australia
- Camperdown, New South Wales, Australia
- Concord, New South Wales, Australia
- Newcastle, New South Wales, Australia
- Westmead, New South Wales, Australia
- Birtinya, Queensland, Australia
- Redcliffe, Queensland, Australia
- Box Hill, Victoria, Australia
- Wangaratta, Victoria, Australia
- Perth, Western Australia, Australia
- Cerqueira César, Brazil
- Porto Alegre, Brazil
+ 62 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Houston, Texas, United States; Coronel Suárez, Buenos Aires, Argentina; Rosario, Santa Fe Province, Argentina; San Miguel de Tucumán, Tucumán Province, Argentina; Chivilcoy, Argentina and 76 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.