BridgeMD
Prevention study 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)?
Non-vitamin K oral anticoagulant (NOAC) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for stroke.
Also referred to as Apixaban, Dabigatran.
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
- Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
- 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
- have ≥1 episode of clinically important AFOTS during any of the following conditions:
- 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;
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
- have ≥1 episode of clinically important AFOTS during any of the following conditions:
- 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;
- any of the following high-risk criteria:
- 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's taking place
- 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
- Santa Fe, Argentina
- Garran, Australian Capital Territory, Australia
- Bankstown, New South Wales, Australia
- Camperdown, New South Wales, Australia
- Concord, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Newcastle, New South Wales, Australia
- Westmead, New South Wales, Australia
- Birtinya, Queensland, Australia
- Herston, Queensland, Australia
- Redcliffe, Queensland, Australia
- Adelaide, South Australia, Australia
- Box Hill, Victoria, Australia
+ 75 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include 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 89 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.