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Taking people in ItalyPhase 4

Blood Thinner Study for Stroke Prevention in Brief Atrial Fibrillation Linked to Stress

Tests a blood thinner in adults over 55 with atrial fibrillation triggered by stress.

Key facts

Who runs it
Population Health Research Institute
Where
Alessandria, Empoli, Milan, Palermo, Piacenza, and Rozzano, ItalySee the 7 sitesAlso in 20 other countries, 124 sites
Registry title
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress
Status
Recruiting
Phase
Phase 4
People taking part
2,270 people, planned
Started
14 Jun 2019
Expected to end
Dec 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Non-vitamin K oral anticoagulant (NOAC)
Record updated
12 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 55 or older who had a brief episode of atrial fibrillation during a stress such as surgery or a serious illness, and who have extra stroke risk.

Age
55 years or older, with extra risk criteria that depend on the age group (55-64, 65-74, 75 or older).
Sex
All sexes can join.
Disease stage
At least 1 episode of atrial fibrillation during non-heart surgery or an acute illness needing hospital admission in the past 35 days. Heart rhythm must be normal (sinus rhythm) at randomization.
Earlier treatment
People who need long-term blood thinners or long-term dual antiplatelet treatment cannot join. People who had heart surgery in the past 35 days cannot join.
Biomarker or test result
For ages 55-74, one way to qualify is an elevated troponin level after surgery. CHA2DS2VASc score of 3 or more (ages 55-64) or 2 or more (ages 65-74) is another way.

Main reasons for not taking part

  • A heart problem was the main reason for hospital admission
  • Known long-term atrial fibrillation before the surgery
  • Cannot take oral blood thinners, or has a bleeding disorder or past bleeding in the brain, eye or spine
  • Severe kidney problems (CrCl <20 ml/min) or severe liver cirrhosis (Child-Pugh Class C)
  • Acute stroke in the past 14 days

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • history of documented chronic AF prior to noncardiac surgery
  • expected to be non-compliant with follow-up and/or study medications
  • known life expectancy less than 1 year due to concomitant disease
  • previously enrolled in the trial
  • any cardiac diagnosis as the primary reason for hospital admission
  • severe renal insufficiency (CrCl <20 ml/min)
  • 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
  • need for long-term systemic anticoagulation
  • ongoing need for long-term dual antiplatelet treatment
  • contraindication to oral anticoagulation
  • severe liver cirrhosis (i.e., Child-Pugh Class C)
  • women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR

Where in Italy

Also in 20 other countries, 124 sites

  • A.O.SS Antonio Biagio e Cesare Arrigo AlessandriaAlessandria, ItalyTaking people
  • SOC Medicina Interna I – Azienda USL Toscana CentroEmpoli, ItalyTaking people
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • La Maddalena S.p.A.Palermo, ItalyTaking people
  • Azienda Unita Sanitaria Locale Di PiacenzaPiacenza, ItalyTaking people
  • IRCCS Humanitas Research HospitalRozzano, ItalyTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Non-vitamin K oral anticoagulant (NOAC)Treatment being tested

    Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.

  • No anticoagulationNo study treatment, for comparison

    Participants randomized to the control arm will not be prescribed an oral anticoagulant unless they develop a clear indication for one during follow-up (e.g., recurrent nonoperative AF). They can be newly prescribed or continue taking low dose aspirin or another single antiplatelet agent as per the protocol. This will be decided by the participant's physician.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial
Plain-language title
Blood Thinner Study for Stroke Prevention in Brief Atrial Fibrillation Linked to StressGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 January 2026