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Clinical Trials/EUCTR2019-001336-62-IT
EUCTR2019-001336-62-IT
Active, not recruiting
Phase 1

Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trial - ASPIRE-AF Trial

Population Health Research Institute0 sites2,800 target enrollmentJanuary 27, 2022
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DrugsELIQUIS - 5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 20 COMPRESSEPradaxaXARELTO - 20 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) 28 COMPRESSELIXIANA - 60 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALLUMINIO) - 28 COMPRESSE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Population Health Research Institute
Enrollment
2800
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients are eligible if they: 1\. underwent noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
  • •2\. have had \=1 episode of clinically important perioperative atrial fibrillation or flutter (AF);
  • •3\. are in sinus rhythm at the time of randomization;
  • •4\. have any of the following high\-risk criteria: a. age 55\-74 years plus either established cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score \=3; or b. age \=75 years;
  • •5\.provide written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 50
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Patients are excluded if they fulfill any of the following criteria: 1\. have a history of documented AF before noncardiac surgery; 2\. need long\-term therapeutic anticoagulation (e.g., mechanical valve); 3\. ongoing need for long\-term dualantiplatelet treatment; 4\. have a contraindication to anticoagulation; 5\. have severe renal insufficiency (i.e., eGFR \<30 ml/min); 6\. have had an acute stroke in the preceding 3 months; 7\. underwent cardiac surgery in the preceding 3 months; 8\.have a history of intracranial, intraocular, or spinal bleeding; 9\. have hemorrhagic disorder or bleeding diathesis; 10\. are expected to be non\-compliant with follow\-up;11\. have a known life expectancy of \<1 year due to concomitant disease; 12\. women who are pregnant, breastfeeding, or of childbearing potential and not taking effective contraception; or 13\. were previously enrolled in the trial

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trial
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