EUCTR2019-001336-62-NL
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
ConditionsPerioperative atrial fibrillation after noncardiac surgeryMedDRA version: 22.1Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 100000004852MedDRA version: 20.0Level: LLTClassification code 10005103Term: BleedingSystem Organ Class: 100000004866MedDRA version: 20.0Level: LLTClassification code 10003663Term: Atrial flutter/ fibrillationSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Perioperative atrial fibrillation after noncardiac surgery
- Sponsor
- Population Health Research Institute
- Enrollment
- 2800
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients are eligible if they fulfill all of the following criteria:
- •1\. have had noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
- •2\. have had \= one episode of clinically important perioperative AF during or after their surgery;
- •3\. are in sinus rhythm at the time of randomization;
- •4\. meet any of the following high\-risk criteria; and
- •o age 55\-74 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score \= 3; or
- •o age \= 75 years.
- •5\. provide written informed consent to participate
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Patients are excluded if they meet any of the following criteria:
- •1\. have a history of documented AF prior to noncardiac surgery; a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices) or a previous history of perioperative AF only (after cardiac or noncardiac surgery) are not exclusion criteria;
- •2\. need for long\-term systemic anticoagulation (e.g., pre\-existing AF, mechanical heart valve);
- •3\. have an ongoing need for long\-term dual antiplatelet treatment;
- •4\. have a contraindication to oral anticoagulation;
- •5\. have severe renal insufficiency (eGFR \< 30 ml/min);
- •6\. have had an acute stroke in the past three months;
- •6\. have had cardiac surgery in the past three months;
- •7\. have a history of nontraumatic intracranial, intraocular, or spinal bleeding;
- •8\. have hemorrhagic disorder or bleeding diathesis;
Outcomes
Primary Outcomes
Not specified
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Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trialEUCTR2019-001336-62-DKHamilton Health Sciences Corporation2,800
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