RECRUITING

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

Conditions

Stroke Atrial Fibrillation Transient Atrial Fibrillation Perioperative Atrial Fibrillation Non-vitamin K Oral Anticoagulation Noncardiac Surgery PROBE Design

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.

Official Title

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial

Quick Facts

Study Start:2019-06-14

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03968393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. noncardiac surgery in the past 35 days with at least one of the following: 1. an overnight hospital admission after surgery; 2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator 2. ≥1 episode of clinically important perioperative AF during or after their surgery; 3. sinus rhythm at the time of randomization; AND 4. any of the following high-risk criteria: 1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level; 2. 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 3. age ≥75 years. 5. provide written informed consent	1. history of documented chronic AF prior to noncardiac surgery; 2. need for long-term systemic anticoagulation; 3. ongoing need for long-term dual antiplatelet treatment; 4. contraindication to oral anticoagulation; 5. severe renal insufficiency (CrCl \<20 ml/min); 6. severe liver cirrhosis (i.e., Child-Pugh Class C) 7. acute stroke in the past 14 days; 8. underwent cardiac surgery in the past 35 days; 9. history of nontraumatic intracranial, intraocular, or spinal bleeding; 10. hemorrhagic disorder or bleeding diathesis; 11. expected to be non-compliant with follow-up and/or study medications; 12. known life expectancy less than 1 year due to concomitant disease; 13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR 14. previously enrolled in the trial

Inclusion Criteria

Exclusion Criteria

1. noncardiac surgery in the past 35 days with at least one of the following:
1. an overnight hospital admission after surgery;
2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator
2. ≥1 episode of clinically important perioperative AF during or after their surgery;
3. sinus rhythm at the time of randomization; AND
4. any of the following high-risk criteria:
1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
2. 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
3. age ≥75 years.
5. provide written informed consent

1. history of documented chronic AF prior to noncardiac surgery;
2. need for long-term systemic anticoagulation;
3. ongoing need for long-term dual antiplatelet treatment;
4. contraindication to oral anticoagulation;
5. severe renal insufficiency (CrCl \<20 ml/min);
6. severe liver cirrhosis (i.e., Child-Pugh Class C)
7. acute stroke in the past 14 days;
8. underwent cardiac surgery in the past 35 days;
9. history of nontraumatic intracranial, intraocular, or spinal bleeding;
10. hemorrhagic disorder or bleeding diathesis;
11. expected to be non-compliant with follow-up and/or study medications;
12. known life expectancy less than 1 year due to concomitant disease;
13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
14. previously enrolled in the trial

Contacts and Locations

Study Contact

Cassie McDonald

CONTACT

1-905-594-0560

aspireaf@phri.ca

Principal Investigator

David Conen, MD, MPH

PRINCIPAL_INVESTIGATOR

Population Health Research Institute

PJ Devereaux, MD, PhD

STUDY_CHAIR

Population Health Research Institute

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Mcgovern Medical School at University of Texas

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Population Health Research Institute

David Conen, MD, MPH, PRINCIPAL_INVESTIGATOR, Population Health Research Institute
PJ Devereaux, MD, PhD, STUDY_CHAIR, Population Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-14

Study Completion Date2028-12

Study Record Updates

Study Start Date2019-06-14

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

Transient Atrial Fibrillation
Perioperative Atrial Fibrillation
Non-vitamin K Oral Anticoagulation
Noncardiac Surgery
PROBE Design

Additional Relevant MeSH Terms

Stroke
Atrial Fibrillation