Recruiting NCT03968393

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

Phase IV Interventional Stroke Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Non-vitamin K oral anticoagulant (NOAC).
Who it may be relevant to: Registry conditions: Stroke, Atrial Fibrillation. Basic parameters: from 55 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Canada +13
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress - The ASPIRE-AF Trial

Overview

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.

Detailed description

ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient atrial fibrillation and additional stroke factors occurring transiently with stress. The primary objective is to assess the effects of NOACs versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Interventions

Drug Non-vitamin K oral anticoagulant (NOAC)
Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.

Primary outcome measures

Incidence of Non-hemorrhagic stroke or systemic embolism [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]

Secondary outcome measures (8)

Incidence of vascular mortality [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of non-fatal, non-hemorrhagic stroke [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of Myocardial infarction [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of peripheral arterial thrombosis [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of amputation [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of symptomatic venous thromboembolism [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of all-cause stroke [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]
Incidence of all-cause mortality [Time frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)]

Eligibility criteria

Inclusion 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Prevention

Study locations

Canada · 24 centers

Foothills Hospital — Calgary
University of Alberta Hospital — Edmonton
Medicine Hat Regional Hospital — Medicine Hat
East Kootenay Regional Hospital — Cranbrook
Fraser Health Authority — Surrey
Vancouver General Hospital — Vancouver
Health Sciences Centre Winnipeg — Winnipeg
Dr.-Georges-L.-Dumont University Hospital Centre — Moncton
… and 16 more centers

Australia · 14 centers

Canberra Hospital — Garran
Bankstown Hospital — Bankstown
Royal Prince Alfred Hospital — Camperdown
Concord Repatriation General Hospital — Concord
Liverpool Hospital — Liverpool
John Hunter Hospital — Newcastle
Westmead Hospital — Westmead
Sunshine Coast Hospital and Health Service — Birtinya
… and 6 more centers

Netherlands · 12 centers

Jeroen Bosch Hospital — 's-Hertogenbosch
Noordwest Ziekenhuisgroep — Alkmaar
ZiekenhuisGroepTwente (ZGT) — Almelo
Ziekenhuis Amstelland — Amstelveen
Rijnstate Hospital — Arnhem
Amphia Ziekenhuis Breda — Breda
Deventer Ziekenhuis — Deventer
Hospital Gelderse Vallei — Ede
… and 4 more centers

India · 10 centers

GNRC Medical — North Guwāhāti
Marengo CIMS Hospital — Ahmedabad
NU Hospitals — Bangalore
Govt. T.D. Medical College — Alappuzha
Amala Institute of Medical Sciences — Thrissur
Amala Institute — Thrissur
St. John's Medical College Hospital — Bangalore
JIPMER — Puducherry
… and 2 more centers

Argentina · 7 centers

Clinica Coronel Suarez — Coronel Suárez
Instituto de Investigaciones Clinicas Rosario — Rosario
Instituto Cardiovascular de Rosario — Rosario
Centro Integral de Arritmias de Tucuman (CIAT) — San Miguel de Tucumán
Hospital Municipal Chivilcoy — Chivilcoy
Sanatorio Cisma — San Miguel de Tucumán
Hospital Privado de Rosario — Santa Fe

Spain · 6 centers