What is the mechanism of action of this treatment?

Oral anticoagulants, such as warfarin and direct oral anticoagulants (DOACs) like rivaroxaban and apixaban, work by inhibiting specific factors in the blood coagulation cascade, thereby preventing the formation of blood clots. Warfarin inhibits vitamin K-dependent clotting factors, while DOACs directly inhibit either thrombin or factor Xa. This is crucial for stroke patients, especially those with atrial fibrillation, as it reduces the risk of stroke by preventing the formation of clots that can travel to the brain and cause ischemic events. Effective anticoagulation therapy can significantly lower the incidence of stroke and other adverse cardiovascular events in these high-risk patients.

What side effects are associated with this type of intervention?

Oral anticoagulants, such as warfarin, rivaroxaban, and apixaban, are commonly used to prevent stroke by inhibiting blood clot formation. The primary side effect of these medications is an increased risk of bleeding, which can range from minor bruising to severe hemorrhages, including gastrointestinal bleeding and intracranial hemorrhage. Other potential side effects include gastrointestinal discomfort, liver enzyme abnormalities, and, in rare cases, allergic reactions. Regular monitoring and dose adjustments are often required to minimize these risks.

What prior FDA approvals exist?

The FDA has approved several oral anticoagulants for the prevention and treatment of stroke, particularly in patients with atrial fibrillation. These include warfarin, which has been a long-standing treatment, and newer agents such as dabigatran, rivaroxaban, apixaban, and edoxaban. These drugs work by inhibiting various factors in the blood clotting process, thereby reducing the risk of stroke. The approval of these medications has provided more options for patients and clinicians in managing stroke risk, especially in those with non-valvular atrial fibrillation.

What other types of research exist?

Promising novel alternatives to oral anticoagulation for stroke patients include: 1) Direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, and apixaban, which have shown efficacy in various trials. 2) Antiplatelet therapy with agents such as clopidogrel or ticagrelor, especially in combination with aspirin, has been effective in preventing recurrent strokes. 3) Catheter-directed thrombolysis and mechanical thrombectomy are emerging as effective interventions for acute stroke management. 4) Newer anticoagulants and antithrombotic agents under investigation may offer additional options in the near future.

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Anticoagulant

Blood Thinners for Atrial Fibrillation (ASPIRE-AF Trial)

Phase 4

Recruiting

Led By David Conen, MD, MPH

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days

≥1 episode of clinically important perioperative AF during or after their surgery

Must not have

Hemorrhagic disorder or bleeding diathesis

Severe renal insufficiency (eGFR <30 ml/min)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether taking blood-thinning pills can prevent strokes and other heart issues in patients who have temporary irregular heartbeats and are at risk of stroke after surgery. These pills are a recent breakthrough in preventing strokes.

Who is the study for?

This trial is for people aged 55-74 with cardiovascular disease, recent major vascular surgery, or a high stroke risk score; or those over 75. Participants must have had noncardiac surgery within the last 35 days and experienced at least one episode of atrial fibrillation afterward. It's not for individuals who need long-term antiplatelet treatment, have contraindications to oral anticoagulants, severe kidney issues, bleeding disorders, are pregnant without contraception use, or have a life expectancy under one year.

What is being tested?

The study tests if taking a Non-vitamin K oral anticoagulant (NOAC) can prevent strokes and other heart problems in patients who've had temporary atrial fibrillation after non-heart-related surgery compared to no blood thinning treatment.

What are the potential side effects?

Possible side effects of NOACs include bleeding complications such as gastrointestinal bleeds or more rarely brain hemorrhages. They may also cause anemia and potentially affect liver enzymes. Kidney function needs monitoring since NOACs are cleared by the kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery (not heart surgery) and stayed in the hospital overnight within the last 35 days.

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I have had at least one significant episode of AFib during or after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder.

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My kidney function is severely reduced.

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I had heart surgery within the last 3 months.

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I need medication to prevent blood clots long-term.

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I need to continue taking two types of medication to prevent blood clots.

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I cannot take blood thinners in pill form due to health reasons.

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I have had a stroke in the last 3 months.

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I have had bleeding in my brain, eyes, or spine without injury.

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I have had atrial fibrillation before any non-heart surgery.

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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective contraception.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Hospitalization for all causes

Hospitalization for vascular causes

Incidence of composite of life-threatening, major, and critical organ bleeding

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-vitamin K oral anticoagulant (NOAC)Experimental Treatment1 Intervention

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.

Group II: No anticoagulationActive Control1 Intervention

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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oral anticoagulants, such as warfarin and direct oral anticoagulants (DOACs) like rivaroxaban and apixaban, work by inhibiting specific factors in the blood coagulation cascade, thereby preventing the formation of blood clots. Warfarin inhibits vitamin K-dependent clotting factors, while DOACs directly inhibit either thrombin or factor Xa. This is crucial for stroke patients, especially those with atrial fibrillation, as it reduces the risk of stroke by preventing the formation of clots that can travel to the brain and cause ischemic events. Effective anticoagulation therapy can significantly lower the incidence of stroke and other adverse cardiovascular events in these high-risk patients.