234 Participants NeededMy employer runs this trial

Antithrombotic Management for Atrial Fibrillation

(INTEGRAL Trial)

AM
SM
Overseen BySanghamitra Mohanty, MD MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine the best method for preventing blood clots in individuals with atrial fibrillation (irregular heartbeat) who have received a Watchman device. It compares two treatments: one group will take a long-term half-dose of apixaban (a blood thinner), while the other will take long-term low-dose aspirin. Candidates for this study include those who have had a successful Watchman device implantation without complications and have atrial fibrillation. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have a mandatory need for certain blood thinners or if you are taking prasugrel or ticagrelor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that apixaban, when taken in lower doses, is generally well-tolerated by patients with atrial fibrillation. In earlier studies, patients using apixaban experienced fewer serious bleeding incidents compared to those taking similar drugs, such as rivaroxaban. This suggests that apixaban might carry a lower risk of causing serious bleeding.

Another study found that a lower dose of apixaban is as safe as the full dose. Patients experienced fewer strokes and blood clots without a significant increase in bleeding risks.

While this treatment appears promising, individuals should consider their own health and consult a healthcare provider before making any decisions.12345

Why are researchers excited about this trial's treatments?

Most treatments for atrial fibrillation, such as full-dose anticoagulants like warfarin or full-dose apixaban, work by preventing blood clots but can increase the risk of bleeding. Half-dose apixaban is unique because it aims to reduce the risk of clots with a potentially lower chance of bleeding compared to the standard full doses. Researchers are excited about this treatment as it could offer a safer balance between preventing strokes and minimizing bleeding risks, making it a promising option for long-term management of atrial fibrillation.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation?

Research has shown that apixaban effectively lowers the risk of stroke and blood clots in people with atrial fibrillation. Studies found that apixaban reduces the risk of stroke by 21% and decreases major bleeding by 31% compared to warfarin, another common treatment. In this trial, participants will receive either long-term half-dose apixaban or long-term low-dose aspirin. In everyday use, patients taking apixaban experienced fewer strokes and blood clots than those using other blood thinners like rivaroxaban. These findings suggest that apixaban is a reliable choice for managing blood clot risks in atrial fibrillation.24678

Who Is on the Research Team?

AN

Andrea Natale, MD

Principal Investigator

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Are You a Good Fit for This Trial?

This trial is for people with atrial fibrillation who have had a left atrial appendage occlusion (LAAO) procedure. Participants should be at high risk of stroke but also have a higher risk of bleeding, making long-term full-dose blood thinners unsuitable.

Inclusion Criteria

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
I am 18 years old or older.
I have had or am scheduled for a Watchman device procedure without complications.
See 1 more

Exclusion Criteria

Any contra-indication or known allergy to aspirin or clopidogrel or apixaban
Participating in an investigational drug or another device trial within the previous 30 days
High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either long-term half-dose apixaban or long-term aspirin after 45 days of full-dose apixaban following Watchman implantation

3 years
Outpatient follow-up at 3, 6, 9, 12 months and every 6 months thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment, including TEE imaging to assess device stability and thrombus formation

9 months minimum
TEE imaging at 2-3 and 6-9 months

What Are the Treatments Tested in This Trial?

Interventions

  • Half-Dose Apixaban
  • Low-dose Aspirin

Trial Overview

The study compares two treatments after LAAO: one group takes half the usual dose of apixaban (a blood thinner), and the other takes low-dose aspirin. Both groups start with full-dose apixaban for 45 days before switching to their assigned treatment.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: long-term aspirin (Group ASA)Active Control1 Intervention
Group II: long-term half-dose apixaban (Group hdNOAC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Cardiac Arrhythmia Research Foundation

Lead Sponsor

Trials
40
Recruited
15,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28614582/

Effectiveness and Safety of Standard-Dose Nonvitamin K ...

In this Danish cohort study of patients with atrial fibrillation and a single stroke risk factor, there was no difference between NOACs ...

Apixaban outcomes in atrial fibrillation patients with a ...

The primary effectiveness outcome was stroke/systemic embolism (SSE), and the primary safety outcome was major bleeding. Of 1944 patients (mean age 74.3 ± 7.9 ...

Bristol-Myers Squibb and Pfizer Present Observational ...

Among non-valvular atrial fibrillation (NVAF) patients, Eliquis® (apixaban) was associated with a lower risk of stroke/SE and lower rates of ...

Efficacy and Safety of Apixaban Compared With Warfarin at ...

The overall results showed that apixaban reduced stroke by 21%, death by 11%, and major bleeding by 31%. Key additional questions involved the ...

Effectiveness and Safety of Apixaban Compared With ...

Conclusion: In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34115024/

Off-label reduced-dose apixaban does not ...

Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation: A retrospective, ...

Safety and effectiveness of reduced-dose apixaban in ...

Using a data set from the STANDARD study, we examined the safety and effective- ness of reduced-dose apixaban (2.5 mg BID). In addition, the.

Abstract 245 : Circulation: Cardiovascular Quality and ...

Indirect Comparison of Efficacy and Safety data in Atrial Fibrillation patients treated with Apixaban (Aristotle study) versus Dabigatran (Rely study) based on ...