← Back to Search

Antiplatelet Treatment Discontinuation After PFO Closure for Stroke (HALTI Trial)

N/A
Recruiting
Research Sponsored by Josep Rodes-Cabau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-year follow-up
Awards & highlights

HALTI Trial Summary

This trial looks at whether it's safe to stop taking blood-thinners after having a transcatheter PFO closure, 12 months after the procedure.

Who is the study for?
This trial is for individuals under 60 who've had a cryptogenic stroke or TIA and successfully underwent transcatheter PFO closure. It's not for those over 60, with MRI contraindications, high RoPE score, significant residual shunt post-closure, atrial fibrillation after closure, multiple cardiovascular risk factors including smoking and hypertension, diabetes, thrombophilia or recurrent strokes/TIAs within a year of closure.Check my eligibility
What is being tested?
The study tests the safety of stopping antiplatelet treatment one year after successful PFO (a hole in the heart) closure in young patients who have had an unexplained stroke. The goal is to see if it's safe to discontinue blood-thinning medications that prevent clotting after this procedure.See study design
What are the potential side effects?
While specific side effects are not listed for discontinuing antiplatelet therapy post-PFO closure, potential risks may include increased chances of clot formation leading to stroke due to reduced blood thinning from medication cessation.

HALTI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 60 or younger and had a stroke/TIA treated by closing a hole in my heart.

HALTI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Presence of new ischemic lesions
Presence of new stroke events
Secondary outcome measures
Number of ischemic events
Number of new cerebral ischemic lesions
Rate of bleeding
+1 more

HALTI Trial Design

1Treatment groups
Experimental Treatment
Group I: Antiplatelet treatment discontinuationExperimental Treatment1 Intervention
At 12 months post-PFO closure, patients will discontinue the antiplatelet treatment. All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.

Find a Location

Who is running the clinical trial?

Josep Rodes-CabauLead Sponsor
3 Previous Clinical Trials
1,314 Total Patients Enrolled
1 Trials studying Ischemic Stroke
714 Patients Enrolled for Ischemic Stroke

Media Library

Antiplatelet treatment discontinuation Clinical Trial Eligibility Overview. Trial Name: NCT04475510 — N/A
Ischemic Stroke Research Study Groups: Antiplatelet treatment discontinuation
Ischemic Stroke Clinical Trial 2023: Antiplatelet treatment discontinuation Highlights & Side Effects. Trial Name: NCT04475510 — N/A
Antiplatelet treatment discontinuation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04475510 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criterion for this experiment encompass individuals over 30?

"This study is recruiting individuals who are of legal age and younger than 60 years old."

Answered by AI

Is this trial open to recruitment at the moment?

"Clinicaltrials.gov has confirmed that this clinical trial is still seeking participants, with the first post made on July 8th 2020 and most recent update on September 21st 2021."

Answered by AI

What are the stated objectives of this research project?

"This clinical trial, monitored for a period of two years, is designed to assess stroke events. Secondary aims are the number and volume of cerebral ischemic lesions evaluated through MRI as well as the total count of strokes and transient ischemia attacks (TIAs)."

Answered by AI

To what population is this trial open?

"100 prospective patients are qualified to join this trial, provided they have suffered from a wake-up stroke and fall within the age parameter of 18 - 60 years old."

Answered by AI

What is the current number of participants for this clinical research?

"Affirmative. According to clinicaltrials.gov, this medical research project is still recruiting participants from one location and requires 100 volunteers. The trial was first published on July 8th 2020 with the most recent edits being done on September 21st 2021."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Josep Rodes-Cabau 2020. "Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04475510.
~2 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top