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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

Must not have

Diabetes mellitus

Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-year follow-up

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 or younger and had a stroke/TIA treated by closing a hole in my heart.

Exclusion Criteria

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

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I have diabetes.

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I have a blood clotting disorder.

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I am over 60 years old.

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I still have a moderate or larger hole in my heart after surgery.

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I have two or more heart disease risk factors like smoking, high blood pressure, or high cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10-year follow-up

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

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

Primary study objectives

Presence of new ischemic lesions

Presence of new stroke events

Secondary study objectives

Number of ischemic events

Number of new cerebral ischemic lesions

Rate of bleeding

+1 more

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 6Eligibility criteria met