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Antiplatelet Agent

Genetic Testing for Stroke Treatment (NUANCE-ICAD Trial)

N/A

Waitlist Available

Led By Mark I Boulos, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

Clinical indication for DAPT for at least 3 months

Age ≥ 40 years old, male and female

Must not have

Any contraindication to DAPT

Any contraindication to use of clopidogrel (Plavix) or ticagrelor (Brilinta), such as pregnancy. A pregnancy test will be performed on all women of child-bearing age prior to enrollment in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90 ± 14

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if genetic testing can help choose the right medication for stroke patients. Some people may not benefit from Clopidogrel due to genetic differences, so Ticagrelor may be a

Who is the study for?

This trial is for adults who've had a stroke due to plaque build-up in brain arteries (ICAD). Participants must be willing to undergo genetic testing or take standard medication, Clopidogrel, for 90 days. Specific eligibility criteria are not provided but typically include factors like age, medical history, and the ability to comply with study requirements.

What is being tested?

The trial tests if using genetic testing to choose between two blood-thinning medications—Ticagrelor or Clopidogrel—can prevent further strokes in ICAD patients. One group gets standard care with Clopidogrel; the other gets Ticagrelor based on their gene test results.

What are the potential side effects?

Potential side effects of Ticagrelor and Clopidogrel may include bleeding risks, shortness of breath, headache, dizziness, nausea or allergic reactions. The severity can vary from mild discomfort to more serious complications.

Eligibility Criteria

Inclusion Criteria

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

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I need dual antiplatelet therapy for at least 3 months.

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I am 40 years old or older.

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I had a stroke or mini-stroke due to narrowed arteries in my brain.

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I had a stroke or mini-stroke in the last 30 days.

Exclusion Criteria

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

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I cannot take dual antiplatelet therapy.

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I cannot take clopidogrel or ticagrelor due to reasons like pregnancy.

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I have a blood clot inside a blood vessel.

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I have a complete blockage in an artery in my brain causing a stroke.

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I have had a bleeding in my brain that cannot be treated with a procedure, within the last year.

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I live in a nursing home or need daily help with personal care.

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I have a brain tumor (not meningioma) or a brain blood vessel abnormality.

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My brain artery narrowing is not due to hardening of the arteries.

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I have a blockage in the neck artery on the same side as my brain ischemia and am planning surgery to fix it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90 ± 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 90 ± 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 ± 14 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients with Symptomatic intracerebral hemorrhage (ICH)

Proportion of patients with major extracranial bleeding

Proportion of patients with non-bleeding adverse events

+3 more

Secondary study objectives

Change in Montreal Cognitive Assessment (MoCA) score from baseline to follow-up

Change in NIH Stroke Scale (NIHSS) score from baseline to follow-up

Change or shift in modified Rankin Scale (mRS) score from baseline to follow-up

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Point-of-Care CYP2C19 TestingExperimental Treatment3 Interventions

Patients will undergo point-of-care CYP2C19 testing with the Research Use Only (RUO) Genomadix Cube to inform the choice of P2Y12 inhibitor (i.e. clopidogrel vs ticagrelor).

Group II: Standard of CareActive Control1 Intervention

Patients will receive standard-of-care ASA + clopidogrel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

clopidogrel + aspirin

2008

N/A

~20

0 / 13Eligibility criteria met