Personalized Anti-Platelet Therapy for Hemorrhage

(RAPID PREVENT Trial)

PM
Overseen ByPoppy MacPhee, RN
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Ottawa Heart Institute Research Corporation
Must be taking: Antiplatelets
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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?

This trial explores whether a personalized approach to anti-platelet therapy can reduce bleeding compared to standard treatment. A genotyping test, which checks for a specific gene, determines the best anti-platelet medication for each participant. The trial includes two groups: one receives standard care, while the other receives treatment based on genetic test results (genotyping-guided therapy for anti-platelet management). Individuals who have undergone PCI with stenting and can take ticagrelor or clopidogrel are suitable candidates for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, with research helping to understand how it benefits more patients.

What is the safety track record for genotyping guided therapy for anti-platelet management?

Previous studies have shown that using genetic testing to guide anti-platelet treatment is safe. One study found that patients using this personalized approach experienced fewer bleeding incidents compared to those on standard treatment, specifically reducing the risk of bleeding by about 22%. This suggests the treatment is well-tolerated and may lower the chance of bleeding.

These findings are encouraging because they indicate this personalized approach might be safer for patients. It's important to note that these results come from real patients who have already tried this treatment, providing a good indication of how it might work for others.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about genotyping guided therapy for anti-platelet management because it offers a personalized approach to treating hemorrhage. Unlike the standard of care, which typically involves a one-size-fits-all anti-platelet medication, this method uses a point-of-care genotyping test to identify the presence of the CYP2C19 gene. This allows for tailoring the anti-platelet therapy to the individual's genetic profile, potentially improving effectiveness and reducing the risk of adverse effects. This personalized strategy could lead to more precise and safer treatment outcomes for patients.

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

Research has shown that genetic testing can guide anti-platelet therapy to improve health outcomes. In this trial, participants in the personalized therapy arm will undergo CYP2C19 genotyping to tailor their anti-platelet treatment. Studies indicate that patients with certain genetic differences benefit from this personalized approach, as it helps doctors choose the right medication and dosage. This method has been linked to a lower risk of heart attacks and strokes for some people. Evidence also suggests that this tailored strategy can reduce bleeding risks compared to standard treatments. Overall, genetic testing aids doctors in making more precise treatment decisions for patients needing anti-platelet therapy.12678

Who Is on the Research Team?

DS

Derek So, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for people who need anti-platelet therapy, such as those at risk of blood clots or bleeding after procedures like stent placement. Specific inclusion and exclusion criteria are not listed, so eligibility may depend on individual health status.

Inclusion Criteria

I am older than 18 years.
I am currently receiving PCI with a stent.

Exclusion Criteria

I cannot take clopidogrel.
Not expected to survive >48 hours
I am unable to provide a cheek swab sample.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participants are randomized to either standard of care or personalized therapy with CYP2C19 genotyping and receive the respective anti-platelet therapy

12 months

Follow-up

Participants are monitored for bleeding events and MACCE events, including cardiovascular death, non-fatal myocardial infarction, stroke, and repeat revascularization

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Genotyping guided therapy for anti-platelet management

Trial Overview

The study compares a personalized anti-platelet treatment plan based on genetic testing to the usual standard approach, aiming to see if tailoring medication can lower the risk of bleeding.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Personlized Therapy with CYP2C19 genotypingExperimental Treatment1 Intervention
Group II: Standard of Care TherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Citations

Clinical Utility of CYP2C19 Genotype-Guided Antiplatelet ...

In this review, we evaluate the impact of CYP2C19 genotype-guided selection of antiplatelet therapy on clinical outcomes, summarize emerging data from recent ...

Genotype-Guided Antiplatelet Therapy: JACC Review ...

In this review, we explore the clinical utility of pharmacogenetics in decision making for antiplatelet therapy, encompassing the most recent evidence and ...

Clinical Outcomes and Sustainability of Using CYP2C19 ...

The feasibility, sustainability and clinical impact of using CYP2C19 genotype-guided dual antiplatelet therapy (DAPT) selection in practice remains unclear.

CYP2C19 Genotype‐Guided Antiplatelet Therapy After ...

Real‐world data demonstrate lower atherothrombotic risk in CYP2C19 LOF carriers treated with alternative therapy versus clopidogrel and similar risk in those ...

The role of CYP2C19 genotyping to guide antiplatelet ...

This review considers whether there is sufficient data to support genotype guided antiplatelet therapy after stroke.

Genotype Guided Antiplatelet Therapy In Ischemic Stroke

Data on antiplatelet regimen, MACCE outcomes, and GUSTO outcomes will be collected at the follow-up visits. Blood tests will be performed on the genetic testing ...

Prospective CYP2C19 Genotyping to Guide Antiplatelet ...

Additionally, the secondary safety outcome of bleeding was significantly lower using a genotype-guided approach (HR, 0.78 [95% CI, 0.61–0.98]; P ...

CYP2C19 Genotype–Guided Antiplatelet Therapy in ...

The guidelines emphasize that using CYP2C19 genotype to guide antiplatelet therapy can help avoid standard-dose clopidogrel in genetically ...