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Not yet recruiting NCT07602257

Investigating a Personalized Approach to Anti-Platelet Therapy

Phase IV Interventional High Risk Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genotyping guided therapy for anti-platelet management.
Who it may be relevant to
Registry conditions: High Risk Bleeding. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Reassessment of Anti-Platelet Therapy Using an Individualized Strategy With Pharmacogenomics to Refine Anti-Platelet Drugs in Vulnerable Patients to Eliminate Thrombotic and Bleeding Complications - A Cluster Randomized Pilot Study

Overview

RAPID PREVENT aims to identify if a personalized (targeted) anti-platelet strategy will reduce bleeding events when compared to the current standard anti-platelet therapy.

Detailed description

RAPID PREVENT is a Phase IV, single centre, physician initiated, cluster randomized pilot trial evaluating a personalized antiplatelet strategy for patients with acute coronary syndrome (ACS) with High Bleeding Risk (HBR) undergoing percutaneous coronary intervention (PCI). Monthly clusters are randomized 1:1 to either standard of care or personalized therapy guided by HBR algorithm and point of care CYP2C19 genotyping.

Interventions

  • Drug Genotyping guided therapy for anti-platelet management
    Participants that are carriers of the CYP2C19 gene will receive either Ticagrelor monotherapy, or dual therapy with Ticagrelor and Aspirin. Participants that are not carriers of the CYP2C19 gene will receive either Plavix monotherapy or dual therapy with Plavix and Aspirin.

Primary outcome measures

  • Bleeding Events [Time frame: Randomization to 12months]
Secondary outcome measures (6)
  • MACCE Events [Time frame: Randomization to 12months]
  • CV mortality [Time frame: randomization to 12months]
  • Non-Fatal MI [Time frame: Randomization to 12months.]
  • Stroke [Time frame: randomization to 12months]
  • Repeat revascularization [Time frame: Randomization to 12months]
  • Stent Thrombosis [Time frame: Randomization to 12months.]

Eligibility criteria

Inclusion criteria

  • Age >18 years old
  • Receiving PCI with stenting

Exclusion criteria

  • Inability to take ticagrelor
  • Inability to take clopidogrel
  • Not expected to survive >48hours
  • Not able to complete a buccal swab

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Prevention

Study locations

Canada · 1 center
  • University of Ottawa Heart Institute — Ottawa

Identifiers

NCT: NCT07602257 · 20260301-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗