Investigating a Personalized Approach to Anti-Platelet Therapy

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07602257

Acronym

RAPID PREVENT

Enrollment

1760

Registered

2026-05-22

Start date

2026-10-01

Completion date

2029-12-28

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Bleeding

Keywords

Thrombosis, bleeding complications, Anti-platelet therapy

Brief summary

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

DRUGGenotyping 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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

Due to the nature of the study, participants and clinicians cannot be blinded to the study treatment, however outcome adjudicators will remain blinded.

Intervention model description

Monthly cluster randomization 1:1 for standard treatment vs personalized therapy

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bleeding Events	Randomization to 12months	Events that meet the BARC Type 2, 3, or 5 definitions.

Secondary

Measure	Time frame	Description
CV mortality	randomization to 12months	Incidences of mortality associated with cardiovascular disease
Non-Fatal MI	Randomization to 12months.	Number of incidences of non-fatal myocardial infarctions
MACCE Events	Randomization to 12months	Composite of events of cardiovascular death, non-fatal myocardial infarction, stroke, and repeat revascularization.
Repeat revascularization	Randomization to 12months	Incidences of events requiring additional unplanned revascularization procedures post randomization.
Stent Thrombosis	Randomization to 12months.	Incidences of identified thrombosis of previous stents.
Stroke	randomization to 12months	Number of stroke events that occur

Countries

Canada

Contacts

CONTACTPoppy MacPhee, RN

pmacphee@ottawaheart.ca613-696-7000

PRINCIPAL_INVESTIGATORDerek So, MD

Ottawa Heart Institute Research Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026