Investigating a Personalized Approach to Anti-Platelet Therapy (RAPID PREVENT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: High Risk Bleeding
• Intervention / Treatment: Drug: Genotyping guided therapy for anti-platelet management

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.

• Study Type: Interventional
• Enrollment (Estimated): 1760
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Poppy MacPhee, RN; Phone Number: 613-696-7000; Email: pmacphee@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
      • Principal Investigator: Derek So, MD
      • Contact: Poppy MacPhee, RN; Phone Number: 613-696-7000; Email: pmacphee@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Therapy; Participants randomized to standard of care will receive the standard treatment for this condition.
Experimental: Personlized Therapy with CYP2C19 genotyping; Participants randomized to this arm will completed a point of care genotyping test to determine the presence or absence of the CYP2C19 gene, and the anti-platelet therapy will be determined by if the gene is present or not.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Derek So, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Thrombosis; Anti-platelet therapy; bleeding complications
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 20260301-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No