NCT07602257

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,760

participants targeted

Target at P75+ for phase_4

Timeline
42mo left

Started Jun 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Dec 2029

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2029

Last Updated

May 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Thrombosisbleeding complicationsAnti-platelet therapy

Outcome Measures

Primary Outcomes (1)

  • Bleeding Events

    Events that meet the BARC Type 2, 3, or 5 definitions.

    Randomization to 12months

Secondary Outcomes (6)

  • MACCE Events

    Randomization to 12months

  • CV mortality

    randomization to 12months

  • Non-Fatal MI

    Randomization to 12months.

  • Stroke

    randomization to 12months

  • Repeat revascularization

    Randomization to 12months

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care Therapy

NO INTERVENTION

Participants randomized to standard of care will receive the standard treatment for this condition.

Personlized Therapy with CYP2C19 genotyping

EXPERIMENTAL

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

Interventions

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.

Personlized Therapy with CYP2C19 genotyping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old
  • Receiving PCI with stenting

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Derek So, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Poppy MacPhee, RN

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study, participants and clinicians cannot be blinded to the study treatment, however outcome adjudicators will remain blinded.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Monthly cluster randomization 1:1 for standard treatment vs personalized therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 28, 2029

Study Completion (Estimated)

December 28, 2029

Last Updated

May 22, 2026

Record last verified: 2026-04

Locations