High Risk BleedingPhase 4RAPID PREVENTNCT07602257
Investigating a Personalized Approach to Anti-Platelet Therapy
A Phase 4 study testing Genotyping guided therapy for anti-platelet management in people with High Risk Bleeding, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Bleeding
- What is being tested?
- Genotyping guided therapy for anti-platelet management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,760 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2026to 28 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Receiving PCI with stenting
Who cannot join
- Inability to take ticagrelor
- Inability to take clopidogrel
- Not expected to survive >48hours
- Not able to complete a buccal swab
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Poppy MacPhee, RN, 613-696-7000, pmacphee@ottawaheart.ca
Derek So, MD
About this study
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
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.
Read the 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.
- Conditions
- High Risk Bleeding
- Being tested
- Genotyping guided therapy for anti-platelet management
- Keywords
- Thrombosis, bleeding complications, Anti-platelet therapy
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotyping guided therapy for anti-platelet managementDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Genotyping guided therapy for anti-platelet management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Events
Events that meet the BARC Type 2, 3, or 5 definitions.
Measured: Randomization to 12months
Secondary outcomes (6)
MACCE Events
Composite of events of cardiovascular death, non-fatal myocardial infarction, stroke, and repeat revascularization.
Measured: Randomization to 12months
CV mortality
Incidences of mortality associated with cardiovascular disease
Measured: randomization to 12months
Non-Fatal MI
Number of incidences of non-fatal myocardial infarctions
Measured: Randomization to 12months.
Stroke
Number of stroke events that occur
Measured: randomization to 12months
Repeat revascularization
Incidences of events requiring additional unplanned revascularization procedures post randomization.
Measured: Randomization to 12months
Stent Thrombosis
Incidences of identified thrombosis of previous stents.
Measured: Randomization to 12months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion28 Dec 2029 (estimated)
- Study completion28 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk BleedingStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Monthly cluster randomization 1:1 for standard treatment vs personalized therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek So, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602257
- Sponsor's protocol ID
- 20260301-01H
- Acronym
- RAPID PREVENT
- Status last verified
- Nov 2026
- First submitted
- 15 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07602257
- Acronym / sponsor ID
- RAPID PREVENT / 20260301-01H
- Conditions
- High Risk Bleeding
- Keywords
- Thrombosis, bleeding complications, Anti-platelet therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,760 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 28 Dec 2029 (estimated)
- Study completion
- 28 Dec 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Monthly cluster randomization 1:1 for standard treatment vs personalized therapy
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Genotyping guided therapy for anti-platelet managementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years old
- Receiving PCI with stenting
Key exclusion criteria (4 listed)
- Inability to take ticagrelor
- Inability to take clopidogrel
- Not expected to survive >48hours
- Not able to complete a buccal swab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotyping guided therapy for anti-platelet managementParticipants 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. | Drug | Personlized Therapy with CYP2C19 genotyping |
Primary outcome
Bleeding Events
Time frame: Randomization to 12months
Events that meet the BARC Type 2, 3, or 5 definitions.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derek So, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genotyping guided therapy for anti-platelet management in people with High Risk Bleeding, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poppy MacPhee, RN (613-696-7000, pmacphee@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding Events (time frame: Randomization to 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.