Health TrialsbyHealthPanel

Investigating a Personalized Approach to Anti-Platelet Therapy

ConditionHigh Risk Bleeding
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years old

Receiving PCI with stenting

Disqualifiers

Inability to take ticagrelor

Inability to take clopidogrel

Not expected to survive >48hours

Not able to complete a buccal swab

Trial design

Design model

Sequential

Treatments tested in this trial

  • Genotyping guided therapy for anti-platelet management

    Drug

    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.

Treatment groups

1,760 Participants
are divided into 2 treatment groups
Group A: Standard of Care TherapyNo intervention 0 interventions
Group B: Personlized Therapy with CYP2C19 genotypingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bleeding Events

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

Time frame
Randomization to 12months

Secondary outcomes

1

MACCE Events

Composite of events of cardiovascular death, non-fatal myocardial infarction, stroke, and repeat revascularization.

Time frame
Randomization to 12months
2

CV mortality

Incidences of mortality associated with cardiovascular disease

Time frame
randomization to 12months
3

Non-Fatal MI

Number of incidences of non-fatal myocardial infarctions

Time frame
Randomization to 12months.
4

Stroke

Number of stroke events that occur

Time frame
randomization to 12months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: