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Ticagrelor

Phase 3

Myocardial Infarction | Small molecule | Cardiovascular |Collegium Pharmaceutical, Inc.|Last Updated: Apr 21, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03251859Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot StudyPHASE3 COMPLETED 52Aug 11, 2017Feb 23, 2018Apr 21, 20231 Poland
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Study Endpoints
Primary Endpoints
Platelet Reactivity Assessed with the VASP assay
45 days

Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.

Secondary Endpoints
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
45 days
Number of Patients With High Platelet Reactivity according to the VASP assay
45 days
Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry
45 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Standard ticagrelor maintenance doseACTIVE_COMPARATORTicagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention.
Reduced ticagrelor maintenance doseEXPERIMENTALTicagrelor 90 mg twice daily for the first 30 days after myocardial infarction treated with percutaneous coronary intervention, then reduction of the maintenance dose to ticagrelor 60 mg twice daily for the next 15 days.
Interventions
NameTypeDescription
Ticagrelor 90 mgDRUGTicagrelor 90 mg twice daily
Ticagrelor 60 mgDRUGTicagrelor 60 mg daily
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * provision of informed consent prior to any study specific procedures * diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction according to the Third Universal Definition of Myocardial Infarction * index event treat...

Countries:Poland
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