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Ticagrelor

Phase 3

Acute Myocardial Infarction | Small molecule | Cardiovascular |Unity Biotechnology, Inc.|Last Updated: Nov 22, 2016

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_CONTROLLEDDMC
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01930591Ticagrelor for PCI Post ThrombolysisPHASE3 COMPLETED 140May 1, 2014Nov 1, 2016Nov 22, 20165 Canada
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Study Endpoints
Primary Endpoints
Therapeutic platelet inhibition
4 hours

Therapeutic platelet inhibition as determined by VerifyNow assay (PRU value \<208) at 4±1 hours post PCI

Secondary Endpoints
Therapeutic platelet inhibition
24 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Clopidogrel armACTIVE_COMPARATORClopidogrel 300 mg before PCI followed by 75 mg po OD
Ticagrelor armEXPERIMENTALTicagrelor 180 mg before PCI followed by 90 mg po BID
Interventions
NameTypeDescription
TicagrelorDRUG180 mg bolus followed by 90 mg BID
ClopidogrelDRUG300 mg bolus followed by 75 mg OD
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Age 18 years and over. 2. Planned PCI between 4-24 hours after administration of fibrinolytic therapy for STEMI. 3. Treatment with aspirin and clopidogrel as an adjunct to fibrinolytic therapy. 4. Informed written consent. Exclusion Criteria: 1. Atrial fibrillation or need ...

Countries:Canada
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