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cangrelor P2Y12 inhibitor

Phase 3

Atherosclerosis | Small molecule | Cardiovascular |Novartis AG|Last Updated: Feb 4, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment11,145

FDA Designations

No designations recorded

Clinical trial landscape

cangrelor P2Y12 inhibitor · 1 trial · 3 indications

Phase 3 1
NCT01156571A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)Atherosclerosis
COMPLETED11,145 Analytics
PHASE3COMPLETED
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
48 hours after randomization

Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat \[mITT\] population)

Secondary Endpoints

Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)
48 hours after randomization
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild
48 hours after randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
cangrelorEXPERIMENTALCangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours. Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered.
clopidogrelACTIVE_COMPARATORClopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion. During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm.

Interventions

NameTypeDescription
cangrelor P2Y12 (platelet) inhibitorDRUG -
Clopidogrel - 300 or 600 mg (study arm)DRUGOver encapsulated tablets.
Clopidogrel 600 mg post cangrelorDRUGover-encapsulated clopidogrel (600 mg)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients may be included in the study if they meet all of the following criteria: * Male or non-pregnant female at least 18 years of age * Patients undergoing percutaneous coronary intervention (PCI): 1. Stable angina (SA) patients with diagnostic coronary angiography within...

Countries:United States
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Frequently asked questions about cangrelor P2Y12 inhibitor

What is cangrelor used for?

Cangrelor is an investigational small molecule being studied for use in atherosclerosis, specifically in patients who require percutaneous coronary intervention (PCI) and those with acute coronary syndrome. It is a P2Y12 inhibitor that has completed a Phase 3 clinical trial.

What does cangrelor target?

Cangrelor targets the P2Y12 receptor, a key player in platelet activation and aggregation. By inhibiting this receptor, cangrelor aims to prevent blood clots in patients undergoing percutaneous coronary intervention for atherosclerosis.

Who is developing cangrelor?

Cangrelor is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical development for cardiovascular indications.

What phase is cangrelor in?

Cangrelor is in Phase 3 clinical development. It has completed one Phase 3 trial, the CHAMPION PHOENIX study, which enrolled 11,145 patients. The drug is investigational and has not yet been approved by regulatory authorities.

What clinical trials is cangrelor in?

Cangrelor has been studied in one completed Phase 3 clinical trial, NCT01156571, known as CHAMPION PHOENIX. This randomized, double-blind, active-controlled trial compared cangrelor to clopidogrel standard therapy in subjects requiring percutaneous coronary intervention.

Is cangrelor the same as clopidogrel?

No, cangrelor is not the same as clopidogrel. Both are P2Y12 inhibitors used in cardiovascular procedures, but they are distinct drugs. In the CHAMPION PHOENIX trial, cangrelor was compared directly against clopidogrel as the active control.