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Clopidogrel

Phase 4FDA approved

Coronary Artery Disease | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Trials Updated: Nov 15, 2019

Clopidogrel development status

FDA approval on record Feb 27, 2002 as Plavix
Approval holderSanofi Aventis Us
ApplicationNDA020839
Highest phase Phase 4 (NCT00799045)
Phase scored for BMYPhase 3
Registered trials 98 across 41 sponsors since Apr 2003

Label indication Plavix is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. FDA label

Clopidogrel target and mechanism

Molecular targetP2RY12
Target classAntagonist
ModalitySmall molecule

Also known as Plavix

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment500

FDA Designations

No designations recorded

Clopidogrel clinical trials

Clopidogrel · 3 trials · 5 indications

Phase 3 1Phase 2 1Phase 1 1
NCT00330772Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting: The PAPA CABG StudyCoronary Artery Disease
COMPLETED150 Analytics
PHASE3COMPLETED
Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting: The PAPA CABG Study
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Graft patency, MI, Death, Stroke
Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI)
Approximately every 2 weeks for 8 weeks

The outcome measurement was on-treatment PRI determined through flow cytometric assessment of phosphorylation status of VASP.

Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
Period 2, Day 8

Secondary Endpoints

Bleeding, transfusion, re-exploration, Platelet function tests
Assess variability of thrombosis chamber measurements
Period 1 and Period 2
Assess relationship between platelet aggregation and thrombus formation
Period 1 and Period 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Clopidogrel - for CYP2C19*2 carriersACTIVE_COMPARATORClopidogrel for CYP2C19\*2 gene carriers
Clopidogrel - for CYP2C19*2 non-carriersACTIVE_COMPARATORClopidogrel for CYP2C19\*2 gene NON-carriers
Clopidogrel + AspirinEXPERIMENTAL -

Interventions

NameTypeDescription
AspirinDRUG -
ClopidogrelDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Patients 18 years of age or older * Undergoing on-pump, elective coronary artery bypass grafting with at least 2 free grafts * Patient able to give informed consent Exclusion Criteria: * planned date of surgery is \<5 days from planned recruitment date * patient has clear in...

Countries:CanadaUnited States
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Frequently asked questions about Clopidogrel

What is Clopidogrel?

Clopidogrel is a small molecule drug developed by Bristol-Myers Squibb Company (ticker: BMY). It is being studied in cardiovascular disease, coronary artery disease, and myocardial infarction. The drug is in Phase 1 development. It is an antagonist of P2RY12.

What is Clopidogrel used for?

Clopidogrel is used for cardiovascular disease, coronary artery disease, and myocardial infarction. It is being developed by Bristol-Myers Squibb Company (BMY). The drug is in Phase 1 of clinical development.

What does Clopidogrel target?

Clopidogrel targets P2RY12, a receptor. It acts as an antagonist. This mechanism is relevant to its development for cardiovascular disease, coronary artery disease, and myocardial infarction.

Who makes Clopidogrel?

Clopidogrel is made by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is developing the drug for cardiovascular disease, coronary artery disease, and myocardial infarction.

What phase is Clopidogrel in?

Clopidogrel is in Phase 1 of clinical development. It is investigational and has not been approved by the FDA. The drug is being developed by Bristol-Myers Squibb Company (BMY).

What clinical trials is Clopidogrel in?

Clopidogrel has been studied in clinical trials including NCT01235351, a Phase 2 trial in myocardial infarction and percutaneous coronary intervention; NCT00935506, a Phase 1 trial in cardiovascular disease; and NCT00330772, a Phase 3 trial in coronary artery disease and coronary artery bypass grafting. All are completed.