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Clopidogrel

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

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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