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Plavix (clopidogrel)

Plavix (generic name: clopidogrel) is a Thienopyridine antiplatelet agent Small molecule drug developed by Generic (originally Sanofi/BMS). It is currently FDA-approved (first approved 1997) for Acute ST segment elevation myocardial infarction, Acute coronary syndrome, Atrial fibrillation. Also known as: Plavix.

Irreversibly blocks the P2Y12 ADP receptor on platelets, inhibiting platelet aggregation and preventing arterial thrombosis.

Plavix, also known as clopidogrel, is a small molecule antiplatelet medication used to reduce the risk of heart disease and stroke in those at high risk. It is taken by mouth and its effect starts about two hours after intake, lasting for five days.

At a glance

Mechanism of action

Clopidogrel is a prodrug that requires hepatic CYP2C19 metabolism to its active thiol metabolite, which irreversibly blocks the P2Y12 ADP receptor on platelets for their entire lifespan (~7-10 days). It is a cornerstone of dual antiplatelet therapy (DAPT) after coronary stenting and acute coronary syndromes. As Plavix, it was the second best-selling drug in history.

Approved indications

• Acute ST segment elevation myocardial infarction
• Acute coronary syndrome
• Atrial fibrillation
• Cerebral embolism
• Myocardial Reinfarction Prevention
• Non-Q wave myocardial infarction
• Peripheral Arterial Thromboembolism Prevention
• Prevention blood clots forming in hardened blood vessels
• Prevention of blood clots after heart attack or stroke
• Unstable angina

Boxed warnings

• WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE The effectiveness of clopidogrel results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] . Clopidogrel at recommended doses forms less of the active metabolite and so has a reduced effect on platelet activity in patients who are homozygous for nonfunctional alleles of the CYP2C19 gene, (termed “CYP2C19 poor metabolizers”). Tests are available to identify patients who are CYP2C19 poor metabolizers [see Clinical Pharmacology (12.5) ] . Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE See full prescribing information for complete boxed warning. Effectiveness of clopidogrel depends on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. ( 5.1 , 12.3 ) Tests are available to identify patients who are CYP2C19 poor metabolizers. (12.5) Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. ( 5.1)

Common side effects

• Major Bleeding
• Minor Bleeding
• Other noncerebral bleeding (nonmajor)
• Any noncerebral bleeding
• Life-threatening bleeding
• Gastrointestinal hemorrhage
• Other major bleeding
• Requiring transfusion (≥4 units)
• Requiring 2-3 units of blood
• Pruritus
• Epistaxis
• Hematuria

Serious adverse events

• Fatal bleeding
• Intracranial hemorrhage
• Hemorrhagic stroke
• Requiring surgical intervention
• Requiring inotropes
• Hemoglobin drop ≥5 g/dL
• Significantly disabling bleeding
• Intraocular bleeding with significant loss of vision
• Bleeding requiring hospitalization

Key clinical trials

• Long-Term Safety and Efficacy of Drug Eluting Stents in "Real World" - Results From the FReIburger STent Registry (N/A)
• An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation (Phase 4)
• Thrombocyte Activity Reassessment and GEnoTyping for PCI(TARGET-PCI) (NA)
• The Role of DLBS1033 in The Management of Acute Non-ST Elevation of Myocardial Infarction (NSTEMI) Without Early Coronary Revascularization (Phase 2)
• Platelet Reactivity Over Time After Receiving Clopidogrel Among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention (N/A)
• Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation (Phase 4)
• POPular GUILTY PILOT: Genotype-guided Clopidogrel Monotherapy (Phase 2)
• HOST-EXAM-Ex : Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - EXtended Antiplatelet Monotherapy - EXtended Follow up (N/A)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Plavix CI brief — competitive landscape report
• Plavix updates RSS · CI watch RSS
• Generic (originally Sanofi/BMS) portfolio CI

Frequently asked questions about Plavix

Related

• Drug class: All Thienopyridine antiplatelet agent drugs
• Target: All drugs targeting Cytochrome P450 2B6, P2Y purinoceptor 12, Sodium-dependent serotonin transporter
• Manufacturer: Generic (originally Sanofi/BMS) — full pipeline
• Therapeutic area: All drugs in Metabolic
• Indication: Drugs for Acute ST segment elevation myocardial infarction
• Indication: Drugs for Acute coronary syndrome
• Indication: Drugs for Atrial fibrillation
• Also known as: Plavix

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing