PLAVIX in Treatment Guidelines
ACC/AHA Classification

The table below shows the ACC/AHA Guideline Update for the Management of Patients with Unstable Angina and Non–ST–Segment Elevation Myocardial Infarction (UA/NSTEMI).

Class/Level of Evidence 18

Class I Conditions for which there is evidence and/or general agreement that the procedure or treatment is useful and effective.
Class II Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.
Class IIa Weight of evidence/opinion is in favor of usefulness/efficacy.
Class IIb Usefulness/efficacy is less well established by evidence/opinion.
Class III Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective and in some cases may be harmful.
Level of Evidence A:
Highest Rank 		Data derived from multiple randomized clinical trials that involved large numbers of patients.
Level of Evidence B:
Intermediate Rank 		Data derived from a limited number of randomized trials that involved small numbers of patients or from careful analyses of nonrandomized studies or observational registries.
Level of Evidence C:
Lower Rank 		Expert consensus was the primary basis for recommendation.
Indications
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Use PLAVIX plus aspirin for patients with non–ST–segment elevation acute coronary syndrome (UA/non–Q–wave MI), including patients to be managed medically and those to be managed with percutaneous coronary intervention (with or without stent) or CABG, to decrease the rate of a combined end point of CV death, MI, or stroke as well as the rate of a combined end point of CV death, MI, stroke, or refractory ischemia.

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Use PLAVIX plus aspirin for patients with ST–segment elevation acute myocardial infarction to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

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Use PLAVIX alone for patients with a history of recent stroke, recent MI, or established PAD to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Important Risk Information 18
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PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.*)

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The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo
plus aspirin in clinical trials. (See ADVERSE REACTIONS.*)

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Due to an expected reduction in drug levels and clinical efficacy, concomitant use of drugs that inhibit CYP2C19 (eg, omeprazole) should be discouraged. (See PRECAUTIONS.*)

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As part of the worldwide post–marketing experience with PLAVIX, there have been cases of reported thrombotic thrombocytopenic purpura (TTP), some with fatal outcome. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). (See WARNINGS.*)

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Based on literature, patients with genetically reduced CYP2C19 function have diminished responses and generally exhibit higher CV event rates following MI. (See PRECAUTIONS.*)

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In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)