PLAVIX in Treatment Guidelines


PLAVIX is supported by multiple Class I Guidelines for ischemic stroke, ACS and PAD8,9,10

Read more about these guidelines and use of PLAVIX:





Despite the Guideline recommendations above, many patients do not receive PLAVIX

43% of non-stented patients with NSTEMI did not receive PLAVIX upon discharge despite guideline recommendations11

Clopidogrel Use in Non-Stented Patients With NSTEMI9

Clopidogrel use in NSTEMI patients was 98% for PCI, and 57% for non-stented.

ACTION=Acute Coronary Treatment and Intervention Outcomes Network Registry is a national quality improvement initiative for patients with acute coronary syndromes (ACS), including patients with NSTEMI. American College of Cardiology/American Heart Association (ACC/AHA) Duke Clinical Research Institute. The ACTION Registry measures patients demographics, drug therapies provided acutely and at discharge, procedures performed and lab test results, adverse events, and compliance with ACC/AHA Guideline recommendations.

ACTION is funded by the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.


The ACC/AHA task force on performance measures has included the following test measure in its 2008 performance measure set:12

  • Medically treated acute myocardial infarction patients who do not undergo PCI during hospitalization should be prescribed clopidogrel at discharge11

Many ACS patients do not receive clopidogrel upon hospital discharge

Despite guideline recommendations, 69% of NSTEMI patients who underwent CABG did not receive clopidogrel upon discharge


Clopidogrel Use in NSTEMI Patients Upon Discharge9

Patients with NSTEMI receiving clopidogrel upon discharge were 98% for PCI, 57% for non-stented, and 31% for CABG.

ACTION=Acute Coronary Treatment and Intervention Outcomes Network Registry is a national quality improvement initiative for patients with acute coronary syndromes (ACS), including patients with NSTEMI. American College of Cardiology/American Heart Association (ACC/AHA) Duke Clinical Research Institute. The ACTION Registry measures patients demographics, drug therapies provided acutely and at discharge, procedures performed and lab test results, adverse events, and compliance with ACC/AHA Guideline recommendations.

ACTION is funded by the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.


Initiation of clopidogrel for CV risk reduction is often delayed11

Percentage of NSTEMI patients started on clopidogrel in the first 24 hours (N=32,377)

61% of patients received clopidogrel, 39% did not receive clopidogrel.

ACTION=Acute Coronary Treatment and Intervention Outcomes Network Registry is a national quality improvement initiative for patients with acute coronary syndromes (ACS), including patients with NSTEMI. American College of Cardiology/American Heart Association (ACC/AHA) Duke Clinical Research Institute. The ACTION Registry measures patients demographics, drug therapies provided acutely and at discharge, procedures performed and lab test results, adverse events, and compliance with ACC/AHA Guideline recommendations.

ACTION is funded by the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.


The ACC/AHA recommend PLAVIX 300 mg loading dose = aspirin as soon as possible after admission for UA/NSTEMI patients.9

PLAVIX was not the only agent recommended. Please refer to the full text of the ACC/AHA Guidelines for all recommendations and sequencing of therapies.

‡These do not represent the complete ACC/AHA 2007 guideline recommendations. Please visit http://www.acc.org to access the complete recommendations.


Important Risk Information

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.*)

The metabolism of PLAVIX can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19 (eg,omeprazole), causing reduced effectiveness. Avoid use of PLAVIX in patients with impaired CYP2C19 function due to known genetic variation or due to drugs that inhibit CYP2C19 activity. (See WARNINGS and PRECAUTIONS: Drug Interactions.*)

As part of the worldwide postmarketing 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.*)

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.*)

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.*)

*Please See the Full PLAVIX Prescribing Information

PLAVIX Indications

PLAVIX® (clopidigrel bisulfate) is indicated for the reduction of atherothrombotic events as follows:

–
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.

–
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.

–
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.