Plavix
Authorised
This medicine is authorised for use in the European Union
clopidogrel
MedicineHumanAuthorised
Overview
Plavix is a medicine used to prevent problems caused by blood clots in adults who have:
- recently had a myocardial infarction (heart attack). Plavix can be started between a few days and 35 days after the attack;
- recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). Plavix can be started between seven days and six months after the stroke;
- peripheral arterial disease (problems with blood flow in the arteries);
- a condition known as ‘acute coronary syndrome’, when it should be given with acetylsalicylic acid (also known as aspirin). Acute coronary syndrome is a group of heart problems that includes heart attacks and unstable angina (a severe type of chest pain).
Some of these patients may be undergoing percutaneous coronary intervention (a procedure that unblocks blood vessels of the heart to restore its blood supply) and may have had a stent inserted (a short tube placed in an artery to prevent it closing up). Others may benefit from thrombolytic or fibrinolytic treatment (treatments to dissolve blood clots). - atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with acetylsalicylic acid. It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Plavix contains the active substance clopidogrel.
Plavix is available as tablets and can only be obtained with a prescription.
Plavix is taken once a day as a 75 mg tablet. Use of a loading dose (an initial higher dose) and the duration of treatment depend on the age of the patient and the disease being treated. For patients undergoing a percutaneous coronary intervention or eligible for thrombolytic or fibrinolytic therapy, treatment should start as early as possible after start of symptoms.
For more information about using Plavix, see the package leaflet or contact your doctor or pharmacist.
The active substance in Plavix, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. Blood clots are caused by cells in the blood called platelets sticking together. Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a receptor on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Plavix was more effective than acetylsalicylic acid at preventing new ischaemic events. In a study in around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral artery disease, 939 patients who were given Plavix experienced a new ischemic event (heart attack, ischaemic stroke or death) over a period of one to three years, compared with 1,020 patients who were given acetylsalicylic acid. This corresponds to a relative reduction in risk of 9% compared with acetylsalicylic acid and means that fewer patients will have new ischaemic events if they receive Plavix than if they receive acetylsalicylic acid.
In three studies involving over 61,000 patients with non?ST segment elevation acute coronary syndrome, 2,172 of whom had a stent inserted during the study, Plavix was given in combination with acetylsalicylic acid and compared with placebo (a dummy treatment). In these studies, which differed in duration from up to 8 days to up to one year, the overall relative risk of an event such as a blocked artery, another heart attack or death was reduced by 20% when patients were given Plavix and acetylsalicylic acid compared with placebo. There was also a reduction in the patients who had a stent inserted. In 2 studies in 49,000 patients with ST segment elevation myocardial infarction, fewer patients on Plavix had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
In a study in around 7,500 patients with atrial fibrillation who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy, patients were given Plavix together with acetylsalicylic acid or placebo for an average of three years. In this study, Plavix plus acetylsalicylic acid reduced the risk of new events by 11% compared with placebo taken with acetylsalicylic acid, with the largest reduction (28%) seen for stroke.
Study results published in medical journals showed that Plavix was effective for up to 12 months at reducing the occurrence of heart attack, stroke or death in patients treated for heart attack with ST-segment elevation who are having a percutaneous coronary intervention.
Bleeding reactions are the most common side effects reported with Plavix. The most common of these (which may affect up to 1 in 10 people) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bruising and bleeding where the skin is punctured.
Other side effects (which may affect up to 1 in 10 people) are diarrhoea, abdominal pain (stomach ache) and dyspepsia (heartburn).
For the full list of side effects of Plavix, see the package leaflet.
Plavix must not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients. It must not be used in patients who have severe liver disease or a disease that may cause bleeding such as a stomach ulcer or bleeding in the brain.
The European Medicines Agency decided that Plavix’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Plavix have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Plavix are continuously monitored. Suspected side effects reported with Plavix are carefully evaluated and any necessary action taken to protect patients.
Plavix received a marketing authorisation valid throughout the EU on 14 July 1998.
Product information
Latest procedure affecting product information: N/0154
05/07/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Plavix
- Active substance
- clopidogrel hydrogen sulfate
- International non-proprietary name (INN) or common name
- clopidogrel
- Therapeutic area (MeSH)
- Stroke
- Peripheral Vascular Diseases
- Atrial Fibrillation
- Myocardial Infarction
- Acute Coronary Syndrome
- Anatomical therapeutic chemical (ATC) code
- B01AC04
Pharmacotherapeutic group
Antithrombotic agentsTherapeutic indication
Secondary prevention of atherothrombotic events
Clopidogrel is indicated in:
- adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;
- adult patients suffering from acute coronary syndrome:
- non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA);
- ST-segment-elevation acute myocardial infarction, in combination with ASA in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy.
- In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)
Clopidogrel in combination with ASA is indicated in:- Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event.
Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
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