Daily. Med - PLAVIX - clopidogrel bisulfate tablet, film coated. CLINICAL STUDIES. The clinical evidence for the efficacy of PLAVIX is derived from four double- blind trials involving 8. CAPRIE study (Clopidogrel vs. Aspirin in Patients at Risk of Ischemic Events), a comparison of PLAVIX to aspirin, and the CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events), the COMMIT/CCS- 2 (Clopidogrel and Metoprolol in Myocardial Infarction Trial / Second Chinese Cardiac Study) studies comparing PLAVIX to placebo, both given in combination with aspirin and other standard therapy and CLARITY- TIMI 2. Clopidogrel as Adjunctive Reperfusion Therapy – Thrombolysis in Myocardial Infarction).

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Recent Myocardial Infarction (MI), Recent Stroke or Established Peripheral Arterial Disease. The CAPRIE trial was a 1. PLAVIX (7. 5 mg daily) to aspirin (3. The patients randomized had: 1) recent histories of myocardial infarction (within 3.

Patients received randomized treatment for an average of 1. The trial's primary outcome was the time to first occurrence of new ischemic stroke (fatal or not), new myocardial infarction (fatal or not), or other vascular death. Deaths not easily attributable to nonvascular causes were all classified as vascular. As shown in the table, PLAVIX (clopidogrel bisulfate) was associated with a lower incidence of outcome events of every kind. The overall risk reduction (9.

P=0. 0. 45. Similar results were obtained when all- cause mortality and all- cause strokes were counted instead of vascular mortality and ischemic strokes (risk reduction 6. In patients who survived an on- study stroke or myocardial infarction, the incidence of subsequent events was again lower in the PLAVIX group. The curves showing the overall event rate are shown in Figure 1. The event curves separated early and continued to diverge over the 3- year follow- up period. CHART. Although the statistical significance favoring PLAVIX over aspirin was marginal (P=0. Thus, the difference between PLAVIX and placebo, although not measured directly, is substantial. The CAPRIE trial included a population that was randomized on the basis of 3 entry criteria.

The efficacy of PLAVIX relative to aspirin was heterogeneous across these randomized subgroups (P=0. It is not clear whether this difference is real or a chance occurrence.

Although the CAPRIE trial was not designed to evaluate the relative benefit of PLAVIX over aspirin in the individual patient subgroups, the benefit appeared to be strongest in patients who were enrolled because of peripheral vascular disease (especially those who also had a history of myocardial infarction) and weaker in stroke patients. In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, PLAVIX was not numerically superior to aspirin. In the meta- analyses of studies of aspirin vs.

There was a suggestion of heterogeneity in these studies too, with the effect strongest in patients with a history of myocardial infarction, weaker in patients with a history of stroke, and not discernible in patients with a history of peripheral vascular disease. With respect to the inferred comparison of PLAVIX to placebo, there is no indication of heterogeneity. Acute Coronary Syndrome. The CURE study included 1. ST segment elevation (unstable angina or non- Q- wave myocardial infarction) and presenting within 2. Patients were required to have either ECG changes compatible with new ischemia (without ST segment elevation) or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.

The patient population was largely Caucasian (8. Patients also received aspirin (7.

The use of GPIIb/IIIa inhibitors was not permitted for three days prior to randomization. The number of patients experiencing the primary outcome (CV death, MI, or stroke) was 5. The Full Harold And Lillian Poster (2017) Movie.

PLAVIX- treated group and 7. CI of 1. 0%–2. 8%; p=0.

PLAVIX- treated group (see Table 3). At the end of 1. 2 months, the number of patients experiencing the co- primary outcome (CV death, MI, stroke or refractory ischemia) was 1. PLAVIX- treated group and 1. CI of 6%–2. 1%, p=0. PLAVIX- treated group (see Table 3). In the PLAVIX- treated group, each component of the two primary endpoints (CV death, MI, stroke, refractory ischemia) occurred less frequently than in the placebo- treated group.

The benefits of PLAVIX (clopidogrel bisulfate) were maintained throughout the course of the trial (up to 1. CHART 2. In CURE, the use of PLAVIX was associated with a lower incidence of CV death, MI or stroke in patient populations with different characteristics, as shown in Figure 3. The benefits associated with PLAVIX were independent of the use of other acute and long- term cardiovascular therapies, including heparin/LMWH (low molecular weight heparin), IV glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors, lipid- lowering drugs, beta- blockers, and ACE- inhibitors. The efficacy of PLAVIX was observed independently of the dose of aspirin (7. The use of oral anticoagulants, non- study anti- platelet drugs and chronic NSAIDs was not allowed in CURE. The use of PLAVIX in CURE was associated with a decrease in the use of thrombolytic therapy (7.

The use of PLAVIX in CURE did not impact the number of patients treated with CABG or PCI (with or without stenting), (2. Patients were randomized to receive PLAVIX (7.

The co- primary endpoints were death from any cause and the first occurrence of re- infarction, stroke or death. The patient population included 2. CHART 3. The effect of PLAVIX did not differ significantly in various pre- specified subgroups as shown in Figure 6.

Additionally, the effect was similar in non- prespecified subgroups including those based on infarct location, Killip class or prior MI history (see Figure 7). Such subgroup analyses should be interpreted very cautiously. The randomized, double- blind, placebo- controlled CLARITY trial included 3,4. U. S., presenting within 1. ST elevation myocardial infarction and planned for thrombolytic therapy.

Patients were randomized to receive PLAVIX (3. Day 8. Patients also received aspirin (1. The patients were followed for 3. The primary endpoint was the occurrence of the composite of an occluded infarct- related artery (defined as TIMI Flow Grade 0 or 1) on the predischarge angiogram, or death or recurrent myocardial infarction by the time of the start of coronary angiography. The patient population was mostly Caucasian (8. A total of 9. 9. 7% of patients received fibrinolytics (fibrin specific: 6.

ACE inhibitors and 6. Soy Nero (2017) Free Online. The number of patients who reached the primary endpoint was 2. PLAVIX- treated group and 3.