Clopidogrel clinical studies

Antagonists of the ADP P2Y, 2 receptor, ticlopidine and its safer successor clopidogrel, are also potent inhibitors of platelet aggregation and have demonstrated their efficacy alone and on top of ASA in numerous in clinical studies. The results of the CAPRIE study, a large study involving 19,185 patients with recent Ml, stroke, or established peripheral arterial disease (PAD) demonstrated an 8.7% overall risk reduction versus ASA in the combined endpoints of the first occurrence of Ml, stroke, or other vascular death (30). 

The TEG using the platelet mapping assay with ADP as the agonist, and the recently developed VerifyNow P2YI2 assay have been proposed as reproducible point-of-care methods to assess platelet inhibition by clopidogrel (21,89,90). These methods are undergoing investigation in clinical studies. 

I 5 Kastrati A, Mehilli J, Schuhlen H, et al. Intracoronary stenting and antithrombotic regimen-rapid eariy action for coronary treatment study investigators. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med 2004 350 232-238. 

Wienbergen H, Gift AK, Schiele R, et al. MITRA PLUS Study Group. Comparison of clinical benefits of clopidogrel therapy in patients with acute coronary syndromes taking atorvastatin versus other statin therapies. Am J Cardiol 2003 92 285-288. 

Shi BS, Yoo SD (2007) Determination of clopidogrel in human plasma by liquid chromatog-raphy/tandem mass spectrometry application to a clinical pharmacokinetic study. Biomed... 

Fig. 19.1. Cumulative proportions of patients referred to the Early Use of Existing Preventive Strategies for Stroke (EXPRESS) study clinic in phases 1 — and 2 (—) prescribed new medication, (a) Any statin drug (in patients not already on a statin) (b) clopidogrel (usually in addition to aspirin) ...

Although ticlopidine has the same mechanism of action as clopidogrel and possesses a similar molecular structure, the results of clinical trials among the two agents are strikingly different. The Swedish Ticlopidine Multicenter Study (STIMS) had determined that ticlopidine therapy (500 mg/day) was able to reduce total mortality in comparison to placebo in patients with intermittent claudication p =... 

Dose may be an important factor as to whether or not a significant clinical interaction occurs. One study found that a high loading dose of clopidogrel (600 mg) was not affected by statins, but there is increased risk of serious bleeding with this dose. Lower doses of statins (e.g. atorvastatin 10 mg daily) also appear to be less likely to interact, and one study found that the effect was dose-dependent. ... 

Ranitidine In an open, two-period, two-treatment, crossover study in 47 healthy men, ranitidine had no clinically significant effects on the pharmacokinetics of the active metabolites of either prasugrel or clopidogrel [186 ]. 

---