Timing of thienopyridine loading and outcomes in the TRITON trial: The FDA Prasugrel Action Package outlook

Cardiovascular Revascularization Medicine

Volumn 12, Issue 2, 2011, Pages 94-98

  Serebruany, Victor L ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Clinical trials; Clopidogrel; Loading dose; Prasugrel; Vascular outcomes

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; PRASUGREL;

ARTICLE; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; FIBRINOLYTIC THERAPY; FOOD AND DRUG ADMINISTRATION; HEART INFARCTION; HUMAN; LOADING DRUG DOSE; MEDICAL DOCUMENTATION; MORTALITY; OUTCOMES RESEARCH; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STROKE;

ASPIRIN; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG ADMINISTRATION SCHEDULE; DRUG APPROVAL; DRUG THERAPY, COMBINATION; HUMANS; MULTICENTER STUDIES AS TOPIC; MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; PIPERAZINES; PLATELET AGGREGATION INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; STENTS; THIOPHENES; TICLOPIDINE; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79952725579     PISSN: 15538389     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.carrev.2010.01.008     Document Type: Article

References (12)

1. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007, 357:2001-2015.
2. Prasugrel Secondary Review. Available for download at http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4412b1-00-FDA.htm.
3. Drug Approval Package. Available for download at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000TOC.cfm.
4. Serebruany VL, Shalito I, Kopyleva O Prasugrel development: claims and achievements. Thromb Haemost 2009, 101:14-22.
5. Wallentin L, Varenhorst C, James S, Erlinge D, Braun OO, Jakubowski JA, Sugidachi A, Winters KJ, Siegbahn A Prasugrel achieves greater and faster P2Y12receptor-mediated platelet inhibition than clopidogrel due to more efficient generation of its active metabolite in aspirin-treated patients with coronary artery disease. Eur Heart J 2008, 1:21-30.
6. Wiviott S, Antman E, Winters K, et al. Randomized comparison of prasugrel (CS-747, LY640315), a novel thienopyridine P2Y(12) antagonist, with clopidogrel in percutaneous coronary intervention. Results of the Joint Utilization of Medications to Block Platelets Optimally (JUMBO)-TIMI 26 Trial. Circulation 2005, 111:3366-3373.
7. Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA, Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001, 358:527-533.
8. Steinhubl SR, Berger PB, Mann JT, Fry ET, DeLago A, Wilmer C, Topol EJ, CREDO Investigators Clopidogrel for the reduction of events during observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002, 288:2411-2420.
9. Sabatine MS, Cannon CP, Gibson CM, López-Sendón JL, Montalescot G, Theroux P, Lewis BS, Murphy SA, McCabe CH, Braunwald E, Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY)-Thrombolysis in Myocardial Infarction (TIMI) 28 Investigators Effect of clopidogrel pretreatment before percutaneous coronary intervention in patients with ST-elevation myocardial infarction treated with fibrinolytics: the PCI-CLARITY study. JAMA 2005, 294:1224-1232.
10. Cohen M, Diez JE, Levine GN, Ferguson JJ, Morrow DA, Rao SV, Zidar JP, ACC, AHA Pharmacoinvasive management of acute coronary syndrome: incorporating the 2007 ACC/AHA guidelines: the CATH (cardiac catheterization and antithrombotic therapy in the hospital) Clinical Consensus Panel Report-III. J Invasive Cardiol 2007, 19:525-538.
11. Silber S, Richartz BM, Brilmayer M The European Society of Cardiology (ESC) guidelines for percutaneous coronary interventions (PCI). Herz 2006, 31:836-846. The European Society of Cardiology (ESC).
12. Sabatine MS, Hamdalla HN, Mehta SR, Fox KA, Topol EJ, Steinhubl SR, Cannon CP Efficacy and safety of clopidogrel pretreatment before percutaneous coronary intervention with and without glycoprotein IIb/IIIa inhibitor use. Am Heart J 2008, 155:910-917.