Acute Coronary Syndrome — WilL LOWer Dose Aspirin be More Effective Following ACS? (WILLOW-ACS)
Citation(s)
Antithrombotic Trialists' Collaboration Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. Erratum in: BMJ 2002 Jan 19;324(7330):141.
Cannon CP, Husted S, Harrington RA, Scirica BM, Emanuelsson H, Peters G, Storey RF; DISPERSE-2 Investigators Safety, tolerability, and initial efficacy of AZD6140, the first reversible oral adenosine diphosphate receptor antagonist, compared with clopidogrel, in patients with non-ST-segment elevation acute coronary syndrome: primary results of the DISPERSE-2 trial. J Am Coll Cardiol. 2007 Nov 6;50(19):1844-51. Epub 2007 Oct 23. Erratum in: J Am Coll Cardiol. 2007 Nov 27;50(22):2196.
Cattaneo M, Lecchi A Inhibition of the platelet P2Y12 receptor for adenosine diphosphate potentiates the antiplatelet effect of prostacyclin. J Thromb Haemost. 2007 Mar;5(3):577-82. Epub 2006 Dec 7. Erratum in: J Thromb Haemost. 2007 May;5(5):1094.
Kallmann R, Nieuwenhuis HK, de Groot PG, van Gijn J, Sixma JJ Effects of low doses of aspirin, 10 mg and 30 mg daily, on bleeding time, thromboxane production and 6-keto-PGF1 alpha excretion in healthy subjects. Thromb Res. 1987 Feb 15;45(4):355-61.
Storey RF, Oldroyd KG, Wilcox RG Open multicentre study of the P2T receptor antagonist AR-C69931MX assessing safety, tolerability and activity in patients with acute coronary syndromes. Thromb Haemost. 2001 Mar;85(3):401-7.
Tohgi H, Konno S, Tamura K, Kimura B, Kawano K Effects of low-to-high doses of aspirin on platelet aggregability and metabolites of thromboxane A2 and prostacyclin. Stroke. 1992 Oct;23(10):1400-3.
Valkhoff VE, Sturkenboom MC, Kuipers EJ Risk factors for gastrointestinal bleeding associated with low-dose aspirin. Best Pract Res Clin Gastroenterol. 2012 Apr;26(2):125-40. doi: 10.1016/j.bpg.2012.01.011. Review.
Vane JR, Botting RM The mechanism of action of aspirin. Thromb Res. 2003 Jun 15;110(5-6):255-8. Review.
Warner TD, Armstrong PC, Curzen NP, Mitchell JA Dual antiplatelet therapy in cardiovascular disease: does aspirin increase clinical risk in the presence of potent P2Y12 receptor antagonists? Heart. 2010 Nov;96(21):1693-4. doi: 10.1136/hrt.2010.205724.
Warner TD, Nylander S, Whatling C Anti-platelet therapy: cyclo-oxygenase inhibition and the use of aspirin with particular regard to dual anti-platelet therapy. Br J Clin Pharmacol. 2011 Oct;72(4):619-33. doi: 10.1111/j.1365-2125.2011.03943.x. Review.
Ye Y, Birnbaum GD, Perez-Polo JR, Nanhwan MK, Nylander S, Birnbaum Y Ticagrelor protects the heart against reperfusion injury and improves remodeling after myocardial infarction. Arterioscler Thromb Vasc Biol. 2015 Aug;35(8):1805-14. doi: 10.1161/ATVBAHA.115.305655. Epub 2015 Jun 4.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.