Abstract
Results that dictate a reduction in end points observed in a few hallmark and other recent randomized clinical trials (RCTs) are given. The appropriate reference source is given so that the reader can explore the details of the RCT if required. Because of the constraints of available space, only a brief comment is given in the text regarding the results and their implications.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Guyatt GH, Sackett DL, Cook DJ. The medical literature: Users’ guide to the medical literature: II. How to use an article about therapy or prevention: A. Are the results of the study valid? JAMA 1993;270:2590–2601; B. What were the results and will they help me in caring for my patients? JAMA 1994;271:59–63.
Antman EM, Califf RM, Kupersmith J. Tools for assessment of cardiovascular tests and therapies. In: Antman EM. Cardiovascular Therapeutics, 2nd ed. Philadelphia, WB Saunders, 2002, pp. 1–19.
The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006;354:1464–1476.
The OASIS-6 Trial Investigators. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction. The OASIS-6 randomized trial. JAMA 2006;295: 1519–1530.
Califf RM. Fondaparinux in ST-segment elevation myocardial infarction. The drug, the strategy, the environment, or all of the above? JAMA 2006;295:1579–1580.
Antman EM, Morrow DA, McCabe CH, et al. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction for the ExTRACT-TIMI 25 Investigators. N Engl J Med 2006; 354:1477–1488.
Stone GW, Bertrand M, Colombo A, et al. Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: Study design and rationale. Am Heart J 2004;148:764–775.
ACUITY: Stone GW, McLaurin BT, Cox DA, et al. for the ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med 2006;355:2203–2216.
TACTICS-TIMI-18 Investigators. Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein Ilb/IIIa inhibitor tirofiban. N Engl J Med 2001;344:1879–1887.
CAPRICORN Investigators. Effect of carvedilol on outcome after MI in patients with left ventricular dysfunction; The CAPRICORN randomized trial. Lancet 2001;357:1385–1390.
Carvedilol Prospective Randomized Cumulative Survival Study Group. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001;344:1651–1658.
MERIT-HF Study Group. The Metoprolol CR/XL Randomized Intervention Trial in CHF. Effects of controlled-release metoprolol on total mortality, hospitalizations and well-being in patients with heart failure. JAMA 2000;283:1295–1302.
RALES: The Randomized Aldactone Evaluation Study Investigators. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999;341:709–717.
EPHESUS: Pitt B, Remme W, Zannad F, et al. for the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 2003;348:1309–1321.
CHARM: Granger CB, McMurray JJV, Yusuf S, et al. for the CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and reduced left ventricular systolic function intolerant to angiotensin converting enzyme inhibitors; the CHARM-Alternative trial. Lancet 2003;362: 772–776.
A-HeFT: Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004;351:2049–2057.
HOPE: Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting enzyme inhibitor, ramipril, on cardiovascular events in high risk patients. N Engl J Med 2000;342: 145–153.
The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002;288:2981–2997.
Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004;350:1495–1504.
PROVE IT-TIMI22: Ray KK, Cannon CP, McCabe CH, et al. for the PROVE IT-TIMI22 Investigators. Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: Results from the PROVE IT-TIMI 22 trial. J Am Coll Cardiol 2005;46:1405–1410.
Ridker PM, Cannon CP, Morrow D, et al. for the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-reactive protein levels and outcomes after statin therapy. N Engl J Med 2005;352:20–28.
ASTEROID: Nissen SE, Nicholls SJ, Sipahi I, et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: The ASTEROID trial. JAMA 2006;295:1556–1565.
Blumenthal RS, Kapur NK. Can a potent statin actually regress coronary atherosclerosis? JAMA 2006; 295:1583–1584.
Grundy SM, Cleeman JI, Merz CNB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004; 110:227–239.
Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: A randomised placebo-controlled trial. Lancet 2002; 360:7–22.
Shepherd J, Blauw GJ, Murphy MB, et al. Pravastatin in elderly individuals at risk of vascular disease: A randomised controlled trial. Lancet 2002;360:1623–1630.
CARE: For the Cholesterol and Recurrent Events Trial Investigators. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med 1996;335:1001.
LIPID Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998;339:1349–1357.
AFIRM: The Atrial Fibrillation Follow-up Investigation of Rhythm Management Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 2002;347: 1825.
GEMINI: Bakris GL, Fonseca V, Katholi RE, et al. Metabolic effects of carvedilol vs metoprolol in patients with type 2 diabetes mellitus and hypertension: A randomized controlled trial. JAMA 2004;292: 2227–2236.
Sabatine MS, Cannon CP, Gibson CM. Effect of clopidogrelpretreatment before percutaneous coronary intervention in patients with ST-elevation myocardial infarction treated with fibrinolytics. JAMA 2005; 294:1224–1232.
COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) Collaborative Group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: Randomised placebo-controlled trial. Lancet 2005;366:1607–1621.
COMMIT/CCS-2 (Clopidogrel and Metoprolol in Myocardial Infarction Trial) Collaborative Group. Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: Randomised placebo-controlled trial. Lancet 2005;366:1622–1632.
CHARISMA: Bhatt DL, Fox KAA, Hacke W, for the CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med 2006;354:1706–1717.
HOPE 2: The Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. Homocysteine lowering with folic acid and B vitamins in vascular disease. N Engl J Med 2006;354:1567–1577.
Suggested Reading
ACUITY: Stone GW, McLaurin BT, Cox DA, et al. for the ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med 2006;355:2203–2216.
Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004;350:1495–1504.
COMMIT (Clopidogrel and Metoprolol in Myocardial Infarction Trial) Collaborative Group. Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: Randomised placebocontrolled trial. Lancet 2005;366:1622–1632.
COMMIT (Clopidogrel and Metoprolol in Myocardial Infarction Trial) Collaborative Group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: Randomised placebo-controlled trial. Lancet 2005;366:1607–1621.
Davis BR, Piller LB, Cutler JA, et al. for the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Collaborative Research Group. Role of diuretics in the prevention of heart failure: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Circulation 2006;113:2201–2210.
Rahman M, Pressel S, Davis BR, et al. for the ALLHAT Collaborative Research Group. Cardiovascular outcomes in high-risk hypertensive patients stratified by baseline glomerular filtration rate. Ann Inter Med 2006;144:172–180.
Stevens LA, Coresh J, Greene T. Assessing kidney function—measured and estimated glomerular filtration rate. N Engl J Med 2006;354:2473–2483.
Tu K, Gunraj N, Mamdani M. Is ramipril really better than other angiotensin-converting enzyme inhibitors after acute myocardial infarction? 2006;98 6–9.
Rights and permissions
Copyright information
© 2007 Humana Press Inc., Totowa, NJ
About this chapter
Cite this chapter
(2007). Hallmark Clinical Trials. In: Cardiac Drug Therapy. Contemporary Cardiology. Humana Press. https://doi.org/10.1007/978-1-59745-238-0_22
Download citation
DOI: https://doi.org/10.1007/978-1-59745-238-0_22
Publisher Name: Humana Press
Print ISBN: 978-1-58829-904-8
Online ISBN: 978-1-59745-238-0
eBook Packages: MedicineMedicine (R0)