Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack. - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00251576

Purpose

A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate the effectiveness of one type of blood thinner as compared to another type of blood thinner.

Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated with diet and 4 months placebo followed by diet and approved drug) in patients who have experienced acute chest pain or heart attack.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: A-Phase: tirofiban; Z-Phase simvastatin Drug: Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years Drug: Comparator: A-Phase: low molecular weight heparin, unfractionated heparin Drug: Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hours Drug: Duration of Treatment: Z-Phase, 2 years.	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Controlled, Double-Blind Trial to Investigate the Clinical Efficacy and Tolerability of Early Treatment With Simvastatin 40 mg Daily for 30 Days, Followed by Simvastatin 80 mg Daily Thereafter in Tirofiban-Treated Acute Coronary Syndrome Patients Who Have Been Randomized to Receive Enoxaparin or Unfractionated Heparin in Conjunction With Aspirin

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Chest Pain Diets Heart Attack

Drug Information available for: Simvastatin Tirofiban hydrochloride Tirofiban Tirofiban hydrochloride monohydrate Heparin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Z-Phase: combined frequency of the following clinical endpoint events: cardiovascular death, MI, readmission for ACS.

Secondary Outcome Measures:

Z-Phase: the incidence of the following endpoints, evaluated individually and as a composite: cardiovascular death, MI, readmission for ACS, coronary revascularization due to documented ischemia and non-hemorrhagic stroke.

Estimated Enrollment:	5000
Study Start Date:	December 1999

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A-Phase: Chest pain at rest for 10 minutes, EKG changes or elevated cardiac blood work
Z-Phase: elevated cholesterol , plus at least one risk factor ( > 70 years old, diabetes, history of prior heart or blood vessel disease, chest pain with EKG changes, elevation of cardiac lab work or positive cardiac tests , at least 2 heart vessels blocked [one >= 75% and one >= 50%])

Exclusion Criteria:

A-Phase: use of some specific cardiac drugs, high risk bleeding, prior blood clotting disorders
Z-Phase: elevation in certain cardiac blood tests, no significant heart damage at catheterization, planned cardiac surgery or specific cardiac drugs that lower cholesterol levels, within 6 weeks of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251576

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Morrow DA, de Lemos JA, Blazing MA, Sabatine MS, Murphy SA, Jarolim P, White HD, Fox KA, Califf RM, Braunwald E; A to Z Investigators. Prognostic value of serial B-type natriuretic peptide testing during follow-up of patients with unstable coronary artery disease. JAMA. 2005 Dec 14;294(22):2866-71.

de Lemos JA, Blazing MA, Wiviott SD, Brady WE, White HD, Fox KA, Palmisano J, Ramsey KE, Bilheimer DW, Lewis EF, Pfeffer M, Califf RM, Braunwald E; A to Z Investigators. Enoxaparin versus unfractionated heparin in patients treated with tirofiban, aspirin and an early conservative initial management strategy: results from the A phase of the A-to-Z trial. Eur Heart J. 2004 Oct;25(19):1688-94.

de Lemos JA, Blazing MA, Wiviott SD, Lewis EF, Fox KA, White HD, Rouleau JL, Pedersen TR, Gardner LH, Mukherjee R, Ramsey KE, Palmisano J, Bilheimer DW, Pfeffer MA, Califf RM, Braunwald E; A to Z Investigators. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA. 2004 Sep 15;292(11):1307-16. Epub 2004 Aug 30.

Morrow DA, de Lemos JA, Sabatine MS, Wiviott SD, Blazing MA, Shui A, Rifai N, Califf RM, Braunwald E. Clinical relevance of C-reactive protein during follow-up of patients with acute coronary syndromes in the Aggrastat-to-Zocor Trial. Circulation. 2006 Jul 25;114(4):281-8. Epub 2006 Jul 17.

Wiviott SD, de Lemos JA, Cannon CP, Blazing M, Murphy SA, McCabe CH, Califf R, Braunwald E. A tale of two trials: a comparison of the post-acute coronary syndrome lipid-lowering trials A to Z and PROVE IT-TIMI 22. Circulation. 2006 Mar 21;113(11):1406-14. Epub 2006 Mar 13.

de Lemos JA, Wiviott SD, Murphy SA, Blazing MA, Lewis EF, Califf RM, Pfeffer MA, Braunwald E. Evaluation of the National Cholesterol Education Program Adult Treatment Panel III algorithm for selecting candidates for statin therapy: insights from the A to Z trial. Am J Cardiol. 2006 Sep 15;98(6):739-42. Epub 2006 Jul 26.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Morrow DA, Wiviott SD, White HD, Nicolau JC, Bramucci E, Murphy SA, Bonaca MP, Ruff CT, Scirica BM, McCabe CH, Antman EM, Braunwald E. Effect of the novel thienopyridine prasugrel compared with clopidogrel on spontaneous and procedural myocardial infarction in the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-thrombolysis in myocardial infarction 38: an application of the classification system from the universal definition of myocardial infarction. Circulation. 2009 Jun 2;119(21):2758-64. Epub 2009 May 18.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_101, MK0733-180
Study First Received:	November 9, 2005
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00251576 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Tirofiban
Heparin, Low-Molecular-Weight
Myocardial Ischemia
Hematologic Agents
Fibrinolytic Agents
Calcium heparin
Fibrin Modulating Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Cardiovascular Diseases
Heparin

Heart Diseases
Disease
Anticoagulants
Simvastatin
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Acute Coronary Syndrome
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010