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

Sponsored by:	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
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.

Condition

Intervention

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.

MedlinePlus related topics: Blood Thinners Chest Pain Heart Attack

Drug Information available for: Heparin Simvastatin Acetylsalicylic acid Enoxaparin Sodium Tirofiban Tirofiban hydrochloride Tirofiban hydrochloride monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, 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

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 of Results:

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.

Other Publications:

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.

Study ID Numbers:	2005_101
Study First Received:	November 9, 2005
Last Updated:	October 3, 2006
ClinicalTrials.gov Identifier:	NCT00251576
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Simvastatin
Heparin, Low-Molecular-Weight
Myocardial Ischemia
Tirofiban
Vascular Diseases
Pain
Ischemia

Enoxaparin
Chest Pain
Calcium heparin
Calcium, Dietary
Aspirin
Acute Coronary Syndrome
Myocardial Infarction
Heparin

Additional relevant MeSH terms:

Antimetabolites
Disease
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Hematologic Agents
Enzyme Inhibitors
Fibrinolytic Agents
Anticholesteremic Agents

Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Fibrin Modulating Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009