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

Tracking Information

First Received Date ^ICMJE

November 9, 2005

Last Updated Date

September 17, 2009

Start Date ^ICMJE

December 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00251576 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Prevention

Condition ^ICMJE

Acute Coronary Syndrome

Intervention ^ICMJE

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.

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

5000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00251576

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_101, MK0733-180

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP