Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00251576

Collaborator

(none)

4,497

Enrollment

52.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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 3

Study Design

Study Type:

Interventional

Actual Enrollment :

4497 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 1, 1999

Actual Primary Completion Date :

Mar 23, 2004

Actual Study Completion Date :

Mar 23, 2004

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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