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

Organon

Status and phase

Completed

Phase 3

Conditions

Acute Coronary Syndrome

Treatments

Drug: Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years

Drug: Duration of Treatment: Z-Phase, 2 years.

Drug: Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hours

Drug: Comparator: A-Phase: low molecular weight heparin, unfractionated heparin

Drug: A-Phase: tirofiban; Z-Phase simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00251576

2005_101

0733-180

Details and patient eligibility

About

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.

Enrollment

4,497 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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