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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4497 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-01

Study Completion Date

2004-03-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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A-Phase: tirofiban; Z-Phase simvastatin

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Duration of Treatment: Z-Phase, 2 years.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No