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Completed

NCT Number: NCT00251576

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

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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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Nov 10, 2005
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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